NCT00774098

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2007

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2007

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

October 15, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 17, 2008

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2009

Completed
Last Updated

April 1, 2010

Status Verified

March 1, 2010

Enrollment Period

2.7 years

First QC Date

October 15, 2008

Last Update Submit

March 31, 2010

Conditions

Liver Function

Keywords

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

Outcome Measures

Primary Outcomes (1)

  • Postoperative liver function test

    Postoperative

Secondary Outcomes (2)

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

    Begining + end of the procedure

  • Incidence of complications

    Postoperative

Study Arms (2)

Control Group

PLACEBO COMPARATOR

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)

GICP

EXPERIMENTAL
Drug: dextrose 10% (D10W ®) infusionDrug: hyperinsulinemic normoglycemic clampDietary Supplement: high calorie diet 35 kcal/kg

Interventions

dextrose 10% (D10W ®) infusionDRUG

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

GICP
hyperinsulinemic normoglycemic clampDRUG

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

GICP
high calorie diet 35 kcal/kgDIETARY_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

GICP
Intravenous normal saline (NS 0.9)DRUG

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

Control Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Royal Victoria Hospital

Montreal, Quebec, H3A1A1, Canada

Location

Related Publications (3)

  • 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.

    PMID: 23339047DERIVED

  • 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.

    PMID: 22031518DERIVED

  • 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.

    PMID: 20375299DERIVED

MeSH Terms

Interventions

Glucose

Intervention Hierarchy (Ancestors)

HexosesMonosaccharidesSugarsCarbohydrates

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 15, 2008

First Posted

October 17, 2008

Study Start

January 1, 2007

Primary Completion

September 1, 2009

Study Completion

September 1, 2009

Last Updated

April 1, 2010

Record last verified: 2010-03

Locations

CA(1)