The Anabolic Effect Of Perioperative Nutrition With Insulin In Patients Undergoing CABG

NCT02549443 | Completed DMC

• 1 other identifier: 12-383-SDR
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

This study evaluates whether providing a nutritional intervention in the form of insulin, sugar and protein during and after open-heart surgery will increase the body's protein stores and maintain a normal level of blood sugar. The primary outcome will be Whole body protein balance which will be assessed by isotope tracer kinetics. Protein balance will be calculated as protein synthesis minus protein breakdown with positive values indicating anabolism and negative values catabolism. The preoperative measurements will be performed on the morning before the operation. Postoperative studies will be conducted two hours after surgery in the intensive care unit. Patients will be followed for 12 hours after surgery.

Conditions

Coronary Artery Disease

Keywords

Catabolic response; Amino Acids; Insulin

Outcome Measures

Primary Outcomes (1)

• Change in Whole body protein balance which will be assessed by isotope tracer kinetics.

  Protein balance will be calculated as protein synthesis minus protein breakdown with positive values indicating anabolism and negative values catabolism. Patients will be followed for 12 hours after surgery.

  preoperative (morning before the operation), two hours after surgery in the intensive care unit

Study Arms (3)

Insulin

ACTIVE COMPARATOR

hyperinsulinemic-normoglycemic clamp: an insulin infusion of 5 mU.kg-1.min-1 and a variable continuous infusion of glucose (dextrose 20%) to maintain the blood glucose between 4.0 and 6.0 mmol/L.

Dietary Supplement: Amino acids

Insulin and amino acids

ACTIVE COMPARATOR

hyperinsulinemic-normoglycemic clamp: an insulin infusion of 5 mU.kg-1.min-1 and a variable continuous infusion of glucose (dextrose 20%) to maintain the blood glucose between 4.0 and 6.0 mmol/L. Amino Acids (AA) in amounts to preserve normal AA

Dietary Supplement: Amino acids

Insulin and hyperaminoacidemia

ACTIVE COMPARATOR

hyperinsulinemic-normoglycemic clamp: an insulin infusion of 5 mU.kg-1.min-1 and a variable continuous infusion of glucose (dextrose 20%) to maintain the blood glucose between 4.0 and 6.0 mmol/L. AA in amounts to increase AA plasma concentrations to supra-normal levels (hyperaminoacidemia)

Dietary Supplement: Amino acids

Interventions

Amino acids DIETARY_SUPPLEMENT

AA (Travasol Baxter, Deerfield IL) during and after surgery in an amount equivalent to 20% and 35% of the patient's energy expenditure (EE)

Insulin; Insulin and amino acids; Insulin and hyperaminoacidemia

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients scheduled for elective CABG

You may not qualify if:

• Severe malnutrition (weight loss \>20% in preceeding 3 months, low albumin level \<35 g/L and body mass index \<20 kg/m2), obesity (body mass index \>35 kg/m2), chronic liver disease (cirrhosis, documented chronic viral hepatitis and abnormal liver function tests), left ventricular ejection fraction \<30%, active cancer, dialysis, \<18 years of age.

Sponsors & Collaborators

• McGill University Health Centre/Research Institute of the McGill University Health Centre: lead

Study Sites (1)

McGill University Health Center

Montreal, Quebec, H3A 1A1, Canada

Location

Related Publications (2)

• Omiya K, Sato H, Sato T, Wykes L, Hong M, Hatzakorzian R, Kristof AS, Schricker T. Albumin and fibrinogen kinetics in sepsis: a prospective observational study. Crit Care. 2021 Dec 17;25(1):436. doi: 10.1186/s13054-021-03860-7.

  PMID: 34920728 DERIVED

• Codere-Maruyama T, Schricker T, Shum-Tim D, Wykes L, Nitschmann E, Guichon C, Kristof AS, Hatzakorzian R. Hyperinsulinemic-normoglycemic clamp administered together with amino acids induces anabolism after cardiac surgery. Am J Physiol Regul Integr Comp Physiol. 2016 Dec 1;311(6):R1085-R1092. doi: 10.1152/ajpregu.00334.2016. Epub 2016 Oct 5.

  PMID: 27707724 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease; Insulin Resistance

Interventions

Amino Acids

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Amino Acids, Peptides, and Proteins

Study Officials

• Roupen Hatzakorzian, MD, MSc

  McGill University Health Centre/Research Institute of the McGill University Health Centre

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: June 22, 2015
• First Posted: September 15, 2015
• Study Start: August 1, 2013
• Primary Completion: May 1, 2015
• Study Completion: June 1, 2015
• Last Updated: September 15, 2015

Record last verified: 2015-09

Locations

CA (1)