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

Liver Function Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00774098
• Other study ID #: SDR-06-012
• Status: Completed
• Phase: N/A
• First received: October 15, 2008
• Last updated: March 31, 2010
• Start date: January 2007
• Est. completion date: September 2009

Study information

• Verified date: March 2010
• Source: McGill University Health Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: September 2009
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Liver Function

Intervention

Drug:
• dextrose 10% (D10W ®) infusion
Started at 8pm the day before surgery until the procedure begins
• hyperinsulinemic normoglycemic clamp
Started as the procedure begins, decreased at the end of the procedure and continued until 16 hours postoperatively

Dietary Supplement:
• 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

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

Locations

Country	Name	City	State
Canada	Royal Victoria Hospital	Montreal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
McGill University Health Center

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative liver function test		Postoperative	No
Secondary	Liver and muscle glycogen, TG, and protein content at beginning and end of the procedure.		Begining + end of the procedure	No
Secondary	Incidence of complications		Postoperative	No