Application of High-dose Insulin Therapy to Improve Liver Function and Regeneration

Condition(s) studied

Investigational drug(s) / intervention(s)

High-Dose Insulin Therapy: A baseline blood glucose value will be obtained. Two units of insulin will be administered IV if the blood glucose is \> mmol/L. An insulin infusion of 0.12 units/kg/hr will be started. Ten minutes after starting the insulin, and when the blood glucose is \< 6 mmol/L, dextrose 20% supplemented with phosphate (30 mmol/L) will be infused. Blood glucose levels will be measured every 15 minutes, and the dextrose infusion rate adjusted to maintain glycemic levels between 4 and 6 mmol/L for a duration of 6 hours. At the end of the 6 hour period, the insulin will be stopped and the dextrose will be weaned off.

Study summary

The primary objective of this interventional study is determine if the future liver remnant can be optimized by improving liver function pre-operatively in patients who are scheduled for major hepatectomy. The main questions it aims to answer are:

1. Does high-dose insulin therapy improve liver function in the pre-operative setting?
2. What is the effect of high-dose insulin therapy on liver function and liver regeneration after a liver venous deprivation (LVD) procedure?
3. What is the relationship between volume hypertrophy and function in the regenerating liver? Participants will receive a 6-hour infusion of insulin and dextrose to maintain a hyperinsulinemic-normoglycemic state in the weeks prior to planned liver surgery to assess its effect on liver function measured by 99m-Tc-Mebrofenin hepatobiliary scintigraphy.

Eligibility

Primary outcome measure(s)

• Liver function improvement after high-dose insulin therapy measured with 99mTc-Mebrofenin Hepatobiliary Scintigraphy (HBS). — Baseline to 24-hours post treatment
  99mTc-Mebrofenin HBS is a diagnostic nuclear medicine imaging procedure used to evaluate liver function by measuring radiotracer uptake and excretion. The outcome will be evaluating a measurable increase in 99mTc-Mebrofenin (measured %/min/meter\^2) from baseline scan to post-treatment scan.
• Liver function improvement after high-dose insulin therapy after LVD measured with 99mTc-Mebrofenin Hepatobiliary Scintigraphy (HBS). — Baseline to 7 days post treatment
  99mTc-Mebrofenin HBS is a diagnostic nuclear medicine imaging procedure used to evaluate liver function by measuring radiotracer uptake and excretion. The outcome will be evaluating a measurable increase in 99mTc-Mebrofenin (measured %/min/meter\^2) from baseline scan to post-treatment scan.
• Liver regeneration improvement after high-dose insulin therapy after LVD measured CT volumetry — Baseline to 7 days post treatment
  The volume of the liver can be measured from liver protocoled CT scans

Trial sites (1)

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