Ignite Creation Date:
2025-12-24 @ 4:16 PM
Ignite Modification Date:
2025-12-25 @ 3:04 PM
Study NCT ID:
NCT01206166
Status:
TERMINATED
Last Update Posted:
2021-03-16
First Post:
2010-09-14
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Trial of Supplemental Parenteral Nutrition in Under and Over Weight Critically Ill Patients (TOP-UP)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016638', 'term': 'Critical Illness'}], 'ancestors': [{'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'dkh2@queensu.ca', 'phone': '403-915-5573', 'title': 'Dr.Daren Heyland', 'organization': "CERU Queen's University"}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'due to slower than anticipated enrollment and the upcoming end of the funding from the National Institutes of Health the study was prematurely terminated'}}, 'adverseEventsModule': {'timeFrame': '28 days', 'description': 'Given the acuity of illness of critically ill patients, adverse events (defined as any untoward medical occurrences in a patient or clinical investigation subject administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment) will not be collected.', 'eventGroups': [{'id': 'EG000', 'title': 'Enteral Nutrition + Parenteral Nutrition', 'description': 'Enteral nutrition with the addition of parenteral supplementation (Olimel 5.7%E/N9E).\n\nOlimel (5.7%E / N9E): OLIMEL(Amino Acids, Dextrose, Lipids, with / without Electrolytes) is indicated for parenteral nutrition for adults when oral or enteral nutrition is impossible, insufficient or contraindicated.', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Enteral Nutrition Only', 'description': 'Enteral nutrition only - no intervention', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Calorie & Protein Intake 7 Days Post Randomization', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'EN Only', 'description': 'Enteral nutrition no intervention'}, {'id': 'OG001', 'title': 'Enteral Nutrition + Parenteral Nutrition', 'description': 'Enteral nutrition with the addition of parenteral supplementation (Olimel 5.7%E/N9E).\n\nOlimel (5.7%E / N9E): OLIMEL(Amino Acids, Dextrose, Lipids, with / without Electrolytes) is indicated for parenteral nutrition for adults when oral or enteral nutrition is impossible, insufficient or contraindicated.'}], 'classes': [{'title': 'calories in first 7 days', 'categories': [{'measurements': [{'value': '69', 'spread': '28', 'groupId': 'OG000'}, {'value': '95', 'spread': '13', 'groupId': 'OG001'}]}]}, {'title': 'protein in first 7 days', 'categories': [{'measurements': [{'value': '64', 'spread': '26', 'groupId': 'OG000'}, {'value': '86', 'spread': '16', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '7 days post randomization', 'description': 'Amount of calories \\& protein received as a percentage of prescribed.', 'unitOfMeasure': 'percentage of prescribed', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ICU patients'}, {'type': 'SECONDARY', 'title': '6 Month Mortality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Enteral Nutrition Only', 'description': 'Enteral nutrition no intervention'}, {'id': 'OG001', 'title': 'Enteral Nutrition + Parenteral Nutrition', 'description': 'Enteral nutrition with the addition of parenteral supplementation (Olimel 5.7%E/N9E).\n\nOlimel (5.7%E / N9E): OLIMEL(Amino Acids, Dextrose, Lipids, with / without Electrolytes) is indicated for parenteral nutrition for adults when oral or enteral nutrition is impossible, insufficient or contraindicated.'}], 'classes': [{'categories': [{'measurements': [{'value': '27.5', 'groupId': 'OG000'}, {'value': '29.5', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': '6 months', 'description': 'Kaplan-Meier estimate.', 'unitOfMeasure': 'percentage of participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'ICU Mortality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Enteral Nutrition Only', 'description': 'Enteral nutrition only - no intervention'}, {'id': 'OG001', 'title': 'Enteral Nutrition + Parenteral Nutrition', 'description': 'Enteral nutrition with the addition of parenteral supplementation (Olimel 5.7%E/N9E).\n\nOlimel (5.7%E / N9E): OLIMEL(Amino Acids, Dextrose, Lipids, with / without Electrolytes) is indicated for parenteral nutrition for adults when oral or enteral nutrition is impossible, insufficient or contraindicated.'}], 'classes': [{'categories': [{'measurements': [{'value': '13', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '6 months', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Hospital Mortality', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Enteral Nutrition Only', 'description': 'Enteral nutrition only - no intervention'}, {'id': 'OG001', 'title': 'Enteral Nutrition + Parenteral Nutrition', 'description': 'Enteral nutrition with the addition of parenteral supplementation (Olimel 5.7%E/N9E).\n\nOlimel (5.7%E / N9E): OLIMEL(Amino Acids, Dextrose, Lipids, with / without Electrolytes) is indicated for parenteral nutrition for adults when oral or enteral nutrition is impossible, insufficient or contraindicated.'}], 'classes': [{'categories': [{'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '6 months', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Duration of ICU Stay', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Enteral Nutrition Only', 'description': 'Enteral nutrition only - no intervention'}, {'id': 'OG001', 'title': 'Enteral Nutrition + Parenteral Nutrition', 'description': 'Enteral nutrition with the addition of parenteral supplementation (Olimel 5.7%E/N9E).\n\nOlimel (5.7%E / N9E): OLIMEL(Amino Acids, Dextrose, Lipids, with / without Electrolytes) is indicated for parenteral nutrition for adults when oral or enteral nutrition is impossible, insufficient or contraindicated.'}], 'classes': [{'categories': [{'measurements': [{'value': '12.6', 'groupId': 'OG000', 'lowerLimit': '8.1', 'upperLimit': '18.7'}, {'value': '12.8', 'groupId': 'OG001', 'lowerLimit': '7.9', 'upperLimit': '17.8'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '6 months', 'unitOfMeasure': 'days', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Duration of Hospital Stay', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Enteral Nutrition Only', 'description': 'Enteral nutrition only - no intervention'}, {'id': 'OG001', 'title': 'Enteral Nutrition + Parenteral Nutrition', 'description': 'Enteral nutrition with the addition of parenteral supplementation (Olimel 5.7%E/N9E).\n\nOlimel (5.7%E / N9E): OLIMEL(Amino Acids, Dextrose, Lipids, with / without Electrolytes) is indicated for parenteral nutrition for adults when oral or enteral nutrition is impossible, insufficient or contraindicated.'}], 'classes': [{'categories': [{'measurements': [{'value': '24', 'groupId': 'OG000', 'lowerLimit': '16.6', 'upperLimit': '38.9'}, {'value': '23.5', 'groupId': 'OG001', 'lowerLimit': '17.5', 'upperLimit': '34.7'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '6 months', 'unitOfMeasure': 'days', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Duration of Mechanical Ventilation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Enteral Nutrition Only', 'description': 'Enteral nutrition only - no intervention'}, {'id': 'OG001', 'title': 'Enteral Nutrition + Parenteral Nutrition', 'description': 'Enteral nutrition with the addition of parenteral supplementation (Olimel 5.7%E/N9E).\n\nOlimel (5.7%E / N9E): OLIMEL(Amino Acids, Dextrose, Lipids, with / without Electrolytes) is indicated for parenteral nutrition for adults when oral or enteral nutrition is impossible, insufficient or contraindicated.'}], 'classes': [{'categories': [{'measurements': [{'value': '8.3', 'groupId': 'OG000', 'lowerLimit': '3.8', 'upperLimit': '13.3'}, {'value': '6.5', 'groupId': 'OG001', 'lowerLimit': '3.9', 'upperLimit': '14.1'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': '6 months', 'unitOfMeasure': 'days', 'dispersionType': 'Inter-Quartile Range', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Development of ICU-acquired Infections', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Enteral Nutrition Only', 'description': 'Enteral nutrition only - no intervention'}, {'id': 'OG001', 'title': 'Enteral Nutrition + Parenteral Nutrition', 'description': 'Enteral nutrition with the addition of parenteral supplementation (Olimel 5.7%E/N9E).\n\nOlimel (5.7%E / N9E): OLIMEL(Amino Acids, Dextrose, Lipids, with / without Electrolytes) is indicated for parenteral nutrition for adults when oral or enteral nutrition is impossible, insufficient or contraindicated.'}], 'classes': [{'categories': [{'measurements': [{'value': '23', 'groupId': 'OG000'}, {'value': '14', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'ICU discharge', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'SF36-Physical Functioning Domain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Enteral Nutrition Only', 'description': 'Enteral Nutrition only-no intervention'}, {'id': 'OG001', 'title': 'Enteral Nutrition + Parenteral Nutrition', 'description': 'Enteral nutrition with the addition of parenteral supplementation (Olimel 5.7%E/N9E).\n\nOlimel (5.7%E / N9E): OLIMEL(Amino Acids, Dextrose, Lipids, with / without Electrolytes) is indicated for parenteral nutrition for adults when oral or enteral nutrition is impossible, insufficient or contraindicated.'}], 'classes': [{'categories': [{'measurements': [{'value': '39.4', 'spread': '34.3', 'groupId': 'OG000'}, {'value': '34.8', 'spread': '31.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3 months', 'description': 'The SF-36 physical function domain ranges from 0-100. Higher scores indicate better outcome.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'SF-36 Physical Functioning Domain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Enteral Nutrition Only', 'description': 'Enteral nutrition only - no intervention'}, {'id': 'OG001', 'title': 'Enteral Nutrition + Parenteral Nutrition', 'description': 'Enteral nutrition with the addition of parenteral supplementation (Olimel 5.7%E/N9E).\n\nOlimel (5.7%E / N9E): OLIMEL(Amino Acids, Dextrose, Lipids, with / without Electrolytes) is indicated for parenteral nutrition for adults when oral or enteral nutrition is impossible, insufficient or contraindicated.'}], 'classes': [{'categories': [{'measurements': [{'value': '39.3', 'spread': '34', 'groupId': 'OG000'}, {'value': '50.8', 'spread': '36.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '6 months', 'description': 'The SF-36 physical function domain ranges from 0-100. Higher scores indicate better outcome.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Functional Status at Hospital Discharge', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Enteral Nutrition Only', 'description': 'Enteral nutrition only - no intervention'}, {'id': 'OG001', 'title': 'Enteral Nutrition + Parenteral Nutrition', 'description': 'Enteral nutrition with the addition of parenteral supplementation (Olimel 5.7%E/N9E).\n\nOlimel (5.7%E / N9E): OLIMEL(Amino Acids, Dextrose, Lipids, with / without Electrolytes) is indicated for parenteral nutrition for adults when oral or enteral nutrition is impossible, insufficient or contraindicated.'}], 'classes': [{'title': 'hand grip', 'categories': [{'title': 'Pt died', 'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}, {'title': 'Unable to do', 'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}, {'title': 'Refused to do', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}, {'title': 'Done', 'measurements': [{'value': '22', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}, {'title': 'Missed', 'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '12', 'groupId': 'OG001'}]}, {'title': 'Unknown reason', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}, {'title': 'use ICU', 'measurements': [{'value': '2', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}]}, {'title': '6min walk test', 'categories': [{'title': 'Pt died', 'measurements': [{'value': '17', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}, {'title': 'Unable to do', 'measurements': [{'value': '31', 'groupId': 'OG000'}, {'value': '20', 'groupId': 'OG001'}]}, {'title': 'Refused to do', 'measurements': [{'value': '3', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}, {'title': 'Done', 'measurements': [{'value': '9', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}, {'title': 'Missed', 'measurements': [{'value': '12', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}, {'title': 'Unknown reason', 'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '3', 'groupId': 'OG001'}]}, {'title': 'use ICU', 'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'hospital discharge', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Calorie & Protein Intake in First 27 Days', 'denoms': [{'units': 'Participants', 'counts': [{'value': '71', 'groupId': 'OG000'}, {'value': '49', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'EN Only', 'description': 'Enteral nutrition no intervention'}, {'id': 'OG001', 'title': 'Enteral Nutrition + Parenteral Nutrition', 'description': 'Enteral nutrition with the addition of parenteral supplementation (Olimel 5.7%E/N9E).\n\nOlimel (5.7%E / N9E): OLIMEL(Amino Acids, Dextrose, Lipids, with / without Electrolytes) is indicated for parenteral nutrition for adults when oral or enteral nutrition is impossible, insufficient or contraindicated.'}], 'classes': [{'title': 'calories in first 27 days', 'categories': [{'measurements': [{'value': '72', 'spread': '25', 'groupId': 'OG000'}, {'value': '90', 'spread': '16', 'groupId': 'OG001'}]}]}, {'title': 'protein in first 27 days', 'categories': [{'measurements': [{'value': '68', 'spread': '25', 'groupId': 'OG000'}, {'value': '82', 'spread': '19', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'first 27 days', 'description': 'Amount of calories \\& protein received as a percentage of prescribed.', 'unitOfMeasure': 'percentage of prescribed', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'ICU patients'}, {'type': 'SECONDARY', 'title': 'SF36 Role Physical Domain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Enteral Nutrition Only', 'description': 'Enteral Nutrition only-no intervention'}, {'id': 'OG001', 'title': 'Enteral Nutrition + Parenteral Nutrition', 'description': 'Enteral nutrition with the addition of parenteral supplementation (Olimel 5.7%E/N9E).\n\nOlimel (5.7%E / N9E): OLIMEL(Amino Acids, Dextrose, Lipids, with / without Electrolytes) is indicated for parenteral nutrition for adults when oral or enteral nutrition is impossible, insufficient or contraindicated.'}], 'classes': [{'categories': [{'measurements': [{'value': '30.2', 'spread': '31.8', 'groupId': 'OG000'}, {'value': '32.8', 'spread': '32.6', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3 months', 'description': 'The SF-36 role physical function domain ranges from 0-100. Higher scores indicate better outcome.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'SF36 Pain Index Domain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Enteral Nutrition Only', 'description': 'Enteral Nutrition only-no intervention'}, {'id': 'OG001', 'title': 'Enteral Nutrition + Parenteral Nutrition', 'description': 'Enteral nutrition with the addition of parenteral supplementation (Olimel 5.7%E/N9E).\n\nOlimel (5.7%E / N9E): OLIMEL(Amino Acids, Dextrose, Lipids, with / without Electrolytes) is indicated for parenteral nutrition for adults when oral or enteral nutrition is impossible, insufficient or contraindicated.'}], 'classes': [{'categories': [{'measurements': [{'value': '59.1', 'spread': '28.8', 'groupId': 'OG000'}, {'value': '66.4', 'spread': '27.3', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3 months', 'description': 'The SF-36 pain index domain ranges from 0-100. Higher scores indicate better outcome.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'SF36 General Health Perceptions Domain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Enteral Nutrition Only', 'description': 'Enteral Nutrition only-no intervention'}, {'id': 'OG001', 'title': 'Enteral Nutrition + Parenteral Nutrition', 'description': 'Enteral nutrition with the addition of parenteral supplementation (Olimel 5.7%E/N9E).\n\nOlimel (5.7%E / N9E): OLIMEL(Amino Acids, Dextrose, Lipids, with / without Electrolytes) is indicated for parenteral nutrition for adults when oral or enteral nutrition is impossible, insufficient or contraindicated.'}], 'classes': [{'categories': [{'measurements': [{'value': '61.2', 'spread': '18.3', 'groupId': 'OG000'}, {'value': '49.5', 'spread': '24.3', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3 months', 'description': 'The SF-36 general health perceptions domain ranges from 0-100. Higher scores indicate better outcome.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'SF36 Vitality Domain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Enteral Nutrition Only', 'description': 'Enteral Nutrition only-no intervention'}, {'id': 'OG001', 'title': 'Enteral Nutrition + Parenteral Nutrition', 'description': 'Enteral nutrition with the addition of parenteral supplementation (Olimel 5.7%E/N9E).\n\nOlimel (5.7%E / N9E): OLIMEL(Amino Acids, Dextrose, Lipids, with / without Electrolytes) is indicated for parenteral nutrition for adults when oral or enteral nutrition is impossible, insufficient or contraindicated.'}], 'classes': [{'categories': [{'measurements': [{'value': '52.8', 'spread': '21.4', 'groupId': 'OG000'}, {'value': '51', 'spread': '21.7', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3 months', 'description': 'The SF-36 vitality domain ranges from 0-100. Higher scores indicate better outcome.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'SF36 Social Functioning Domain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Enteral Nutrition Only', 'description': 'Enteral Nutrition only-no intervention'}, {'id': 'OG001', 'title': 'Enteral Nutrition + Parenteral Nutrition', 'description': 'Enteral nutrition with the addition of parenteral supplementation (Olimel 5.7%E/N9E).\n\nOlimel (5.7%E / N9E): OLIMEL(Amino Acids, Dextrose, Lipids, with / without Electrolytes) is indicated for parenteral nutrition for adults when oral or enteral nutrition is impossible, insufficient or contraindicated.'}], 'classes': [{'categories': [{'measurements': [{'value': '60.4', 'spread': '31.8', 'groupId': 'OG000'}, {'value': '56.5', 'spread': '28.2', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3 months', 'description': 'The SF-36 social functioning domain ranges from 0-100. Higher scores indicate better outcome.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'SF36 Role-emotional Domain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Enteral Nutrition Only', 'description': 'Enteral Nutrition only-no intervention'}, {'id': 'OG001', 'title': 'Enteral Nutrition + Parenteral Nutrition', 'description': 'Enteral nutrition with the addition of parenteral supplementation (Olimel 5.7%E/N9E).\n\nOlimel (5.7%E / N9E): OLIMEL(Amino Acids, Dextrose, Lipids, with / without Electrolytes) is indicated for parenteral nutrition for adults when oral or enteral nutrition is impossible, insufficient or contraindicated.'}], 'classes': [{'categories': [{'measurements': [{'value': '63.2', 'spread': '34.6', 'groupId': 'OG000'}, {'value': '65.3', 'spread': '34.4', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3 months', 'description': 'The SF-36 role-emotion domain ranges from 0-100. Higher scores indicate better outcome.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'SF36 Mental Health Index Domain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Enteral Nutrition Only', 'description': 'Enteral Nutrition only-no intervention'}, {'id': 'OG001', 'title': 'Enteral Nutrition + Parenteral Nutrition', 'description': 'Enteral nutrition with the addition of parenteral supplementation (Olimel 5.7%E/N9E).\n\nOlimel (5.7%E / N9E): OLIMEL(Amino Acids, Dextrose, Lipids, with / without Electrolytes) is indicated for parenteral nutrition for adults when oral or enteral nutrition is impossible, insufficient or contraindicated.'}], 'classes': [{'categories': [{'measurements': [{'value': '72.9', 'spread': '18.7', 'groupId': 'OG000'}, {'value': '76.1', 'spread': '18.5', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3 months', 'description': 'The SF-36 mental health index domain ranges from 0-100. Higher scores indicate better outcome.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'SF36 Standardized Physical Component Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'OG000'}, {'value': '52', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Enteral Nutrition Only', 'description': 'Enteral Nutrition only-no intervention'}, {'id': 'OG001', 'title': 'Enteral Nutrition + Parenteral Nutrition', 'description': 'Enteral nutrition with the addition of parenteral supplementation (Olimel 5.7%E/N9E).\n\nOlimel (5.7%E / N9E): OLIMEL(Amino Acids, Dextrose, Lipids, with / without Electrolytes) is indicated for parenteral nutrition for adults when oral or enteral nutrition is impossible, insufficient or contraindicated.'}], 'classes': [{'categories': [{'measurements': [{'value': '35.3', 'spread': '10.8', 'groupId': 'OG000'}, {'value': '33.3', 'spread': '10.1', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '3 months', 'description': 'The SF36 Standardized Physical Component Scale has been scaled to have a mean of zero and standard deviation of 10 in a general US population. 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Higher scores indicate better outcome.'}, {'measure': 'SF-36 Physical Functioning Domain', 'timeFrame': '6 months', 'description': 'The SF-36 physical function domain ranges from 0-100. Higher scores indicate better outcome.'}, {'measure': 'Functional Status at Hospital Discharge', 'timeFrame': 'hospital discharge'}, {'measure': 'SF36 Role Physical Domain', 'timeFrame': '3 months', 'description': 'The SF-36 role physical function domain ranges from 0-100. Higher scores indicate better outcome.'}, {'measure': 'SF36 Pain Index Domain', 'timeFrame': '3 months', 'description': 'The SF-36 pain index domain ranges from 0-100. Higher scores indicate better outcome.'}, {'measure': 'SF36 General Health Perceptions Domain', 'timeFrame': '3 months', 'description': 'The SF-36 general health perceptions domain ranges from 0-100. Higher scores indicate better outcome.'}, {'measure': 'SF36 Vitality Domain', 'timeFrame': '3 months', 'description': 'The SF-36 vitality domain ranges from 0-100. Higher scores indicate better outcome.'}, {'measure': 'SF36 Social Functioning Domain', 'timeFrame': '3 months', 'description': 'The SF-36 social functioning domain ranges from 0-100. Higher scores indicate better outcome.'}, {'measure': 'SF36 Role-emotional Domain', 'timeFrame': '3 months', 'description': 'The SF-36 role-emotion domain ranges from 0-100. Higher scores indicate better outcome.'}, {'measure': 'SF36 Mental Health Index Domain', 'timeFrame': '3 months', 'description': 'The SF-36 mental health index domain ranges from 0-100. Higher scores indicate better outcome.'}, {'measure': 'SF36 Standardized Physical Component Scale', 'timeFrame': '3 months', 'description': 'The SF36 Standardized Physical Component Scale has been scaled to have a mean of zero and standard deviation of 10 in a general US population. Higher scores indicate better HRQoL.'}, {'measure': 'SF36 Standardized Mental Component Scale', 'timeFrame': '3 months', 'description': 'The SF36 Standardized Mental Component Scale has been scaled to have a mean of zero and standard deviation of 10 in a general US population. Higher scores indicate better HRQoL.'}, {'measure': 'SF-36 Role-physical Domain', 'timeFrame': '6 months', 'description': 'The SF-36 mental health index domain ranges from 0-100. Higher scores indicate better outcome.'}, {'measure': 'SF-36 Pain Index Domain', 'timeFrame': '6 months', 'description': 'The SF-36 mental health index domain ranges from 0-100. Higher scores indicate better outcome.'}, {'measure': 'SF-36 General Health Perceptions Domain', 'timeFrame': '6 months', 'description': 'The SF-36 general health perceptions domain ranges from 0-100. Higher scores indicate better outcome.'}, {'measure': 'SF-36 Vitality Domain', 'timeFrame': '6 months', 'description': 'The SF-36 vitality domain ranges from 0-100. Higher scores indicate better outcome.'}, {'measure': 'SF-36 Social Functioning Domain', 'timeFrame': '6 months', 'description': 'The SF-36 social functioning domain ranges from 0-100. Higher scores indicate better outcome.'}, {'measure': 'SF-36 Role-emotional Domain', 'timeFrame': '6 months', 'description': 'The SF-36 role-emotional domain ranges from 0-100. Higher scores indicate better outcome.'}, {'measure': 'SF-36 Mental Health Index Domain', 'timeFrame': '6 months', 'description': 'The SF-36 mental health index domain ranges from 0-100. Higher scores indicate better outcome.'}, {'measure': 'SF-36 Standardized Physical Component Scale', 'timeFrame': '6 months', 'description': 'The SF36 Standardized Physical Component Scale has been scaled to have a mean of zero and standard deviation of 10 in a general US population. Higher scores indicate better HRQoL.'}, {'measure': 'SF-36 Standardized Mental Component Scale', 'timeFrame': '6 months', 'description': 'The SF36 Standardized mental Component Scale has been scaled to have a mean of zero and standard deviation of 10 in a general US population. Higher scores indicate better HRQoL.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Randomized trial', 'Parental nutrition', 'Enteral nutrition', 'Intensive care unit', 'BMI < 25 or ≥ 35'], 'conditions': ['Critical Illness', 'Acute Respiratory Failure']}, 'referencesModule': {'references': [{'pmid': '19572118', 'type': 'BACKGROUND', 'citation': 'Alberda C, Gramlich L, Jones N, Jeejeebhoy K, Day AG, Dhaliwal R, Heyland DK. The relationship between nutritional intake and clinical outcomes in critically ill patients: results of an international multicenter observational study. Intensive Care Med. 2009 Oct;35(10):1728-37. doi: 10.1007/s00134-009-1567-4. Epub 2009 Jul 2.'}, {'pmid': '15899538', 'type': 'BACKGROUND', 'citation': 'Villet S, Chiolero RL, Bollmann MD, Revelly JP, Cayeux R N MC, Delarue J, Berger MM. Negative impact of hypocaloric feeding and energy balance on clinical outcome in ICU patients. Clin Nutr. 2005 Aug;24(4):502-9. doi: 10.1016/j.clnu.2005.03.006.'}, {'pmid': '12853537', 'type': 'BACKGROUND', 'citation': 'Krishnan JA, Parce PB, Martinez A, Diette GB, Brower RG. Caloric intake in medical ICU patients: consistency of care with guidelines and relationship to clinical outcomes. Chest. 2003 Jul;124(1):297-305. doi: 10.1378/chest.124.1.297.'}, {'pmid': '17324665', 'type': 'BACKGROUND', 'citation': 'Hise ME, Halterman K, Gajewski BJ, Parkhurst M, Moncure M, Brown JC. Feeding practices of severely ill intensive care unit patients: an evaluation of energy sources and clinical outcomes. J Am Diet Assoc. 2007 Mar;107(3):458-65. doi: 10.1016/j.jada.2006.12.012.'}, {'pmid': '15185069', 'type': 'BACKGROUND', 'citation': 'Dhaliwal R, Jurewitsch B, Harrietha D, Heyland DK. Combination enteral and parenteral nutrition in critically ill patients: harmful or beneficial? A systematic review of the evidence. Intensive Care Med. 2004 Aug;30(8):1666-71. doi: 10.1007/s00134-004-2345-y. Epub 2004 Jun 8.'}, {'pmid': '28599676', 'type': 'DERIVED', 'citation': 'Wischmeyer PE, Hasselmann M, Kummerlen C, Kozar R, Kutsogiannis DJ, Karvellas CJ, Besecker B, Evans DK, Preiser JC, Gramlich L, Jeejeebhoy K, Dhaliwal R, Jiang X, Day AG, Heyland DK. A randomized trial of supplemental parenteral nutrition in underweight and overweight critically ill patients: the TOP-UP pilot trial. Crit Care. 2017 Jun 9;21(1):142. doi: 10.1186/s13054-017-1736-8.'}]}, 'descriptionModule': {'briefSummary': 'The specific aim of the proposed study is to conduct a pilot study involving 160 critically-ill lean and obese patients enrolled at 11 sites in Canada, the United States of America, Belgium and France in order to:\n\nSpecific Aims\n\n* Confirm that we can achieve a clinically significant difference in calorie and protein intake between the two intervention groups.\n* Estimate recruitment rate i.e. number of eligible and enrolled patients per month per site.\n* Evaluate the safety, tolerance, and logistics around providing supplemental PN in the study population in the context of a multicenter trial, e.g.\n\n * To ensure adequate glycemic control in both groups.\n * To ensure that the other metabolic consequences of the feeding strategies are minimized.\n * To establish adequate compliance with study protocols and completion of case report forms\n\nA secondary aim of this pilot study will be:\n\n• To explore the effect of differential effects of calorie and protein delivery on muscle and mass function.', 'detailedDescription': 'Background\n\nCritically ill patients are often hypermetabolic and can rapidly become nutritionally compromised. Malnutrition is prevalent in these patients and has been associated with increased morbidity and mortality. Standard nutrition therapy, i.e. provision of calories, protein and other nutrients consists primarily of enteral nutrition (via a feeding tube into the gastrointestinal tract), parenteral nutrition (via an intravenous tube into the blood), or occasionally a combination of both.\n\nHowever, the provision of nutrition is sub-optimal and the majority of critically-ill patients do not meet nutritional requirements. Recent studies report that average energy intakes of critically ill patients are only 49% to 70% of calculated requirements. Despite repeated, sustained efforts over the past few years, the investigators have not significantly improved the amount of calories delivered via the enteral route. This leads us to conclude that if the investigators are to be successful at increasing the provision of calories and protein to patients at-risk, the investigators will have to supplement the calories via the parenteral route.\n\nCritically ill patients that are at extremes of weight are at a higher nutritional risk and have higher mortality rates. A recent International multicenter observational study of 2772 ICU patients from 165 ICUs showed a significant inverse linear relationship between the odds of mortality and total daily calories received. Increased amounts of calories was most important for the BMI \\< 20 group followed by the BMI 20 -\\< 25 group and BMI \\> 35 group with no benefit of increased calorie intake for patients in the BMI 25 -\\< 35 group. Feeding an additional 1000 kcals almost halved the odds of 60-day mortality in patients with a BMI \\< 25 or \\> 35. Similar results were observed for feeding an additional 30 grams of protein per day.\n\nThus, a prospective randomized trial is warranted to confirm our hypothesis that in patients with a BMI of \\< 25 and those with a BMI \\> 35 increasing the provision of more energy and protein can impact clinical outcomes. The results of this study will serve to answer some fundamental questions with regards to impact of amount of energy and protein delivered to nutritional at-risk ICU patients and will inform current practice.\n\nStudy Intervention:\n\nPatients will be randomized to one of 2 interventions: enteral nutrition alone or enteral nutrition plus parenteral nutrition (supplemental PN group).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Critically ill adult patient (≥ 18 years) admitted to ICU\n* Has acute respiratory failure (ARF) i.e. expected to remain mechanically ventilated for more than 48 hours\n* Expected ICU dependency of 5 or more days\n* On or expected to initiate enteral nutrition within 7 days of ICU admission\n* BMI \\<25 or ≥ 35 based on pre-ICU actual or estimated dry weight\n\nExclusion Criteria:\n\n* \\>72 hours from admission to ICU to time of consent\n* Not expected to survive an additional 48 hrs from screening evaluation\n* A lack of commitment to full aggressive care (anticipated withholding or withdrawing treatments in the first week but isolated DNR acceptable)\n* Patients already receiving PN at screening\n* Absence of All gastrointestinal risk factors, defined as:\n\n 1. High Apache II Score (\\>20)\n 2. On more than 1 vasopressor or increasing doses or vasopressors\n 3. Receiving continuous infusion of narcotics\n 4. High nasogastric/orogastric output (\\>500 mL over 24 hours)\n 5. Recent surgery involving esophagus, stomach, or small bowel OR peritoneal contamination with bowel contents\n 6. Pancreatitis\n 7. Multiple gastrointestinal investigations\n 8. Recent history of diarrhea/C. Difficile\n 9. Surgical patients with future surgeries planned\n 10. Ruptured or dissected abdominal aortic aneurysm\n* Patients admitted with diabetic ketoacidosis or non-ketotic hyperosmolar coma\n* Pregnant or lactating patients\n* Patients with clinical fulminant hepatic failure\n* Patients with Cirrhosis Child's Class C Liver Disease (except those on a transplant list or transplantable)\n* Dedicated port of central line not available\n* Known allergy to study nutrients (soy, eggs or olive products)\n* Enrolment in another industry sponsored ICU intervention study"}, 'identificationModule': {'nctId': 'NCT01206166', 'acronym': 'TOP-UP', 'briefTitle': 'Trial of Supplemental Parenteral Nutrition in Under and Over Weight Critically Ill Patients (TOP-UP)', 'organization': {'class': 'OTHER', 'fullName': 'Clinical Evaluation Research Unit at Kingston General Hospital'}, 'officialTitle': 'A Randomized Trial of Supplemental Parenteral Nutrition in Under and Over Weight Critically Ill Patients: The TOP UP Trial (Pilot)', 'orgStudyIdInfo': {'id': 'TOP-UP'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Enteral Nutrition + Parenteral Nutrition', 'description': 'Enteral nutrition with the addition of parenteral supplementation (Olimel 5.7%E/N9E).', 'interventionNames': ['Drug: Olimel (5.7%E / N9E)']}, {'type': 'NO_INTERVENTION', 'label': 'Enteral Nutrition Only', 'description': 'Enteral nutrition only - no intervention'}], 'interventions': [{'name': 'Olimel (5.7%E / N9E)', 'type': 'DRUG', 'otherNames': ['Olimel'], 'description': 'OLIMEL(Amino Acids, Dextrose, Lipids, with / without Electrolytes) is indicated for parenteral nutrition for adults when oral or enteral nutrition is impossible, insufficient or contraindicated.', 'armGroupLabels': ['Enteral Nutrition + Parenteral Nutrition']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80045', 'city': 'Boulder', 'state': 'Colorado', 'country': 'United States', 'facility': 'University of Colorado DHSC', 'geoPoint': {'lat': 40.01499, 'lon': -105.27055}}, {'zip': '63110-1093', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Washington University School of Medicine in St. Louis', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '63141', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Mercy Hospital St. Louis', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '44195', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Cleveland Clinic Lerner College of Medicine', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '43221', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'The Ohio State Univsersity Medical Center', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '97239-3098', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Oregon Health & Science University', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'University of Texas Health Science Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': 'B - 1070', 'city': 'Brussels', 'country': 'Belgium', 'facility': 'Erasme University Hospital', 'geoPoint': {'lat': 50.85045, 'lon': 4.34878}}, {'zip': 'T5H 3V9', 'city': 'Edmonton', 'state': 'Alberta', 'country': 'Canada', 'facility': 'Royal Alexandra Hospital', 'geoPoint': {'lat': 53.55014, 'lon': -113.46871}}, {'zip': 'T5H 3V9', 'city': 'Edmonton', 'state': 'Alberta', 'country': 'Canada', 'facility': 'University of Alberta', 'geoPoint': {'lat': 53.55014, 'lon': -113.46871}}, {'zip': 'T6L 5X8', 'city': 'Edmonton', 'state': 'Alberta', 'country': 'Canada', 'facility': 'Grey Nuns Hospital', 'geoPoint': {'lat': 53.55014, 'lon': -113.46871}}, {'zip': 'F - 67091', 'city': 'Strasbourg', 'country': 'France', 'facility': 'Nouvel Hôpital Civil', 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}], 'overallOfficials': [{'name': 'Daren K. Heyland, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Clinical Evaluation Research Unit, Kingston General Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Clinical Evaluation Research Unit at Kingston General Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Baxter Healthcare Corporation', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Director', 'investigatorFullName': 'Daren K. Heyland', 'investigatorAffiliation': 'Clinical Evaluation Research Unit at Kingston General Hospital'}}}}