Conventional Fasting Versus Lipid/Carbohydrate Infusion for Coronary Bypass Patients

Metabolism Disorder Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03033667
• Other study ID #: SMOF
• Status: Completed
• Phase: N/A
• First received: January 6, 2017
• Last updated: January 25, 2017
• Start date: September 2014
• Est. completion date: July 2016

Study information

• Verified date: January 2017
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 63
• Est. completion date: July 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Metabolic Diseases
• Metabolism Disorder

Intervention

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
• 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
• Group C
Over night fasting with no supplementation

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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