Ignite Creation Date:
2024-05-05 @ 9:25 PM
Last Modification Date:
2024-10-26 @ 10:04 AM
Study NCT ID:
NCT00886262
Status:
COMPLETED
Last Update Posted:
2018-10-17
First Post:
2009-04-21
Brief Title:
Study to Evaluate if the Drug Vasopressin Protects the Kidneys for Patients Undergoing Liver Transplant
Sponsor:
Medical University of South Carolina
Organization:
Medical University of South Carolina
Study Overview
Official Title:
Low Dose Vasopressin for Renal Protection During Liver Transplantation
Status:
COMPLETED
Status Verified Date:
2018-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None