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临床试验/NCT00886262
NCT00886262已完成不适用

Low Dose Vasopressin for Renal Protection During Liver Transplantation

Medical University of South Carolina1 个研究点 分布在 1 个国家目标入组 18 人开始时间: 2007年7月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
已完成
入组人数
18
试验地点
1
主要终点
Change in Creatinine Levels

研究概览

简要总结

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

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • > 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

排除标准

  • < 18 years of age
  • renal failure

研究组 & 干预措施

Vasopressin

Experimental

干预措施: Vasopressin (Drug)

Normal saline placebo

Placebo Comparator

干预措施: Normal saline placebo (Drug)

结局指标

主要结局

Change in Creatinine Levels

时间窗: baseline to 48 hours postop

Change in Urine Output

时间窗: 24 hours to 48 hours postop

次要结局

  • Count of Patient Who Need Vasopressers in the Perioperative Period(48 hours)
  • Count of Participants Who Needed Diuretics Postoperatively(48 hours)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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