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

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
Emory University
Information provided by:
Medical University of South Carolina
ClinicalTrials.gov Identifier:
NCT00886262
First received: April 21, 2009
Last updated: NA
Last verified: April 2009
History: No changes posted
  Purpose

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


Condition Intervention
Liver Failure
Drug: Vasopressin
Drug: Normal saline placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Low Dose Vasopressin for Renal Protection During Liver Transplantation

Resource links provided by NLM:


Further study details as provided by Medical University of South Carolina:

Primary Outcome Measures:
  • Low dose vasopressin given during liver transplantation prevents renal dysfunction in the perioperative period confirmed by evaluating creatinine postoperatively. [ Time Frame: baseline, 24 hours postop, 48 hours postop ] [ Designated as safety issue: Yes ]
  • Low dose vasopressin given during liver transplantation prevents renal dysfunction in the perioperative period confirmed by evaluating urine output postoperatively [ Time Frame: baseline, 24 hours postop, 48 hours postop ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Low-dose vasopressin given during liver transplantation prevents renal dysfunction in the perioperative period confirmed by evaluating the need for diuretics in the perioperative period. [ Time Frame: 48 hours ] [ Designated as safety issue: Yes ]
  • Low-dose Vasopressin given during liver transplantation prevents renal dysfunction in the perioperative period confirmed by evaluating hemodynamic stability/requirement of additional vasopressors in the perioperative period. [ Time Frame: 48 hours ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 60
Study Start Date: July 2007
Estimated Study Completion Date: January 2010
Estimated Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Vasopressin Drug: Vasopressin
Patients randomly assigned to the experimental arm of the study will receive vasopressin 0.5U/hr IV (20 U vasopressin in 250mL of 0.9% NaCL to infuse at a rate of 6.25mL/hr) via internal jugular catheter. Vasopressin infusion is started at the time of incision and is stopped at the time abdominal closure is completed
Placebo Comparator: Normal saline placebo Drug: Normal saline placebo
Patients randomly assigned to the placebo arm of the study will receive placebo (0.9% NaCl to infuse at a rate of 6.25 mL/hr) via internal jugular catheter

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00886262

Locations
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Sponsors and Collaborators
Medical University of South Carolina
Emory University
Investigators
Principal Investigator: Matthew D McEvoy, MD Medical University of South Carolina
  More Information

Publications:
Csete M. IARS 2007 Review Course Lectures: Anesthesia for Liver Transplantation. Anes Analg 2007; 104:19-24,2007.

Responsible Party: Matthew D. McEvoy MD, Medical University of South Carolina
ClinicalTrials.gov Identifier: NCT00886262     History of Changes
Other Study ID Numbers: Vasopressin HR #17345
Study First Received: April 21, 2009
Last Updated: April 21, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Medical University of South Carolina:
liver transplantation
vasopressin
renal function
hypotension
creatinine
urine output
diuretics
vasopressors
hemodynamic stability

Additional relevant MeSH terms:
Liver Failure
Hepatic Insufficiency
Liver Diseases
Digestive System Diseases
Vasopressins
Arginine Vasopressin
Hemostatics
Coagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions
Vasoconstrictor Agents
Cardiovascular Agents
Antidiuretic Agents
Natriuretic Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on April 15, 2014