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

This study has been completed.
Sponsor:
Information provided by:
McGill University Health Center
ClinicalTrials.gov Identifier:
NCT00774098
First received: October 15, 2008
Last updated: March 31, 2010
Last verified: March 2010
  Purpose

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.


Condition Intervention
Liver Function
Drug: dextrose 10% (D10W ®) infusion
Drug: hyperinsulinemic normoglycemic clamp
Dietary Supplement: high calorie diet 35 kcal/kg
Drug: Intravenous normal saline (NS 0.9)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Improving Glycogen Liver Content Will Improve Post-operative Liver Function in Patients Undergoing Major Liver Resections

Resource links provided by NLM:


Further study details as provided by McGill University Health Center:

Primary Outcome Measures:
  • Postoperative liver function test [ Time Frame: Postoperative ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Liver and muscle glycogen, TG, and protein content at beginning and end of the procedure. [ Time Frame: Begining + end of the procedure ] [ Designated as safety issue: No ]
  • Incidence of complications [ Time Frame: Postoperative ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: January 2007
Study Completion Date: September 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Control Group
Intravenous normal saline (NS 0.9) started just before induction, and titrated to hemodynamic parameters and urine output
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
Experimental: GICP Drug: dextrose 10% (D10W ®) infusion
Started at 8pm the day before surgery until the procedure begins
Drug: 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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00774098

Locations
Canada, Quebec
Royal Victoria Hospital
Montreal, Quebec, Canada, H3A1A1
Sponsors and Collaborators
McGill University Health Center
  More Information

No publications provided by McGill University Health Center

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr Peter Metrakos, MUHC
ClinicalTrials.gov Identifier: NCT00774098     History of Changes
Other Study ID Numbers: SDR-06-012
Study First Received: October 15, 2008
Last Updated: March 31, 2010
Health Authority: Canada: Health Canada

Keywords provided by McGill University Health Center:
all adult patients (>18 years) planned to undergo a major liver resection

ClinicalTrials.gov processed this record on July 29, 2014