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

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:

Drug Information available for: Dextrose

U.S. FDA Resources

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

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

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):

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. 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. Epub 2010 Apr 7.

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 May 23, 2013