Improving Glycogen Liver Content Will Improve Post-operative Liver Function in Patients Undergoing Major Liver Resections

NCT ID: NCT00774098

Last Updated: 2010-04-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-01-31

Study Completion Date

2009-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

We would like to study the effect of preserving liver glycogen storage by using intravenous dextrose infusion on postoperative liver function and complications after major liver resections.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Liver Function

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Control Group

Intravenous normal saline (NS 0.9) started just before induction, and titrated to hemodynamic parameters and urine output

Group Type PLACEBO_COMPARATOR

Intravenous normal saline (NS 0.9)

Intervention Type DRUG

Intravenous normal saline (NS 0.9) started just before induction, and titrated to hemodynamic parameters and urine output

GICP

Group Type EXPERIMENTAL

dextrose 10% (D10W ®) infusion

Intervention Type DRUG

Started at 8pm the day before surgery until the procedure begins

hyperinsulinemic normoglycemic clamp

Intervention Type DRUG

Started as the procedure begins, decreased at the end of the procedure and continued until 16 hours postoperatively

high calorie diet 35 kcal/kg

Intervention Type DIETARY_SUPPLEMENT

High Calorie meals start the day before the surgery and are given 5 hours apart. The last meal is given at 7 pm the day before surgery

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

dextrose 10% (D10W ®) infusion

Started at 8pm the day before surgery until the procedure begins

Intervention Type DRUG

hyperinsulinemic normoglycemic clamp

Started as the procedure begins, decreased at the end of the procedure and continued until 16 hours postoperatively

Intervention Type DRUG

high calorie diet 35 kcal/kg

High Calorie meals start the day before the surgery and are given 5 hours apart. The last meal is given at 7 pm the day before surgery

Intervention Type DIETARY_SUPPLEMENT

Intravenous normal saline (NS 0.9)

Intravenous normal saline (NS 0.9) started just before induction, and titrated to hemodynamic parameters and urine output

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* 18 years or older
* planned to undergo a major liver resection at McGill University Health Center (MUHC)

Exclusion Criteria

* patients known with chronic viral liver disease
* uncontrolled or type one diabetes mellitus (DM)
* patients on oral beta-blocker agents
* patients with unresectable disease determined intra-operatively
* patients unable to give consent for the study.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

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

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

MUHC

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Royal Victoria Hospital

Montreal, Quebec, Canada

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Canada

References

Explore related publications, articles, or registry entries linked to this study.

Hassanain M, Metrakos P, Fisette A, Doi SA, Schricker T, Lattermann R, Carvalho G, Wykes L, Molla H, Cianflone K. Randomized clinical trial of the impact of insulin therapy on liver function in patients undergoing major liver resection. Br J Surg. 2013 Apr;100(5):610-8. doi: 10.1002/bjs.9034. Epub 2013 Jan 21.

Reference Type DERIVED
PMID: 23339047 (View on PubMed)

Fisette A, Hassanain M, Metrakos P, Doi SA, Salman A, Schricker T, Lattermann R, Wykes L, Nitschmann E, Smith J, Cianflone K. High-dose insulin therapy reduces postoperative liver dysfunction and complications in liver resection patients through reduced apoptosis and altered inflammation. J Clin Endocrinol Metab. 2012 Jan;97(1):217-26. doi: 10.1210/jc.2011-1598. Epub 2011 Oct 26.

Reference Type DERIVED
PMID: 22031518 (View on PubMed)

Sato H, Lattermann R, Carvalho G, Sato T, Metrakos P, Hassanain M, Matsukawa T, Schricker T. Perioperative glucose and insulin administration while maintaining normoglycemia (GIN therapy) in patients undergoing major liver resection. Anesth Analg. 2010 Jun 1;110(6):1711-8. doi: 10.1213/ANE.0b013e3181d90087. Epub 2010 Apr 7.

Reference Type DERIVED
PMID: 20375299 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

SDR-06-012

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Preoperative Glucocorticoid Use in Major Hepatectomy
NCT01997658 COMPLETED PHASE2/PHASE3