Conventional Fasting Versus Lipid/Carbohydrate Infusion for Coronary Bypass Patients

NCT ID: NCT03033667

Last Updated: 2017-01-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

63 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-30

Study Completion Date

2016-07-31

Brief Summary

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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

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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.

Conditions

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Metabolism Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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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.

Group Type EXPERIMENTAL

G group

Intervention Type DIETARY_SUPPLEMENT

patients received 500 cc of glucose 10% containing 50 g of glucose proving patients with 200 Kcal with 556 mosmoles/L

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.

Group Type EXPERIMENTAL

group L

Intervention Type DIETARY_SUPPLEMENT

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

Control Group (C group)

patients was fasting overnight from 11 pm till 9 am except for clear fluids that was allowed till 5 am.

Group Type EXPERIMENTAL

Group C

Intervention Type DIETARY_SUPPLEMENT

Over night fasting with no supplementation

Interventions

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G group

patients received 500 cc of glucose 10% containing 50 g of glucose proving patients with 200 Kcal with 556 mosmoles/L

Intervention Type 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

Intervention Type DIETARY_SUPPLEMENT

Group C

Over night fasting with no supplementation

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Hisham Hosny

assistant professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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SMOF

Identifier Type: -

Identifier Source: org_study_id

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