Cardiovascular Disease Clinical Trial
Official title:
Prophylactic Use of Nesiritide (Brain Natriuretic Peptide, BNP) for the Prevention of Acute Renal Failure in Thoracic Aortic Aneurysm Surgery Patients
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.
Status | Recruiting |
Enrollment | 124 |
Est. completion date | December 2007 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
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) |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
United States | Shands Hospital at the University of Florida | Gainesville | Florida |
Lead Sponsor | Collaborator |
---|---|
Ejaz, Abulate A, MD |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Need for dialysis and/or mortality | |||
Secondary | Rise in serum creatinine | |||
Secondary | blood urea nitrogen |
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