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

Not Applicable

Completed

• Conditions: Liver Failure
• Interventions: Drug: Vasopressin; Drug: Normal saline placebo

• Registration Number: NCT00886262
• Lead Sponsor: Medical University of South Carolina

Brief Summary

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

Detailed Description

Renal failure is a common complication of liver disease. Hepatorenal syndrome is caused by a dysfunctional global circulation in the setting of liver disease: Increased flow to the mesenteric circulation is a contributor to decreased blood flow to the kidneys (1). Renal failure often worsens in the perioperative period of liver transplantation since the kidneys are further stressed by reduced flow due to inferior venacava occlusion, decreased blood flow to the kidneys from anesthetics, as well as hypotension from volume shifts, such as when large volumes of ascites are removed. Renal failure is a cause of major morbidity and mortality in patients undergoing liver transplantation.

Vasopressin is a logical choice of therapy in this context as the effects of the drug work to particularly increase renal blood flow and glomerular filtration rate due to the location of specific vasopressin receptors within the renal vasculature. It has been suggested that the use of splanchnic (and systemic) vasoconstrictors such as terlipressin (a vasopressin analog) or alpha-1-adrenoceptor agonists (midodrine or noradrenaline) may improve renal function in patients with type 1 Hepatorenal Syndrome.

Six studies (with only one randomized study in a small series of patients) have shown that terlipressin improves renal function in these patients (2-7). This drug is available in Europe, but not in the United States. However, while anesthesiologists commonly use vasopressin during liver transplantation in the setting of hepatorenal syndrome or vasodilatory shock, the validity of this practice for its effects on renal function and outcomes has not been rigorously studied (8-10). Therefore, the purpose of this study is to evaluate the effects of low-dose vasopressin on intraoperative and perioperative renal function in liver transplant patients.

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.

Study Timeline

• Study Start: 2007-07
• Study First Submitted: 2009-04-21
• Study First Submitted QC: 2009-04-21
• Study First Posted: 2009-04-22
• Primary Completion: 2011-08
• Study Completion: 2011-08
• Results First Submitted: 2018-07-24
• Status Verified: 2018-08
• Results First Submitted QC: 2018-09-21
• Last Update Submitted: 2018-09-21
• Results First Posted: 2018-10-17
• Last Update Posted: 2018-10-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

• > 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

Exclusion Criteria

• < 18 years of age
• renal failure

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Vasopressin	Vasopressin	-
Normal saline placebo	Normal saline placebo	-

Primary Outcome Measures

Name	Time	Method
Change in Creatinine Levels	baseline to 48 hours postop
Change in Urine Output	24 hours to 48 hours postop

Secondary Outcome Measures

Name	Time	Method
Count of Participants Who Needed Diuretics Postoperatively	48 hours
Count of Patient Who Need Vasopressers in the Perioperative Period	48 hours

Trial Locations

Locations (1)

Medical University of South Carolina; 🇺🇸 Charleston, South Carolina, United States