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

Study Overview
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Brief Summary
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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.

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

Conditions
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Liver Function

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


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Control Group<br>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)<br>* Intravenous normal saline (NS 0.9) started just before induction, and titrated to hemodynamic parameters and urine output<br>|
| Experimental: GICP<br> | Drug: dextrose 10% (D10W ®) infusion<br>* Started at 8pm the day before surgery until the procedure begins<br>Drug: hyperinsulinemic normoglycemic clamp<br>* Started as the procedure begins, decreased at the end of the procedure and continued until 16 hours postoperatively<br>Dietary Supplement: high calorie diet 35 kcal/kg<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative liver function test |  | Postoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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all adult patients (>18 years) planned to undergo a major liver resection