Study to Evaluate if the Drug Vasopressin Protects the Kidneys for Patients Undergoing Liver Transplant

What Was Tested

This registered not phased trial tested Vasopressin for kidney protection (ckd, diabetic kidney, lupus kidney).

The purpose of this study is evaluate the medication vasopressin for its ability to preserve kidney function in patients undergoing liver transplantation.

It had two arms (groups): Vasopressin (experimental) and Normal saline placebo (placebo comparator).

The registry classes the interventions as drug.

More on the Plan

Renal failure is a common complication of liver disease.

Renal failure is a cause of major morbidity and mortality in patients undergoing liver transplantation.

This drug is available in Europe, but not in the United States.

This study will be a randomized, double-blind controlled trial performed in adult liver transplant patients coming to surgery for chronic liver disease; the major end-points of analyses are renal function tests in the perioperative period.

Who Took Part

18 actual participants took part.

It was open to people of any sex aged from 18 years up to 80 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: \> 18 years of age. Undergoing liver transplant. Ability to provide informed consent. If patient is unable to give informed consent i.e. hepatic encephalopathy, consent may be obtained from the patient's legally authorized representative.

The full record lists 3 inclusion and 2 exclusion criteria; among the exclusions: \< 18 years of age; renal failure.

How the Study Was Run

It was run as a randomized, parallel-group and quadruple-blind study.

Random assignment meant chance, not the researchers, decided who got Vasopressin and who got the comparison, which limits bias.

The Vasopressin group and the comparison group ran side by side rather than switching.

As a double-blind Vasopressin study, the assignments were hidden from both participants and investigators until the end.

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

It started in 2007-07 with completion listed for 2011-08.

It ran at 1 site in United States.

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Change in Creatinine Levels (time frame: baseline to 48 hours postop). Change in Urine Output (time frame: 24 hours to 48 hours postop).

It also tracked 2 secondary outcomes, for example Count of Participants Who Needed Diuretics Postoperatively and Count of Patient Who Need Vasopressers in the Perioperative Period.

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Vasopressin in 18 people with kidney protection (ckd, diabetic kidney, lupus kidney).

Its size is small, so on its own it can only give an early look.

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

More context: the Vasopressin compound page, Kidney protection (CKD, diabetic kidney, lupus kidney) research.