Conventional Fasting Versus Lipid/Carbohydrate Infusion for Coronary Bypass Patients

Not Applicable

Completed

• Conditions: Metabolism Disorder
• Interventions: Dietary Supplement: Group C; Dietary Supplement: G group; Dietary Supplement: group L

• Registration Number: NCT03033667
• Lead Sponsor: 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.

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.

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2014-09
• Primary Completion: 2016-07
• Study Completion: 2016-07
• Status Verified: 2017-01
• Study First Submitted: 2017-01-06
• Study First Submitted QC: 2017-01-25
• Last Update Submitted: 2017-01-25
• Study First Posted: 2017-01-27
• Last Update Posted: 2017-01-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 63

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.

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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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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control Group (C group)	Group C	patients was fasting overnight from 11 pm till 9 am except for clear fluids that was allowed till 5 am.
Glucose group (G 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.
Lipid Group (L group)	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 and provides patients with 200 Kcal with osmolarity of 380 mosmoles /L.

Primary Outcome Measures

Name	Time	Method
The change in free fatty acids levels and insulin blood levels before and after the infusion of study solution	Over an infusion period of 10 hours preoperatively