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临床试验/NCT00110201
NCT00110201Unknown3 期

Prophylactic Use of Nesiritide (Brain Natriuretic Peptide, BNP) for the Prevention of Acute Renal Failure in Thoracic Aortic Aneurysm Surgery Patients

Ejaz, Abulate A, MD2 个研究点 分布在 1 个国家目标入组 124 人开始时间: 2005年3月1日最近更新:
适应症
相关药物

试验速览

阶段
3 期
发起方
入组人数
124
试验地点
2
主要终点
Need for dialysis and/or mortality

研究概览

简要总结

The purpose of this trial is to study the use of nesiritide in thoracic aneurysm repair to prevent acute renal failure.

The study hypothesis: Nesiritide, given prophylactically prior to surgery may prevent acute renal failure requiring dialysis and/or decrease mortality.

详细描述

Acute renal failure is a major and serious complication of more than 200,000 cardiovascular surgeries performed on adult Americans annually (www.sts.org). The incidence of acute renal failure (ARF) after cardiac surgery (depending on criteria used to define ARF) is 1-5%, in the absence of preexisting renal dysfunction. The subset of patients with thoracic aortic aneurysm surgery have a higher risk for the development of postoperative ARF (25-40% - ARF defined as doubling of serum creatinine; 13% - ARF defined as requirement for dialysis). This risk is further increased by various peri-operative factors, especially cardiopulmonary bypass time.

The overall postoperative mortality rate for cardiovascular surgery is 2.2%, but is much higher for thoracic aortic aneurysm surgery (8-10% for elective repair, 25-50% for ruptured thoracic aorta aneurysm repair). The major risk factor for thoracic aortic aneurysm surgery related mortality is post-operative ARF requiring dialysis. When thoracic aortic aneurysm surgery is complicated by acute renal failure, the mortality rate worsens to 50%. Thus, identifying ways to prevent acute renal failure may have a major impact on the outcome of cardiovascular surgery. A retrospective study of the use of nesiritide in cardiovascular surgery patients by our group has demonstrated a tendency towards a decreased incidence of renal failure and mortality, when the medication is used prophylactically.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double

入排标准

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

入选标准

  • Age 18 years or older
  • Undergoing thoracic aortic aneurysm surgery
  • Impaired renal function

排除标准

  • Prior history of allergy/adverse reaction to Nesiritide
  • History of any organ transplant
  • Preoperative intra-aortic balloon pump (IABP)
  • Decompensated congestive heart failure (CHF)

结局指标

主要结局

Need for dialysis and/or mortality

次要结局

  • Rise in serum creatinine
  • blood urea nitrogen

研究者

发起方
Ejaz, Abulate A, MD
申办方类型
Indiv

研究点 (2)

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