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

NCT ID: NCT02032953

Last Updated: 2023-03-17

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-12-31
• Study Completion Date: 2024-04-30

Brief Summary

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.

Conditions

Colorectal Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Insulin, Travasol (35%) postop

Insulin (hyperinsulinemic-normoglycemic clamp) with Travasol (amino acid supplementation) given from start of surgery to 6 hours after, at an amount of 35% of patient's energy expenditure as measured before surgery, .

Group Type: EXPERIMENTAL

Travasol (amino acid injection)

Intervention Type: DIETARY_SUPPLEMENT

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

Insulin

Intervention Type: DRUG

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.

Insulin, Travasol (20%) postop

Insulin (hyperinsulinemic-normoglycemic clamp) with Travasol (amino acid infusion), given from start of surgery to 6 hours after, at an amount of 20% of patient's energy expenditure as measured before surgery.

Group Type: EXPERIMENTAL

Travasol (amino acid injection)

Intervention Type: DIETARY_SUPPLEMENT

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

Insulin

Intervention Type: DRUG

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.

Insulin, no protein after surgery

Insulin (hyperinsulinemic-normoglycemic clamp, an insulin infusion between 2 and 5 microunits/kg with glucose at a variable rated titrated to maintain normoglycemia, blood glucose 4-6 mmol/L) with no protein supplementation from start of surgery to 6 hours after.

Group Type: PLACEBO_COMPARATOR

Insulin

Intervention Type: DRUG

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.

Interventions

Travasol (amino acid injection)

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

Intervention Type: DIETARY_SUPPLEMENT

Insulin

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.

Intervention Type: DRUG

Other Intervention Names

Travasol; HNC; Hyperinsulinemic-normoglycemic clamp

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Canadian Institutes of Health Research (CIHR)

OTHER_GOV

Sponsor Role: collaborator

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

OTHER

Sponsor Role: lead

Responsible Party

Thomas Schricker

Chief of Anesthesia

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Thomas Schricker, MD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

McGill University Health Centre (MUHC) - Royal Victoria Hospital

Montreal, Quebec, Canada

Countries

Canada

References

Schricker T, Meterissian S, Wykes L, Eberhart L, Lattermann R, Carli F. Postoperative protein sparing with epidural analgesia and hypocaloric dextrose. Ann Surg. 2004 Nov;240(5):916-21. doi: 10.1097/01.sla.0000143249.93856.66.

Reference Type: BACKGROUND

PMID: 15492576 (View on PubMed)

Schricker T, Wykes L, Carli F. Epidural blockade improves substrate utilization after surgery. Am J Physiol Endocrinol Metab. 2000 Sep;279(3):E646-53. doi: 10.1152/ajpendo.2000.279.3.E646.

Reference Type: RESULT

PMID: 10950834 (View on PubMed)

Bellon F, Sola I, Gimenez-Perez G, Hernandez M, Metzendorf MI, Rubinat E, Mauricio D. Perioperative glycaemic control for people with diabetes undergoing surgery. Cochrane Database Syst Rev. 2023 Aug 1;8(8):CD007315. doi: 10.1002/14651858.CD007315.pub3.

Reference Type: DERIVED

PMID: 37526194 (View on PubMed)

Other Identifiers

12-459-GEN

Identifier Type: -

Identifier Source: org_study_id