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Sponsored by: |
Ejaz, Abulate A, MD |
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Information provided by: | Ejaz, Abulate A, MD |
ClinicalTrials.gov Identifier: | NCT00110201 |
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.
Condition | Intervention | Phase |
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Cardiovascular Disease Acute Renal Failure Death |
Drug: Nesiritide |
Phase III |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Efficacy Study |
Official Title: | Prophylactic Use of Nesiritide (Brain Natriuretic Peptide, BNP) for the Prevention of Acute Renal Failure in Thoracic Aortic Aneurysm Surgery Patients |
Estimated Enrollment: | 124 |
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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: R Allan Finlay, RN | 352-273-5356 | finlara@medicine.ufle.edu |
United States, Florida | |
Shands Hospital at the University of Florida | Recruiting |
Gainesville, Florida, United States, 32610 | |
Contact: Richard A Finlay, RN 352-273-5356 finlara@medicine.ufl.edu |
Study ID Numbers: | bnpufl2005, 20050059 |
Study First Received: | May 4, 2005 |
Last Updated: | June 23, 2005 |
ClinicalTrials.gov Identifier: | NCT00110201 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Acute renal failure Nesiritide Cardiovascular surgery |
Natriuretic Peptide, Brain Renal Insufficiency Death Urologic Diseases Aortic Aneurysm, Thoracic Aneurysm |
Cardiovascular Agents Renal Insufficiency, Acute Kidney Diseases Kidney Failure, Acute Aortic Aneurysm Kidney Failure |
Natriuretic Peptide, Brain Renal Insufficiency Physiological Effects of Drugs Cardiovascular Agents Pharmacologic Actions Urologic Diseases Natriuretic Agents |
Therapeutic Uses Cardiovascular Diseases Kidney Failure, Acute Kidney Diseases Renal Insufficiency, Acute Kidney Failure |