The Use of Nesiritide in Thoracic Aneurysm Repair to Prevent Acute Renal Failure

Phase 3

• Conditions: Cardiovascular Disease; Acute Renal Failure; Death

• Registration Number: NCT00110201
• Lead Sponsor: Ejaz, Abulate A, MD

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2005-03
• Status Verified: 2005-05
• Study First Submitted: 2005-05-04
• Study First Submitted QC: 2005-05-04
• Study First Posted: 2005-05-05
• Last Update Submitted: 2005-06-23
• Last Update Posted: 2005-06-24
• Study Completion: 2007-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 124

Inclusion Criteria

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

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Need for dialysis and/or mortality

Secondary Outcome Measures

Name	Time	Method
Rise in serum creatinine
blood urea nitrogen

Trial Locations

Locations (1)

Shands Hospital at the University of Florida; 🇺🇸 Gainesville, Florida, United States