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

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.

Study Overview

• Status: Completed
• Conditions: Liver Function
• Intervention / Treatment: Drug: Intravenous normal saline (NS 0.9); Drug: dextrose 10% (D10W ®) infusion; Drug: hyperinsulinemic normoglycemic clamp; Dietary supplement: high calorie diet 35 kcal/kg

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Quebec
    • Montreal, Quebec, Canada, H3A1A1
      • Royal Victoria Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Postoperative liver function test	Postoperative

Secondary Outcome Measures

Outcome Measure	Time Frame
Liver and muscle glycogen, TG, and protein content at beginning and end of the procedure.	Begining + end of the procedure
Incidence of complications	Postoperative

Collaborators and Investigators

• Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: January 1, 2007
• Primary Completion (Actual): September 1, 2009
• Study Completion (Actual): September 1, 2009

Study Registration Dates

• First Submitted: October 15, 2008
• First Submitted That Met QC Criteria: October 16, 2008
• First Posted (Estimate): October 17, 2008

Study Record Updates

• Last Update Posted (Estimate): April 1, 2010
• Last Update Submitted That Met QC Criteria: March 31, 2010
• Last Verified: March 1, 2010

More Information

Terms related to this study

• Keywords: all adult patients (>18 years) planned to undergo a major liver resection
• Other Study ID Numbers: SDR-06-012