Intraoperative Glucose Control in Liver Transplant

What Was Tested

This registered phase 4 trial tested Insulin (regular human).

It had two arms (groups): Strict Glycemic Control (experimental) and Standard of Care Control (no intervention).

The registry classes the interventions as drug.

More on the Plan

Few studies have investigated the role of strict glycemic control during surgery itself.

Liver transplantation is a good model for studying glucose control as hyperglycemia almost always occurs and the incidence of infection is higher than with other surgical procedures.

The researchers performed a retrospective review of 184 consecutive adult liver recipients in which intra-operative blood glucose levels were measured and treated with insulin.

Who Took Part

The registry lists 100 actual participants took part.

It was open to people of any sex aged from 18 years up to 90 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Male or female patients ≥ 18 years old undergoing liver transplantation. Patients willing and capable of giving written informed consent for study participation.

The full record lists 2 inclusion and 11 exclusion criteria; among the exclusions: multi-organ transplant recipients; patients receiving a liver incompatible with a, b or o blood types; HIV infected patients.

How the Study Was Run

Design: randomized, parallel-group and open-label.

Random assignment meant chance, not the researchers, decided who got Insulin (regular human) and who got the comparison, which limits bias.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Being open-label, the Insulin (regular human) study did not mask who received what.

It started in 2008-07 with completion listed for 2009-09.

It ran at 1 site in United States.

Its stated primary purpose is supportive care.

What Was Measured

The main thing measured (primary outcome): Infection Rates (time frame: 30 days). Number of Participants With One Year Survival Post Transplant (time frame: 12 months).

It also tracked 5 secondary outcomes, for example Hospital Length of Stay, Participants Who Required Postoperative Blood Transfusion Within 3 Days in the ICU, Number of Participants With a Need for Hemodialysis, Number of Participants With Biliary Complications and Number of Participants With Venous Thrombotic Complications.

What This Means in Plain Language

Put simply, this is a phase 4, randomized trial of Insulin (regular human) in 100 people.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the Insulin (regular human) compound page, all human trials.