The Use of Nesiritide in Thoracic Aneurysm Repair to Prevent Acute Renal Failure
Recruitment status was: Recruiting
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.
|Cardiovascular Disease Acute Renal Failure Death||Drug: Nesiritide||Phase 3|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Prevention
|Official Title:||Prophylactic Use of Nesiritide (Brain Natriuretic Peptide, BNP) for the Prevention of Acute Renal Failure in Thoracic Aortic Aneurysm Surgery Patients|
- Need for dialysis and/or mortality
- Rise in serum creatinine
- blood urea nitrogen
|Study Start Date:||March 2005|
|Estimated Study Completion Date:||December 2007|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00110201
|Contact: R Allan Finlay, RNfirstname.lastname@example.org|
|United States, Florida|
|Shands Hospital at the University of Florida||Recruiting|
|Gainesville, Florida, United States, 32610|
|Contact: Richard A Finlay, RN 352-273-5356 email@example.com|