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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Cardiovascular Disease, Acute Renal Failure, Death

Intervention / Treatment
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* Drug: Nesiritide


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Nesiritide|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Need for dialysis and/or mortality |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rise in serum creatinine |  |  | 
| blood urea nitrogen |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acute renal failure, Nesiritide, Cardiovascular surgery