Ignite Creation Date:
2025-12-25 @ 2:47 AM
Ignite Modification Date:
2026-01-01 @ 5:33 AM
Study NCT ID:
NCT00351533
Status:
COMPLETED
Last Update Posted:
2011-10-03
First Post:
2006-07-11
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Phase II Randomized Trial of Fish Oil in Patients With Acute Lung Injury (ALI)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012128', 'term': 'Respiratory Distress Syndrome'}, {'id': 'D055371', 'term': 'Acute Lung Injury'}], 'ancestors': [{'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D012120', 'term': 'Respiration Disorders'}, {'id': 'D055370', 'term': 'Lung Injury'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005395', 'term': 'Fish Oils'}, {'id': 'D015118', 'term': 'Eicosapentaenoic Acid'}], 'ancestors': [{'id': 'D009821', 'term': 'Oils'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': 'D015525', 'term': 'Fatty Acids, Omega-3'}, {'id': 'D004042', 'term': 'Dietary Fats, Unsaturated'}, {'id': 'D004041', 'term': 'Dietary Fats'}, {'id': 'D005223', 'term': 'Fats'}, {'id': 'D015777', 'term': 'Eicosanoids'}, {'id': 'D005231', 'term': 'Fatty Acids, Unsaturated'}, {'id': 'D005227', 'term': 'Fatty Acids'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'renee.stapleton@uvm.edu', 'phone': '802-656-7975', 'title': 'Renee Stapleton, MD PhD', 'organization': 'University of Vermont'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': '28 days from day of study enrollment', 'eventGroups': [{'id': 'EG000', 'title': 'Enteral Fish Oil', 'description': '7.5cc of enteral fish oil every 6 hours equalling 9.75g EPA and 6.75g DHA daily', 'otherNumAtRisk': 41, 'otherNumAffected': 24, 'seriousNumAtRisk': 41, 'seriousNumAffected': 12}, {'id': 'EG001', 'title': 'Enteral Saline', 'description': '7.5cc 0.9% saline every 6 hours', 'otherNumAtRisk': 49, 'otherNumAffected': 27, 'seriousNumAtRisk': 49, 'seriousNumAffected': 10}], 'otherEvents': [{'term': 'Total Infections', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 51, 'numAffected': 24}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 50, 'numAffected': 27}], 'organSystem': 'Infections and infestations'}], 'seriousEvents': [{'term': 'Atrial fibrillation with rapid ventricular response', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Cardiac disorders'}, {'term': 'Renal failure requiring renal replacement therapy', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Renal and urinary disorders'}, {'term': 'Pleural and pericardial effusions', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'Critical hypoxemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'Trombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders'}, {'term': 'Fulminant liver failure', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Hepatobiliary disorders'}, {'term': 'Right eye blindness after prolonged prone surgery', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Eye disorders'}, {'term': 'Recurrent falls', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders'}, {'term': 'Aspiration with reintubation', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'Pneumothorax', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 2, 'numAffected': 2}], 'organSystem': 'Respiratory, thoracic and mediastinal disorders'}, {'term': 'Nosocomial sepsis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations'}, {'term': 'PEA arrest', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders'}, {'term': 'Erythema multiforme minor', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Skin and subcutaneous tissue disorders'}, {'term': 'Delayed spinal cord contusion and injury', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Nervous system disorders'}, {'term': 'Severe hypotension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Vascular disorders'}, {'term': 'Pericardial tamponade', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Cardiac disorders'}, {'term': 'Retroperitoneal hematoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 41, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 49, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Blood and lymphatic system disorders'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Bronchoalveolar Lavage Fluid (BALF) Interleukin (IL)-8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Enteral Fish Oil', 'description': '7.5cc of enteral fish oil every 6 hours equalling 9.75g EPA and 6.75g DHA daily'}, {'id': 'OG001', 'title': 'Enteral Saline', 'description': '7.5cc 0.9% saline every 6 hours'}], 'classes': [{'categories': [{'measurements': [{'value': '43', 'groupId': 'OG000', 'lowerLimit': '-656', 'upperLimit': '604'}, {'value': '-241', 'groupId': 'OG001', 'lowerLimit': '-807', 'upperLimit': '349'}]}]}], 'analyses': [{'pValue': '0.37', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': 'Days 1 and 5', 'description': '30 patients in the fish oil group and 36 patients in the enteral saline group underwent the 2nd bronchoalveolar lavage (BAL). Participants did not undergo BALs after baseline if they were not intubated or had expired, but clinical followup data (e.g. mortality) were collected.', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED', 'populationDescription': 'The primary outcome was \\>=50% reduction in BALF IL-8, measured as the change from baseline to day 5. With α=0.05 and β=0.2, we calculated that 26 patients per group were needed if participants underwent two BALs. Analysis was intention to treat (ITT).'}, {'type': 'SECONDARY', 'title': 'Change in BALF Leukotriene B4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Enteral Fish Oil', 'description': '7.5cc of enteral fish oil every 6 hours equalling 9.75g EPA and 6.75g DHA daily'}, {'id': 'OG001', 'title': 'Enteral Saline', 'description': '7.5cc 0.9% saline every 6 hours'}], 'classes': [{'categories': [{'measurements': [{'value': '6', 'groupId': 'OG000', 'lowerLimit': '-1', 'upperLimit': '14'}, {'value': '-2', 'groupId': 'OG001', 'lowerLimit': '-26', 'upperLimit': '9'}]}]}], 'analyses': [{'pValue': '0.04', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': 'Days 1 and 5', 'description': '30 patients in the fish oil group and 36 patients in the enteral saline group underwent the 2nd bronchoalveolar lavage (BAL). Participants did not undergo BALs after baseline if they were not intubated or had expired, but clinical followup data (e.g. mortality) were collected.', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in BALF Interleukin-6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Enteral Fish Oil', 'description': '7.5cc of enteral fish oil every 6 hours equalling 9.75g EPA and 6.75g DHA daily'}, {'id': 'OG001', 'title': 'Enteral Saline', 'description': '7.5cc 0.9% saline every 6 hours'}], 'classes': [{'categories': [{'measurements': [{'value': '-24', 'groupId': 'OG000', 'lowerLimit': '-340', 'upperLimit': '51'}, {'value': '-200', 'groupId': 'OG001', 'lowerLimit': '-692', 'upperLimit': '0'}]}]}], 'analyses': [{'pValue': '0.16', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': 'Days 1 and 5', 'description': '30 patients in the fish oil group and 36 patients in the enteral saline group underwent the 2nd bronchoalveolar lavage (BAL). Participants did not undergo BALs after baseline if they were not intubated or had expired, but clinical followup data (e.g. mortality) were collected.', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in BALF Monocyte Chemotactic Protein-1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Enteral Fish Oil', 'description': '7.5cc of enteral fish oil every 6 hours equalling 9.75g EPA and 6.75g DHA daily'}, {'id': 'OG001', 'title': 'Enteral Saline', 'description': '7.5cc 0.9% saline every 6 hours'}], 'classes': [{'categories': [{'measurements': [{'value': '-150', 'groupId': 'OG000', 'lowerLimit': '-1812', 'upperLimit': '93'}, {'value': '-226', 'groupId': 'OG001', 'lowerLimit': '-752', 'upperLimit': '-38'}]}]}], 'analyses': [{'pValue': '0.79', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': 'Days 1 and 5', 'description': '30 patients in the fish oil group and 36 patients in the enteral saline group underwent the 2nd bronchoalveolar lavage (BAL). Participants did not undergo BALs after baseline if they were not intubated or had expired, but clinical followup data (e.g. mortality) were collected.', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in BALF Neutrophil Count', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Enteral Fish Oil', 'description': '7.5cc of enteral fish oil every 6 hours equalling 9.75g EPA and 6.75g DHA daily'}, {'id': 'OG001', 'title': 'Enteral Saline', 'description': '7.5cc 0.9% saline every 6 hours'}], 'classes': [{'categories': [{'measurements': [{'value': '-3', 'groupId': 'OG000', 'lowerLimit': '-19', 'upperLimit': '12'}, {'value': '-10', 'groupId': 'OG001', 'lowerLimit': '-21', 'upperLimit': '7'}]}]}], 'analyses': [{'pValue': '0.34', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': 'Days 1 and 5', 'description': '30 patients in the fish oil group and 36 patients in the enteral saline group underwent the 2nd bronchoalveolar lavage (BAL). Participants did not undergo BALs after baseline if they were not intubated or had expired, but clinical followup data (e.g. mortality) were collected.', 'unitOfMeasure': '# of cells/mm^3', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Static Lung Compliance', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Enteral Fish Oil', 'description': '7.5cc of enteral fish oil every 6 hours equalling 9.75g EPA and 6.75g DHA daily'}, {'id': 'OG001', 'title': 'Enteral Saline', 'description': '7.5cc 0.9% saline every 6 hours'}], 'classes': [{'categories': [{'measurements': [{'value': '31.8', 'spread': '10.1', 'groupId': 'OG000'}, {'value': '36.3', 'spread': '20.1', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.26', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Day 5', 'description': '30 patients in the fish oil group and 36 patients in the enteral saline group remained intubated on day 5 and had this outcome available.', 'unitOfMeasure': 'L/cm H20', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Oxygenation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Enteral Fish Oil', 'description': '7.5cc of enteral fish oil every 6 hours equalling 9.75g EPA and 6.75g DHA daily'}, {'id': 'OG001', 'title': 'Enteral Saline', 'description': '7.5cc 0.9% saline every 6 hours'}], 'classes': [{'categories': [{'measurements': [{'value': '215.4', 'spread': '92.8', 'groupId': 'OG000'}, {'value': '174.0', 'spread': '63.4', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.06', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Day 5', 'description': 'PaO2/FiO2 is the ratio of partial pressure of arterial oxygen to the fraction of inspired oxygen. 30 patients in the fish oil group and 36 patients in the enteral saline group remained intubated on day 5 and had this outcome available.', 'unitOfMeasure': 'PaO2/FiO2', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Plasma Interleukin-8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Enteral Fish Oil', 'description': '7.5cc of enteral fish oil every 6 hours equalling 9.75g EPA and 6.75g DHA daily'}, {'id': 'OG001', 'title': 'Enteral Saline', 'description': '7.5cc 0.9% saline every 6 hours'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '-8', 'upperLimit': '0'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '-13', 'upperLimit': '0'}]}]}], 'analyses': [{'pValue': '0.89', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': 'Days 1 and 5', 'description': '30 patients in the fish oil group and 36 patients in the enteral saline group underwent 2nd blood draw on day 5. Participants did not undergo blood draws after baseline if they were discharged from the ICU or had expired, but clinical followup data (e.g. mortality) were collected.', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Plasma Leukotriene B4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Enteral Fish Oil', 'description': '7.5cc of enteral fish oil every 6 hours equalling 9.75g EPA and 6.75g DHA daily'}, {'id': 'OG001', 'title': 'Enteral Saline', 'description': '7.5cc 0.9% saline every 6 hours'}], 'classes': [{'categories': [{'measurements': [{'value': '21', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '32'}, {'value': '-6', 'groupId': 'OG001', 'lowerLimit': '-35', 'upperLimit': '7'}]}]}], 'analyses': [{'pValue': '0.002', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': 'Days 1 and 5', 'description': '30 patients in the fish oil group and 36 patients in the enteral saline group underwent 2nd blood draw on day 5. Participants did not undergo blood draws after baseline if they were discharged from the ICU or had expired, but clinical followup data (e.g. mortality) were collected.', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Plasma Interleukin-6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Enteral Fish Oil', 'description': '7.5cc of enteral fish oil every 6 hours equalling 9.75g EPA and 6.75g DHA daily'}, {'id': 'OG001', 'title': 'Enteral Saline', 'description': '7.5cc 0.9% saline every 6 hours'}], 'classes': [{'categories': [{'measurements': [{'value': '-33', 'groupId': 'OG000', 'lowerLimit': '-162', 'upperLimit': '-13'}, {'value': '-78', 'groupId': 'OG001', 'lowerLimit': '-163', 'upperLimit': '-29'}]}]}], 'analyses': [{'pValue': '0.27', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': 'Days 1 and 5', 'description': '30 patients in the fish oil group and 36 patients in the enteral saline group underwent 2nd blood draw on day 5. Participants did not undergo blood draws after baseline if they were discharged from the ICU or had expired, but clinical followup data (e.g. mortality) were collected.', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Plasma Surfactant Protein D', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Enteral Fish Oil', 'description': '7.5cc of enteral fish oil every 6 hours equalling 9.75g EPA and 6.75g DHA daily'}, {'id': 'OG001', 'title': 'Enteral Saline', 'description': '7.5cc 0.9% saline every 6 hours'}], 'classes': [{'categories': [{'measurements': [{'value': '25', 'groupId': 'OG000', 'lowerLimit': '0', 'upperLimit': '32'}, {'value': '36', 'groupId': 'OG001', 'lowerLimit': '1', 'upperLimit': '139'}]}]}], 'analyses': [{'pValue': '0.20', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': 'Days 1 and 5', 'description': '30 patients in the fish oil group and 36 patients in the enteral saline group underwent 2nd blood draw on day 5. Participants did not undergo blood draws after baseline if they were discharged from the ICU or had expired, but clinical followup data (e.g. mortality) were collected.', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Plasma vonWillebrand Factor', 'denoms': [{'units': 'Participants', 'counts': [{'value': '30', 'groupId': 'OG000'}, {'value': '36', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Enteral Fish Oil', 'description': '7.5cc of enteral fish oil every 6 hours equalling 9.75g EPA and 6.75g DHA daily'}, {'id': 'OG001', 'title': 'Enteral Saline', 'description': '7.5cc 0.9% saline every 6 hours'}], 'classes': [{'categories': [{'measurements': [{'value': '15', 'groupId': 'OG000', 'lowerLimit': '-103', 'upperLimit': '158'}, {'value': '68', 'groupId': 'OG001', 'lowerLimit': '21', 'upperLimit': '206'}]}]}], 'analyses': [{'pValue': '0.11', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': 'Days 1 and 5', 'description': '30 patients in the fish oil group and 36 patients in the enteral saline group underwent 2nd blood draw on day 5. Participants did not undergo blood draws after baseline if they were discharged from the ICU or had expired, but clinical followup data (e.g. mortality) were collected.', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Worst Multiple Organ Dysfunction Score (MODS) During First 28 Days After Study Enrollment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Enteral Fish Oil', 'description': '7.5cc of enteral fish oil every 6 hours equalling 9.75g EPA and 6.75g DHA daily'}, {'id': 'OG001', 'title': 'Enteral Saline', 'description': '7.5cc 0.9% saline every 6 hours'}], 'classes': [{'categories': [{'measurements': [{'value': '8.5', 'spread': '3.1', 'groupId': 'OG000'}, {'value': '8.1', 'spread': '3.3', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.56', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'Throughout hospital stay', 'description': 'Full scale name is Multiple Organ Dysfunction Score (MODS), a scale measuring degree of organ dysfunction in critically ill patients.\n\nMinimum score is 0 and maximum score is 24, with 0 indicating no organ failure and 24 indicating severe failure of multiple organs.', 'unitOfMeasure': 'Scores on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Ventilator-free Days During First 28 Days After Study Enrollment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Enteral Fish Oil', 'description': '7.5cc of enteral fish oil every 6 hours equalling 9.75g EPA and 6.75g DHA daily'}, {'id': 'OG001', 'title': 'Enteral Saline', 'description': '7.5cc 0.9% saline every 6 hours'}], 'classes': [{'categories': [{'measurements': [{'value': '14.5', 'spread': '10.3', 'groupId': 'OG000'}, {'value': '13.6', 'spread': '9.9', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.69', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '28 days', 'description': 'Ventilator-free days is a common outcome measure in critical care research. A ventilator-free day is a day that a participant is alive and not receiving mechanical ventilation during the first 28 days after s/he enrolled in the study.', 'unitOfMeasure': 'Days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'ICU-free Days During First 28 Days After Study Enrollment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Enteral Fish Oil', 'description': '7.5cc of enteral fish oil every 6 hours equalling 9.75g EPA and 6.75g DHA daily'}, {'id': 'OG001', 'title': 'Enteral Saline', 'description': '7.5cc 0.9% saline every 6 hours'}], 'classes': [{'categories': [{'measurements': [{'value': '12.2', 'spread': '9.8', 'groupId': 'OG000'}, {'value': '11.2', 'spread': '9.7', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.66', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': '28 days', 'description': 'ICU-free days is a common outcome measure in critical care research. An ICU-free day is a day that a participant is alive and not in the intensive care unit (ICU) during the first 28 days after s/he enrolled in the study.', 'unitOfMeasure': 'Days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Hospital Length of Stay', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Enteral Fish Oil', 'description': '7.5cc of enteral fish oil every 6 hours equalling 9.75g EPA and 6.75g DHA daily'}, {'id': 'OG001', 'title': 'Enteral Saline', 'description': '7.5cc 0.9% saline every 6 hours'}], 'classes': [{'categories': [{'measurements': [{'value': '23', 'spread': '18.3', 'groupId': 'OG000'}, {'value': '27.6', 'spread': '20.6', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.27', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEAN', 'timeFrame': 'At end of hospital admission', 'unitOfMeasure': 'Days', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Hospital Mortality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '48', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Enteral Fish Oil', 'description': '7.5cc of enteral fish oil every 6 hours equalling 9.75g EPA and 6.75g DHA daily'}, {'id': 'OG001', 'title': 'Enteral Saline', 'description': '7.5cc 0.9% saline every 6 hours'}], 'classes': [{'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '10', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.65', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': 'At end of hospitalization', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': '60-day Mortality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'OG000'}, {'value': '45', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Enteral Fish Oil', 'description': '7.5cc of enteral fish oil every 6 hours equalling 9.75g EPA and 6.75g DHA daily'}, {'id': 'OG001', 'title': 'Enteral Saline', 'description': '7.5cc 0.9% saline every 6 hours'}], 'classes': [{'categories': [{'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '11', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.49', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'NUMBER', 'timeFrame': '60 days from day of enrollment into study', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Bronchoalveolar Lavage Fluid (BALF) Interleukin (IL)-8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Enteral Fish Oil', 'description': '7.5cc of enteral fish oil every 6 hours equalling 9.75g EPA and 6.75g DHA daily'}, {'id': 'OG001', 'title': 'Enteral Saline', 'description': '7.5cc 0.9% saline every 6 hours'}], 'classes': [{'categories': [{'measurements': [{'value': '-531', 'groupId': 'OG000', 'lowerLimit': '-1308', 'upperLimit': '94'}, {'value': '-298', 'groupId': 'OG001', 'lowerLimit': '-870', 'upperLimit': '397'}]}]}], 'analyses': [{'pValue': '0.55', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': 'Days 1 and 9', 'description': '15 patients in the fish oil group and 27 patients in the enteral saline group underwent the 3rd bronchoalveolar lavage (BAL). Participants did not undergo BALs after baseline if they were not intubated or had expired, but clinical followup data (e.g. mortality) were collected.', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in BALF Leukotriene B4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Enteral Fish Oil', 'description': '7.5cc of enteral fish oil every 6 hours equalling 9.75g EPA and 6.75g DHA daily'}, {'id': 'OG001', 'title': 'Enteral Saline', 'description': '7.5cc 0.9% saline every 6 hours'}], 'classes': [{'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000', 'lowerLimit': '-2', 'upperLimit': '33'}, {'value': '16', 'groupId': 'OG001', 'lowerLimit': '0', 'upperLimit': '50'}]}]}], 'analyses': [{'pValue': '0.38', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': 'Days 1 and 9', 'description': '15 patients in the fish oil group and 27 patients in the enteral saline group underwent the 3rd bronchoalveolar lavage (BAL). Participants did not undergo BALs after baseline if they were not intubated or had expired, but clinical followup data (e.g. mortality) were collected.', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in BALF Interleukin-6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Enteral Fish Oil', 'description': '7.5cc of enteral fish oil every 6 hours equalling 9.75g EPA and 6.75g DHA daily'}, {'id': 'OG001', 'title': 'Enteral Saline', 'description': '7.5cc 0.9% saline every 6 hours'}], 'classes': [{'categories': [{'measurements': [{'value': '-52', 'groupId': 'OG000', 'lowerLimit': '-898', 'upperLimit': '0'}, {'value': '-198', 'groupId': 'OG001', 'lowerLimit': '-865', 'upperLimit': '-17'}]}]}], 'analyses': [{'pValue': '0.84', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': 'Days 1 and 9', 'description': '15 patients in the fish oil group and 27 patients in the enteral saline group underwent the 3rd bronchoalveolar lavage (BAL). Participants did not undergo BALs after baseline if they were not intubated or had expired, but clinical followup data (e.g. mortality) were collected.', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in BALF Monocyte Chemotactic Protein-1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Enteral Fish Oil', 'description': '7.5cc of enteral fish oil every 6 hours equalling 9.75g EPA and 6.75g DHA daily'}, {'id': 'OG001', 'title': 'Enteral Saline', 'description': '7.5cc 0.9% saline every 6 hours'}], 'classes': [{'categories': [{'measurements': [{'value': '-402', 'groupId': 'OG000', 'lowerLimit': '-1690', 'upperLimit': '-41'}, {'value': '-670', 'groupId': 'OG001', 'lowerLimit': '-1057', 'upperLimit': '-151'}]}]}], 'analyses': [{'pValue': '0.74', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': 'Days 1 and 9', 'description': '15 patients in the fish oil group and 27 patients in the enteral saline group underwent the 3rd bronchoalveolar lavage (BAL). Participants did not undergo BALs after baseline if they were not intubated or had expired, but clinical followup data (e.g. mortality) were collected.', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in BALF Neutrophil Count', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Enteral Fish Oil', 'description': '7.5cc of enteral fish oil every 6 hours equalling 9.75g EPA and 6.75g DHA daily'}, {'id': 'OG001', 'title': 'Enteral Saline', 'description': '7.5cc 0.9% saline every 6 hours'}], 'classes': [{'categories': [{'measurements': [{'value': '-4', 'groupId': 'OG000', 'lowerLimit': '-48', 'upperLimit': '8'}, {'value': '-10', 'groupId': 'OG001', 'lowerLimit': '-56', 'upperLimit': '15'}]}]}], 'analyses': [{'pValue': '0.84', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': 'Days 1 and 9', 'description': '15 patients in the fish oil group and 27 patients in the enteral saline group underwent the 3rd bronchoalveolar lavage (BAL). Participants did not undergo BALs after baseline if they were not intubated or had expired, but clinical followup data (e.g. mortality) were collected.', 'unitOfMeasure': '# of cells/mm^3', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Plasma Interleukin-8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Enteral Fish Oil', 'description': '7.5cc of enteral fish oil every 6 hours equalling 9.75g EPA and 6.75g DHA daily'}, {'id': 'OG001', 'title': 'Enteral Saline', 'description': '7.5cc 0.9% saline every 6 hours'}], 'classes': [{'categories': [{'measurements': [{'value': '-1', 'groupId': 'OG000', 'lowerLimit': '-17', 'upperLimit': '0'}, {'value': '0', 'groupId': 'OG001', 'lowerLimit': '-15', 'upperLimit': '2'}]}]}], 'analyses': [{'pValue': '0.71', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': 'Days 1 and 9', 'description': '15 patients in the fish oil group and 27 patients in the enteral saline group underwent 3rd blood draw on day 9. Participants did not undergo blood draws after baseline if they were discharged from the ICU or had expired, but clinical followup data (e.g. mortality) were collected.', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Plasma Leukotriene B4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Enteral Fish Oil', 'description': '7.5cc of enteral fish oil every 6 hours equalling 9.75g EPA and 6.75g DHA daily'}, {'id': 'OG001', 'title': 'Enteral Saline', 'description': '7.5cc 0.9% saline every 6 hours'}], 'classes': [{'categories': [{'measurements': [{'value': '10', 'groupId': 'OG000', 'lowerLimit': '3', 'upperLimit': '40'}, {'value': '6', 'groupId': 'OG001', 'lowerLimit': '-22', 'upperLimit': '14'}]}]}], 'analyses': [{'pValue': '0.08', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': 'Days 1 and 9', 'description': '15 patients in the fish oil group and 27 patients in the enteral saline group underwent 3rd blood draw on day 9. Participants did not undergo blood draws after baseline if they were discharged from the ICU or had expired, but clinical followup data (e.g. mortality) were collected.', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Plasma Interleukin-6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Enteral Fish Oil', 'description': '7.5cc of enteral fish oil every 6 hours equalling 9.75g EPA and 6.75g DHA daily'}, {'id': 'OG001', 'title': 'Enteral Saline', 'description': '7.5cc 0.9% saline every 6 hours'}], 'classes': [{'categories': [{'measurements': [{'value': '-83', 'groupId': 'OG000', 'lowerLimit': '-174', 'upperLimit': '14'}, {'value': '-78', 'groupId': 'OG001', 'lowerLimit': '-163', 'upperLimit': '-29'}]}]}], 'analyses': [{'pValue': '0.86', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': 'Days 1 and 9', 'description': '15 patients in the fish oil group and 27 patients in the enteral saline group underwent 3rd blood draw on day 9. Participants did not undergo blood draws after baseline if they were discharged from the ICU or had expired, but clinical followup data (e.g. mortality) were collected.', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Plasma Surfactant Protein D', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Enteral Fish Oil', 'description': '7.5cc of enteral fish oil every 6 hours equalling 9.75g EPA and 6.75g DHA daily'}, {'id': 'OG001', 'title': 'Enteral Saline', 'description': '7.5cc 0.9% saline every 6 hours'}], 'classes': [{'categories': [{'measurements': [{'value': '26', 'groupId': 'OG000', 'lowerLimit': '-12', 'upperLimit': '78'}, {'value': '17', 'groupId': 'OG001', 'lowerLimit': '-36', 'upperLimit': '68'}]}]}], 'analyses': [{'pValue': '0.89', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': 'Days 1 and 9', 'description': '15 patients in the fish oil group and 27 patients in the enteral saline group underwent 3rd blood draw on day 9. Participants did not undergo blood draws after baseline if they were discharged from the ICU or had expired, but clinical followup data (e.g. mortality) were collected.', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in Plasma vonWillebrand Factor', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15', 'groupId': 'OG000'}, {'value': '27', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Enteral Fish Oil', 'description': '7.5cc of enteral fish oil every 6 hours equalling 9.75g EPA and 6.75g DHA daily'}, {'id': 'OG001', 'title': 'Enteral Saline', 'description': '7.5cc 0.9% saline every 6 hours'}], 'classes': [{'categories': [{'measurements': [{'value': '116', 'groupId': 'OG000', 'lowerLimit': '-9', 'upperLimit': '235'}, {'value': '43', 'groupId': 'OG001', 'lowerLimit': '-21', 'upperLimit': '164'}]}]}], 'analyses': [{'pValue': '0.34', 'groupIds': ['OG000', 'OG001'], 'ciPctValue': '95', 'statisticalMethod': 'Wilcoxon (Mann-Whitney)', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'testedNonInferiority': False}], 'paramType': 'MEDIAN', 'timeFrame': 'Days 1 and 9', 'description': '15 patients in the fish oil group and 27 patients in the enteral saline group underwent 3rd blood draw on day 9. Participants did not undergo blood draws after baseline if they were discharged from the ICU or had expired, but clinical followup data (e.g. mortality) were collected.', 'unitOfMeasure': 'pg/mL', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Enteral Fish Oil', 'description': '7.5cc of enteral fish oil every 6 hours equalling 9.75g EPA and 6.75g DHA daily'}, {'id': 'FG001', 'title': 'Enteral Saline', 'description': '7.5cc 0.9% saline every 6 hours'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '41'}, {'groupId': 'FG001', 'numSubjects': '49'}]}, {'type': 'COMPLETED', 'achievements': [{'comment': 'Pts did not undergo BALs if not intubated', 'groupId': 'FG000', 'numSubjects': '39'}, {'comment': 'Pts did not undergo BALs if not intubated', 'groupId': 'FG001', 'numSubjects': '44'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '5'}]}], 'dropWithdraws': [{'type': 'Extubated before first BAL', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '3'}]}, {'type': 'Physician Decision', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '41', 'groupId': 'BG000'}, {'value': '49', 'groupId': 'BG001'}, {'value': '90', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Enteral Fish Oil', 'description': '7.5cc of enteral fish oil every 6 hours equalling 9.75g EPA and 6.75g DHA daily'}, {'id': 'BG001', 'title': 'Enteral Saline', 'description': '7.5cc 0.9% saline every 6 hours'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age Continuous', 'classes': [{'categories': [{'measurements': [{'value': '49.0', 'spread': '16.5', 'groupId': 'BG000'}, {'value': '50.7', 'spread': '16.5', 'groupId': 'BG001'}, {'value': '49.9', 'spread': '16.4', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '33', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '24', 'groupId': 'BG000'}, {'value': '33', 'groupId': 'BG001'}, {'value': '57', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 90}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-08', 'completionDateStruct': {'date': '2009-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-08-26', 'studyFirstSubmitDate': '2006-07-11', 'resultsFirstSubmitDate': '2011-02-16', 'studyFirstSubmitQcDate': '2006-07-11', 'lastUpdatePostDateStruct': {'date': '2011-10-03', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2011-08-26', 'studyFirstPostDateStruct': {'date': '2006-07-13', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-10-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Bronchoalveolar Lavage Fluid (BALF) Interleukin (IL)-8', 'timeFrame': 'Days 1 and 5', 'description': '30 patients in the fish oil group and 36 patients in the enteral saline group underwent the 2nd bronchoalveolar lavage (BAL). Participants did not undergo BALs after baseline if they were not intubated or had expired, but clinical followup data (e.g. mortality) were collected.'}], 'secondaryOutcomes': [{'measure': 'Change in BALF Leukotriene B4', 'timeFrame': 'Days 1 and 5', 'description': '30 patients in the fish oil group and 36 patients in the enteral saline group underwent the 2nd bronchoalveolar lavage (BAL). Participants did not undergo BALs after baseline if they were not intubated or had expired, but clinical followup data (e.g. mortality) were collected.'}, {'measure': 'Change in BALF Interleukin-6', 'timeFrame': 'Days 1 and 5', 'description': '30 patients in the fish oil group and 36 patients in the enteral saline group underwent the 2nd bronchoalveolar lavage (BAL). Participants did not undergo BALs after baseline if they were not intubated or had expired, but clinical followup data (e.g. mortality) were collected.'}, {'measure': 'Change in BALF Monocyte Chemotactic Protein-1', 'timeFrame': 'Days 1 and 5', 'description': '30 patients in the fish oil group and 36 patients in the enteral saline group underwent the 2nd bronchoalveolar lavage (BAL). Participants did not undergo BALs after baseline if they were not intubated or had expired, but clinical followup data (e.g. mortality) were collected.'}, {'measure': 'Change in BALF Neutrophil Count', 'timeFrame': 'Days 1 and 5', 'description': '30 patients in the fish oil group and 36 patients in the enteral saline group underwent the 2nd bronchoalveolar lavage (BAL). Participants did not undergo BALs after baseline if they were not intubated or had expired, but clinical followup data (e.g. mortality) were collected.'}, {'measure': 'Static Lung Compliance', 'timeFrame': 'Day 5', 'description': '30 patients in the fish oil group and 36 patients in the enteral saline group remained intubated on day 5 and had this outcome available.'}, {'measure': 'Oxygenation', 'timeFrame': 'Day 5', 'description': 'PaO2/FiO2 is the ratio of partial pressure of arterial oxygen to the fraction of inspired oxygen. 30 patients in the fish oil group and 36 patients in the enteral saline group remained intubated on day 5 and had this outcome available.'}, {'measure': 'Change in Plasma Interleukin-8', 'timeFrame': 'Days 1 and 5', 'description': '30 patients in the fish oil group and 36 patients in the enteral saline group underwent 2nd blood draw on day 5. Participants did not undergo blood draws after baseline if they were discharged from the ICU or had expired, but clinical followup data (e.g. mortality) were collected.'}, {'measure': 'Change in Plasma Leukotriene B4', 'timeFrame': 'Days 1 and 5', 'description': '30 patients in the fish oil group and 36 patients in the enteral saline group underwent 2nd blood draw on day 5. Participants did not undergo blood draws after baseline if they were discharged from the ICU or had expired, but clinical followup data (e.g. mortality) were collected.'}, {'measure': 'Change in Plasma Interleukin-6', 'timeFrame': 'Days 1 and 5', 'description': '30 patients in the fish oil group and 36 patients in the enteral saline group underwent 2nd blood draw on day 5. Participants did not undergo blood draws after baseline if they were discharged from the ICU or had expired, but clinical followup data (e.g. mortality) were collected.'}, {'measure': 'Change in Plasma Surfactant Protein D', 'timeFrame': 'Days 1 and 5', 'description': '30 patients in the fish oil group and 36 patients in the enteral saline group underwent 2nd blood draw on day 5. Participants did not undergo blood draws after baseline if they were discharged from the ICU or had expired, but clinical followup data (e.g. mortality) were collected.'}, {'measure': 'Change in Plasma vonWillebrand Factor', 'timeFrame': 'Days 1 and 5', 'description': '30 patients in the fish oil group and 36 patients in the enteral saline group underwent 2nd blood draw on day 5. Participants did not undergo blood draws after baseline if they were discharged from the ICU or had expired, but clinical followup data (e.g. mortality) were collected.'}, {'measure': 'Worst Multiple Organ Dysfunction Score (MODS) During First 28 Days After Study Enrollment', 'timeFrame': 'Throughout hospital stay', 'description': 'Full scale name is Multiple Organ Dysfunction Score (MODS), a scale measuring degree of organ dysfunction in critically ill patients.\n\nMinimum score is 0 and maximum score is 24, with 0 indicating no organ failure and 24 indicating severe failure of multiple organs.'}, {'measure': 'Ventilator-free Days During First 28 Days After Study Enrollment', 'timeFrame': '28 days', 'description': 'Ventilator-free days is a common outcome measure in critical care research. A ventilator-free day is a day that a participant is alive and not receiving mechanical ventilation during the first 28 days after s/he enrolled in the study.'}, {'measure': 'ICU-free Days During First 28 Days After Study Enrollment', 'timeFrame': '28 days', 'description': 'ICU-free days is a common outcome measure in critical care research. An ICU-free day is a day that a participant is alive and not in the intensive care unit (ICU) during the first 28 days after s/he enrolled in the study.'}, {'measure': 'Hospital Length of Stay', 'timeFrame': 'At end of hospital admission'}, {'measure': 'Hospital Mortality', 'timeFrame': 'At end of hospitalization'}, {'measure': '60-day Mortality', 'timeFrame': '60 days from day of enrollment into study'}, {'measure': 'Change in Bronchoalveolar Lavage Fluid (BALF) Interleukin (IL)-8', 'timeFrame': 'Days 1 and 9', 'description': '15 patients in the fish oil group and 27 patients in the enteral saline group underwent the 3rd bronchoalveolar lavage (BAL). Participants did not undergo BALs after baseline if they were not intubated or had expired, but clinical followup data (e.g. mortality) were collected.'}, {'measure': 'Change in BALF Leukotriene B4', 'timeFrame': 'Days 1 and 9', 'description': '15 patients in the fish oil group and 27 patients in the enteral saline group underwent the 3rd bronchoalveolar lavage (BAL). Participants did not undergo BALs after baseline if they were not intubated or had expired, but clinical followup data (e.g. mortality) were collected.'}, {'measure': 'Change in BALF Interleukin-6', 'timeFrame': 'Days 1 and 9', 'description': '15 patients in the fish oil group and 27 patients in the enteral saline group underwent the 3rd bronchoalveolar lavage (BAL). Participants did not undergo BALs after baseline if they were not intubated or had expired, but clinical followup data (e.g. mortality) were collected.'}, {'measure': 'Change in BALF Monocyte Chemotactic Protein-1', 'timeFrame': 'Days 1 and 9', 'description': '15 patients in the fish oil group and 27 patients in the enteral saline group underwent the 3rd bronchoalveolar lavage (BAL). Participants did not undergo BALs after baseline if they were not intubated or had expired, but clinical followup data (e.g. mortality) were collected.'}, {'measure': 'Change in BALF Neutrophil Count', 'timeFrame': 'Days 1 and 9', 'description': '15 patients in the fish oil group and 27 patients in the enteral saline group underwent the 3rd bronchoalveolar lavage (BAL). Participants did not undergo BALs after baseline if they were not intubated or had expired, but clinical followup data (e.g. mortality) were collected.'}, {'measure': 'Change in Plasma Interleukin-8', 'timeFrame': 'Days 1 and 9', 'description': '15 patients in the fish oil group and 27 patients in the enteral saline group underwent 3rd blood draw on day 9. Participants did not undergo blood draws after baseline if they were discharged from the ICU or had expired, but clinical followup data (e.g. mortality) were collected.'}, {'measure': 'Change in Plasma Leukotriene B4', 'timeFrame': 'Days 1 and 9', 'description': '15 patients in the fish oil group and 27 patients in the enteral saline group underwent 3rd blood draw on day 9. Participants did not undergo blood draws after baseline if they were discharged from the ICU or had expired, but clinical followup data (e.g. mortality) were collected.'}, {'measure': 'Change in Plasma Interleukin-6', 'timeFrame': 'Days 1 and 9', 'description': '15 patients in the fish oil group and 27 patients in the enteral saline group underwent 3rd blood draw on day 9. Participants did not undergo blood draws after baseline if they were discharged from the ICU or had expired, but clinical followup data (e.g. mortality) were collected.'}, {'measure': 'Change in Plasma Surfactant Protein D', 'timeFrame': 'Days 1 and 9', 'description': '15 patients in the fish oil group and 27 patients in the enteral saline group underwent 3rd blood draw on day 9. Participants did not undergo blood draws after baseline if they were discharged from the ICU or had expired, but clinical followup data (e.g. mortality) were collected.'}, {'measure': 'Change in Plasma vonWillebrand Factor', 'timeFrame': 'Days 1 and 9', 'description': '15 patients in the fish oil group and 27 patients in the enteral saline group underwent 3rd blood draw on day 9. Participants did not undergo blood draws after baseline if they were discharged from the ICU or had expired, but clinical followup data (e.g. mortality) were collected.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Respiratory distress syndrome, adult', 'Acute lung injury', 'Acute respiratory distress syndrome', 'ARDS, human', 'Fish oils', 'Fatty Acids, Omega-3', 'Docosahexaenoic Acids', 'Eicosapentaenoic Acid'], 'conditions': ['Respiratory Distress Syndrome, Adult', 'Acute Lung Injury', 'Acute Respiratory Distress Syndrome']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether fish oil (containing omega-3 fatty acids) given enterally is safe and effective in reducing lung and systemic inflammation seen in acute lung injury.', 'detailedDescription': 'Acute lung injury (ALI) is common among critically ill patients and is associated with a high case fatality. Only one intervention has been shown to improve survival in a large clinical trial, and new therapies targeting the inflammatory response are needed. Nutrient interventions may provide benefit; specifically there is plausible biologic rationale for administering n-3 fatty acids (n-3 FAs) found in fish oil to patients with ALI, as n-3 FAs decrease formation of eicosanoid inflammatory mediators. However, although promising results have emerged from prior studies, fish oils have only been tested in ALI patients in a commercial enteral formula containing additional nutrients, and the control group received a high-fat enteral formula that may have been proinflammatory. Therefore, no conclusion can be drawn about the independent effect of fish oils. Furthermore, the inclusion of key pharmaconutrients in feeding formulas, instead of delivering them separately as pharmaceuticals, limits exposure to the agent, as intensive care unit (ICU) patients commonly receive less than 60% of prescribed caloric needs. Finally, specialized feeding formulas are very expensive, and it may be substantially cheaper to administer pharmaconutrients separately. We believe it is time to begin to approach nutrient trials in critically ill patients differently -- to move away from including them in feeding formulas and begin delivering them like pharmaceuticals. With appropriate scientific investigation and the use of non-nutrient placebos, this novel and innovative approach is a new paradigm of investigating nutrient delivery to critically ill patients.\n\nThis study is a phase II randomized controlled trial to determine the effects of enteral eicosapentaenoic acid (EPA) and docosahexanoic acid (DHA), both n-3 FAs found in fish oil, versus placebo on the pulmonary and systemic environments, and on clinical outcomes, in patients with ALI. We will investigate the effect of fish oil administration on several biological markers of injury and inflammation in bronchoalveolar lavage fluid and serum, on pulmonary physiologic outcomes, and on clinical outcomes.\n\nComparison(s): Mechanically ventilated patients with acute lung injury randomized to receive enteral fish oil versus compared to mechanically ventilated patients with acute lung injury randomized to receive placebo.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Requiring positive-pressure mechanical ventilation\n* ALI criteria: PaO2/FiO2 \\<300, bilateral infiltrates on chest radiograph, no left atrial hypertension\n* Age \\> 17 years\n\nExclusion Criteria:\n\n* Expected ICU length of stay \\<48 hours\n* Unable to undergo bronchoalveolar lavage at enrollment\n* Unable to obtain enteral access\n* Post-cardiac arrest with suspected significant anoxic brain injury\n* Expected survival \\< 28 days\n* Pregnant\n* Platelet count \\< 30,000, active bleeding, or international normalized ratio (INR)\\>3.0\n* History of ventricular tachycardia or fibrillation\n* Receiving recombinant human activated protein C (rh-APC) for sepsis\n* Acquired immune deficiency syndrome (AIDS) with CD4 count \\< 200\n* Metastatic cancer\n* History of bone marrow, lung, liver, cardiac, kidney, or pancreas transplant'}, 'identificationModule': {'nctId': 'NCT00351533', 'briefTitle': 'A Phase II Randomized Trial of Fish Oil in Patients With Acute Lung Injury (ALI)', 'organization': {'class': 'OTHER', 'fullName': 'University of Washington'}, 'officialTitle': 'A Randomized, Double-blind Study of the Effect of Fish Oil (Eicosapentaenoic Acid and Docosahexanoic Acid) on Lung and Systemic Inflammation in Patients With Acute Lung Injury (ALI)', 'orgStudyIdInfo': {'id': '28503-A'}, 'secondaryIdInfos': [{'id': '05-7895-A 03'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Enteral fish oil', 'interventionNames': ['Drug: Fish oil (eicosapentaenoic acid and docosahexanoic acid)']}, {'type': 'PLACEBO_COMPARATOR', 'label': '2', 'description': 'Enteral saline', 'interventionNames': ['Drug: Fish oil (eicosapentaenoic acid and docosahexanoic acid)']}], 'interventions': [{'name': 'Fish oil (eicosapentaenoic acid and docosahexanoic acid)', 'type': 'DRUG', 'description': 'Liquid fish oil 7.5cc enterally every 6 hours', 'armGroupLabels': ['1', '2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '83706', 'city': 'Boise', 'state': 'Idaho', 'country': 'United States', 'facility': 'St. Alphonsus Medical Center', 'geoPoint': {'lat': 43.6135, 'lon': -116.20345}}, {'zip': '97239', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Oregon Health Sciences University', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '05401', 'city': 'Burlington', 'state': 'Vermont', 'country': 'United States', 'facility': 'University of Vermont/Fletcher Allen Health Care', 'geoPoint': {'lat': 44.47588, 'lon': -73.21207}}, {'zip': '98104', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'Harborview Medical Center', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'zip': 'M5B1W8', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': "St. Michael's Hospital", 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'overallOfficials': [{'name': 'Renee D. Stapleton, MD, MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Vermont'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Washington', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Heart, Lung, and Blood Institute (NHLBI)', 'class': 'NIH'}, {'name': 'American Thoracic Society', 'class': 'OTHER'}, {'name': 'Acute Respiratory Distress Syndrome Foundation', 'class': 'OTHER'}, {'name': 'American Society for Parenteral and Enteral Nutrition', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Renee Stapleton', 'investigatorAffiliation': 'University of Washington'}}}}