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Conventional Fasting Versus Lipid/Carbohydrate Infusion for Coronary Bypass Patients

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ClinicalTrials.gov Identifier: NCT03033667
Recruitment Status : Completed
First Posted : January 27, 2017
Last Update Posted : January 27, 2017
Sponsor:
Information provided by (Responsible Party):
Hisham Hosny, Cairo University

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Metabolism Disorder Dietary Supplement: G group Dietary Supplement: group L Dietary Supplement: Group C Not Applicable

Detailed Description:

Obese patients scheduled for bypass surgery randomly assigned to three groups:

Group 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.

Group 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.

Group III (Control-group): patients fasted overnight from 11 pm till 9 am except for clear fluids which were allowed till 5 am.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 63 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Prevention
Official Title: 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
Study Start Date : September 2014
Actual Primary Completion Date : July 2016
Actual Study Completion Date : July 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Glucose group (G group)
patients received 500 cc of glucose 10% that containing 50 g of glucose and provides patients with 200 Kcal with 556 mosmoles/L.
Dietary Supplement: G group
patients received 500 cc of glucose 10% containing 50 g of glucose proving patients with 200 Kcal with 556 mosmoles/L

Experimental: Lipid Group (L 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 osmolarity of 380 mosmoles /L.
Dietary Supplement: group L
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

Experimental: Control Group (C group)
patients was fasting overnight from 11 pm till 9 am except for clear fluids that was allowed till 5 am.
Dietary Supplement: Group C
Over night fasting with no supplementation




Primary Outcome Measures :
  1. The change in free fatty acids levels and insulin blood levels before and after the infusion of study solution [ Time Frame: Over an infusion period of 10 hours preoperatively ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Adult 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).

All patients were type 1a World Health Organisation (WHO)/Fredrickson classification of primary hyperlipidemias.

Exclusion Criteria:

  • Patients with diabetes mellitus
  • Patients on fibrates
  • Patients type 1,2b,3,4 and 5 WHO/Fredrickson classification of primary hyperperlipidemias
  • Patients with history of allergic reactions to fish, egg yolk containing foods peanut or soy products
  • Patients with carbohydrate or fat intolerance
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Responsible Party: Hisham Hosny, assistant professor, Cairo University
ClinicalTrials.gov Identifier: NCT03033667    
Other Study ID Numbers: SMOF
First Posted: January 27, 2017    Key Record Dates
Last Update Posted: January 27, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Keywords provided by Hisham Hosny, Cairo University:
perioperative fasting
free fatty acids
coronary bypass grfting
Additional relevant MeSH terms:
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Metabolic Diseases