Ignite Creation Date:
2025-12-24 @ 5:08 PM
Ignite Modification Date:
2025-12-27 @ 6:27 PM
Study NCT ID:
NCT03388450
Status:
COMPLETED
Last Update Posted:
2018-01-03
First Post:
2017-12-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Omega-3 Fatty Acid for Critically Ill Patients.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018805', 'term': 'Sepsis'}], 'ancestors': [{'id': 'D007239', 'term': 'Infections'}, {'id': 'D018746', 'term': 'Systemic Inflammatory Response Syndrome'}, {'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D004281', 'term': 'Docosahexaenoic Acids'}, {'id': 'D015525', 'term': 'Fatty Acids, Omega-3'}], 'ancestors': [{'id': 'D004042', 'term': 'Dietary Fats, Unsaturated'}, {'id': 'D004041', 'term': 'Dietary Fats'}, {'id': 'D005223', 'term': 'Fats'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': 'D005231', 'term': 'Fatty Acids, Unsaturated'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D005395', 'term': 'Fish Oils'}, {'id': 'D009821', 'term': 'Oils'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 110}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-01-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-12', 'completionDateStruct': {'date': '2017-11-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-12-24', 'studyFirstSubmitDate': '2017-12-24', 'studyFirstSubmitQcDate': '2017-12-24', 'lastUpdatePostDateStruct': {'date': '2018-01-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-01-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-10-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Organs dysfunction free days.', 'timeFrame': '25 days during ICU stay.', 'description': 'The number of organs dysfunction free days (haemodynamic failure and respiratory failure free days).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Sepsis']}, 'descriptionModule': {'briefSummary': 'Sepsis is the most common reason for intensive care unit (ICU) admission. Sepsis flares up the systemic inflammatory response with its mediators. Sepsis treatment protocols have been established in many centres with immune nutrient as adjuvant treatment. Omega-3 fatty acid and other anti-oxidants formulae have been found to improve sepsis outcome. In most of the studies, immune nutrients were giving parenterally, however, nowadays the preferable route of feeding in critically ill patients is enterally. The present study was done to investigate the effect of enteral Omega-3 fatty acid in septic critically ill patients.', 'detailedDescription': 'A hundred and ten critically ill septic patients were included in the study. Patients were divided into two groups fifty-five patients each. Group A received enteral nutrition supplemented with Omega-3 fatty acid and group B received enteral nutrition without Omega-3. Demographic data, sepsis characteristics, number of patients required invasive ventilation, ventilation days, ICU sequential organ failure assessment score (SOFA), organ failure free-days, haemodynamic failure free-days, ICU stay, ICU and hospital outcomes were recorded.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All septic patients who could receive enteral nutrition were included in the study\n\nExclusion Criteria:\n\n* Patients with end stage liver or renal disease, haemodynamic instability, immunosuppression, gastrointestinal comorbidity, allergic to omega-3, received omega-3 a week prior to ICU admission, patients who expected to live less than 24 hours, and patients who were mechanically ventilated on ICU admission were excluded from the study.'}, 'identificationModule': {'nctId': 'NCT03388450', 'briefTitle': 'Omega-3 Fatty Acid for Critically Ill Patients.', 'organization': {'class': 'OTHER', 'fullName': 'Menoufia University'}, 'officialTitle': 'Effect of Enteral Nutrition With Omega-3 Fatty Acid in Critically Ill Septic Patients.', 'orgStudyIdInfo': {'id': 'MenoufiaU2015/1ICU'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Omega 3', 'description': 'Patients received enteral nutrition supplemented with 1000 mg omega-3.', 'interventionNames': ['Drug: Omega 3']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Patients received enteral nutrition supplemented without 1000 mg omega-3.', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Omega 3', 'type': 'DRUG', 'otherNames': ['Omega 3 fatty acid'], 'description': 'Enteral 1000 mg omega 3 fatty acid.', 'armGroupLabels': ['Omega 3']}, {'name': 'Placebo', 'type': 'DRUG', 'otherNames': ['Placebo group'], 'description': 'Enteral nutrition without omega 3 fatty acid.', 'armGroupLabels': ['Placebo']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Menoufia University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor in anaesthesia, intensive care, and pain medicine.', 'investigatorFullName': 'Dr Ezzeldin Ibrahim', 'investigatorAffiliation': 'Menoufia University'}}}}