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Conventional Fasting Versus Lipid/Carbohydrate Infusion for Coronary Bypass Patients

Primary Purpose

Metabolism Disorder

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
G group
group L
Group C
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Metabolism Disorder focused on measuring perioperative fasting, free fatty acids, coronary bypass grfting

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    Experimental

    Arm Label

    Glucose group (G group)

    Lipid Group (L group)

    Control Group (C group)

    Arm Description

    patients received 500 cc of glucose 10% that containing 50 g of glucose and provides patients with 200 Kcal with 556 mosmoles/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.

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

    Outcomes

    Primary Outcome Measures

    The change in free fatty acids levels and insulin blood levels before and after the infusion of study solution

    Secondary Outcome Measures

    Full Information

    First Posted
    January 6, 2017
    Last Updated
    January 25, 2017
    Sponsor
    Cairo University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03033667
    Brief Title
    Conventional Fasting Versus Lipid/Carbohydrate Infusion for Coronary Bypass Patients
    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 Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    September 2014 (undefined)
    Primary Completion Date
    July 2016 (Actual)
    Study Completion Date
    July 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Cairo University

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Metabolism Disorder
    Keywords
    perioperative fasting, free fatty acids, coronary bypass grfting

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare Provider
    Allocation
    Randomized
    Enrollment
    63 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Glucose group (G group)
    Arm Type
    Experimental
    Arm Description
    patients received 500 cc of glucose 10% that containing 50 g of glucose and provides patients with 200 Kcal with 556 mosmoles/L.
    Arm Title
    Lipid Group (L group)
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Control Group (C group)
    Arm Type
    Experimental
    Arm Description
    patients was fasting overnight from 11 pm till 9 am except for clear fluids that was allowed till 5 am.
    Intervention Type
    Dietary Supplement
    Intervention Name(s)
    G group
    Intervention Description
    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
    Intervention Name(s)
    group L
    Intervention Description
    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
    Intervention Name(s)
    Group C
    Intervention Description
    Over night fasting with no supplementation
    Primary Outcome Measure Information:
    Title
    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

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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

    12. IPD Sharing Statement

    Plan to Share IPD
    Yes

    Learn more about this trial

    Conventional Fasting Versus Lipid/Carbohydrate Infusion for Coronary Bypass Patients

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