Conventional Fasting Versus Lipid/Carbohydrate Infusion for Coronary Bypass Patients

NCT03033667 | Completed

• 1 other identifier: SMOF
• Study Type: interventional
• Target: 63
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Metabolism Disorder

Keywords

perioperative fasting; free fatty acids; coronary bypass grfting

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (3)

Glucose group (G group)

EXPERIMENTAL

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

Lipid Group (L group)

EXPERIMENTAL

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

Control Group (C group)

EXPERIMENTAL

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

Dietary Supplement: Group C

Interventions

G group DIETARY_SUPPLEMENT

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

Glucose group (G group)

group L 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

Lipid Group (L group)

Group C DIETARY_SUPPLEMENT

Over night fasting with no supplementation

Control Group (C group)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Cairo University: lead

MeSH Terms

Conditions

Metabolic Diseases

Condition Hierarchy (Ancestors)

Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant professor

Study Record Dates

• First Submitted: January 6, 2017
• First Posted: January 27, 2017
• Study Start: September 1, 2014
• Primary Completion: July 1, 2016
• Study Completion: July 1, 2016
• Last Updated: January 27, 2017

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will share