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CompletedNCT00774098Updated Apr 1, 2010

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

An interventional study of dextrose 10% (D10W ®) infusion and hyperinsulinemic normoglycemic clamp in Liver Function, sponsored by McGill University Health Centre/Research Institute of the McGill University Health Centre. Completed at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2010-04-01.

Sponsored by McGill University Health Centre/Research Institute of the McGill University Health Centre · Not applicable, Interventional, and Supportive care

Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Liver Function

Keywords

  • all adult patients (>18 years) planned to undergo a major liver resection
03

In context

Lead sponsor

McGill University Health Centre/Research Institute of the McGill University Health Centre is the lead sponsor of 415 studies on the registry; 106 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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.
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
60 participants (estimated)

Study arms

  • 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)

  • Experimental
    GICP

    Drug: dextrose 10% (D10W ®) infusion · Drug: hyperinsulinemic normoglycemic clamp · Dietary Supplement: high calorie diet 35 kcal/kg

Interventions

  • Drugdextrose 10% (D10W ®) infusion

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

  • Drughyperinsulinemic normoglycemic clamp

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

  • Dietary supplementhigh 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

  • DrugIntravenous normal saline (NS 0.9)

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

06

What researchers measure

Primary outcomes

  1. Postoperative liver function test

    Time frame: Postoperative

Secondary outcomes

  1. Liver and muscle glycogen, TG, and protein content at beginning and end of the procedure.

    Time frame: Begining + end of the procedure

  2. Incidence of complications

    Time frame: Postoperative

07

Study locations

1 site
  • Royal Victoria Hospital
    Montreal, Quebec H3A1A1, Canada
08

References and documents

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. PubMed 23339047 ↗
  • 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. PubMed 22031518 ↗
  • 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. PubMed 20375299 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 1, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00774098
Lead sponsor
McGill University Health Centre/Research Institute of the McGill University Health Centre
First posted
Oct 17, 2008
Start date
Jan 2007
Primary completion
Sep 2009
Completion
Sep 2009
Last update
Apr 1, 2010

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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