Glucose-insulin-potassium Therapy Improves Lactic Acidosis in Liver Transplantation

What Was Tested

This registered not phased trial tested Insulin (regular human).

Lactic acidosis is a common phenomenon occurring during orthotopic liver transplantation (OLT), especially during the anhepatic and early postreperfusion phases.

It had two arms (groups): control group (placebo comparator) and GIK group (experimental).

Saline.

Glucose-Insulin-Potassium(GIK) infusion.

The registry classes the interventions as other.

More on the Plan

Intraoperative metabolic acidosis begins soon after graft reperfusion and persists for several days.

Surgical procedure is a primary source of endogenous lactic acid production, especially visceral ischemia originating from anhepatic stage.

Patients for orthotopic liver transplantation was enrolled and received either GIK or placebo.

GIK or placebo infusion started after anesthesia induction.

Who Took Part

Enrollment: 80 actual participants took part.

It was open to people of any sex.

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

Examples of who could join: Patients who were to undergo OLT.

The full record lists 1 inclusion and 1 exclusion criteria; among the exclusions: diabetes mellitus, hyperkalemia on arrival (k+ \> 5.5 meq/l) and the inability to give informed consent.

How the Study Was Run

Design: randomized, parallel-group and triple-blind.

Because people in this Insulin (regular human) study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

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

Blinding on both sides kept the participants and researchers unaware of who received Insulin (regular human).

Those kept unaware of assignments: participant, investigator and outcomes assessor.

It started in 2016-02 with completion listed for 2017-10.

It ran at 1 site in China.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): degree of lactic acidosis (time frame: up to 1 weeks).

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Insulin (regular human) in 80 people.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

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