Ignite Creation Date:
2025-12-25 @ 12:31 AM
Ignite Modification Date:
2026-02-25 @ 6:44 PM
Study NCT ID:
NCT03033667
Status:
COMPLETED
Last Update Posted:
2017-01-27
First Post:
2017-01-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Conventional Fasting Versus Lipid/Carbohydrate Infusion for Coronary Bypass Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008659', 'term': 'Metabolic Diseases'}], 'ancestors': [{'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 63}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-01', 'completionDateStruct': {'date': '2016-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-01-25', 'studyFirstSubmitDate': '2017-01-06', 'studyFirstSubmitQcDate': '2017-01-25', 'lastUpdatePostDateStruct': {'date': '2017-01-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2017-01-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The change in free fatty acids levels and insulin blood levels before and after the infusion of study solution', 'timeFrame': 'Over an infusion period of 10 hours preoperatively'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['perioperative fasting', 'free fatty acids', 'coronary bypass grfting'], 'conditions': ['Metabolism Disorder']}, 'descriptionModule': {'briefSummary': 'Comparative study between conventional fasting versus overnight infusion of lipid or carbohydrate on free fatty acids and insulin in obese patients undergoing elective first time on-pump coronary artery bypass grafting.', 'detailedDescription': 'Obese patients scheduled for bypass surgery randomly assigned to three groups:\n\nGroup I (Glucose-group): patients received 500 cc of glucose 10% containing 50 g of glucose and providing patients with 200 Kcal with an osmolarity of 556 mosm/L.\n\nGroup II (Lipid-group): patients received 100 cc of lipid solution (soybean 30%, medium chain triglycerides 30%,olive oil 25%,fish oil 15% and 20 mg vitamine E) containing 20 g lipid and provides patients with 200 Kcal with an osmolarity of 380 mosm/L.\n\nGroup III (Control-group): patients fasted overnight from 11 pm till 9 am except for clear fluids which were allowed till 5 am.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nAdult patients (\\> 18 years) with American Society of Anesthesia (ASA) class II-III, BMI 30-40, and New York Heart Association (NYHA) functional capacities I-II, undergoing elective on-pump coronary artery bypass grafting (CABG) using cardiopulmonary bypass (CPB).\n\nAll patients were type 1a World Health Organisation (WHO)/Fredrickson classification of primary hyperlipidemias.\n\nExclusion Criteria:\n\n* Patients with diabetes mellitus\n* Patients on fibrates\n* Patients type 1,2b,3,4 and 5 WHO/Fredrickson classification of primary hyperperlipidemias\n* Patients with history of allergic reactions to fish, egg yolk containing foods peanut or soy products\n* Patients with carbohydrate or fat intolerance'}, 'identificationModule': {'nctId': 'NCT03033667', 'briefTitle': 'Conventional Fasting Versus Lipid/Carbohydrate Infusion for Coronary Bypass Patients', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Comparative Study Between Conventional Fasting Versus Overnight Infusion of Lipid or Carbohydrate on Free Fatty Acid and Insulin in Obese Patients Undergoing Elective First Time On-pump Coronary Artery Bypass Grafting', 'orgStudyIdInfo': {'id': 'SMOF'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Glucose group (G group)', 'description': 'patients received 500 cc of glucose 10% that containing 50 g of glucose and provides patients with 200 Kcal with 556 mosmoles/L.', 'interventionNames': ['Dietary Supplement: G group']}, {'type': 'EXPERIMENTAL', 'label': 'Lipid Group (L group)', 'description': 'patients received 100 cc of lipid solution (soybean 30%, medium chain triglycerides 30%,olive oil 25%,fish oil 15% and 20 mg vitamine E) containing 20 g lipid and provides patients with 200 Kcal with osmolarity of 380 mosmoles /L.', 'interventionNames': ['Dietary Supplement: group L']}, {'type': 'EXPERIMENTAL', 'label': 'Control Group (C group)', 'description': 'patients was fasting overnight from 11 pm till 9 am except for clear fluids that was allowed till 5 am.', 'interventionNames': ['Dietary Supplement: Group C']}], 'interventions': [{'name': 'G group', 'type': 'DIETARY_SUPPLEMENT', 'description': 'patients received 500 cc of glucose 10% containing 50 g of glucose proving patients with 200 Kcal with 556 mosmoles/L', 'armGroupLabels': ['Glucose group (G group)']}, {'name': 'group L', 'type': 'DIETARY_SUPPLEMENT', 'description': 'patients received 100 cc of lipid solution (soybean 30%, medium chain triglycerides 30%,olive oil 25%,fish oil 15% and 20 mg vitamine E) containing 20 g lipid which provided patients with 200 Kcal with osmolarity of 380 mosmoles /L. with a flow rate of infusion of 12.5 cc per hour', 'armGroupLabels': ['Lipid Group (L group)']}, {'name': 'Group C', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Over night fasting with no supplementation', 'armGroupLabels': ['Control Group (C group)']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'assistant professor', 'investigatorFullName': 'Hisham Hosny', 'investigatorAffiliation': 'Cairo University'}}}}