Enhancing the Anabolic Effect of Perioperative Nutrition With Insulin While Maintaining Normoglycemia

Phase 4UnknownNCT02032953

McGill University Health Centre/Research Institute of the McGill University Health Centre24 enrolled

Overview

The purpose of this study is to find out whether adding insulin after current colorectal cancer surgery promotes making and keeping proteins in the body, and to find out whether or not this effect can be further increased by increasing the amount of protein given.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Colorectal Cancer

Interventions

Travasol (amino acid injection)DIETARY_SUPPLEMENT

an amino acid supplementation infused intravenously containing essential and non-essential amino acids

InsulinDRUG

After the insertion of an arterial catheter and obtaining a baseline arterial blood glucose value, 2 units of insluin will be administered iv followed by an infusion of 2 microunits/kg\*min. Ten minuts after starting the insulin, and when the the blood glucose is\<6 mmol/L, dextrose 20% supplemented with phosphate (30mmol/L) will be infused. Blood glucose levels measured every 15 minutes and the dextrose infusion rate adjusted to maintain arterial glycemia between 4 and 6 mmol/L until end of study.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * American Society of Anesthesiologists class\<3 * age\>18 years * colorectal surgery for non-metastatic colorectal adenocarcinoma including right and left hemicolectomy, transverse, subtotal and total colectomy sigmoid and low anterior resection * ability to give informed consent Exclusion Criteria: * BMI\>30 Kg/meter squared * confirmed diagnosis of diabetes mellitus or a HbA1c\>6.0% * significant cardiorespiratory, hepatic, renal and neurological disease * musculoskeletal or neuromuscular disease * ingestion of drugs known to affect protein, glucose and lipid metabolism (e.g. steroids) * severe anemia (hemoglobin\<10 g/dL * pregnancy * history of severe sciatica, back surgery or other conditions which contraindicate the use of epidural catheters

Locations (1)

McGill University Health Centre (MUHC) - Royal Victoria Hospital

Montreal, Quebec, Canada

Outcomes

Primary Outcomes

Net protein balance

The difference in total body protein after randomization to one of the three treatment arms.

Time frame: 6 hours after surgery

Data from ClinicalTrials.gov

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