The Use of Nesiritide in Thoracic Aneurysm Repair to Prevent Acute Renal Failure
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Purpose
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 |
|---|---|---|
|
Cardiovascular Disease Acute Renal Failure Death |
Drug: Nesiritide |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind 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
| 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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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)
Contacts and Locations| 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 | |
More Information
No publications provided by Ejaz, Abulate A, MD
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| ClinicalTrials.gov Identifier: | NCT00110201 History of Changes |
| Other Study ID Numbers: | bnpufl2005, 20050059 |
| Study First Received: | May 4, 2005 |
| Last Updated: | June 23, 2005 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Ejaz, Abulate A, MD:
|
Acute renal failure Nesiritide Cardiovascular surgery |
Additional relevant MeSH terms:
|
Aneurysm Cardiovascular Diseases Acute Kidney Injury Renal Insufficiency Aortic Aneurysm, Thoracic Vascular Diseases Kidney Diseases Urologic Diseases |
Aortic Aneurysm Aortic Diseases Natriuretic Peptide, Brain Natriuretic Agents Physiological Effects of Drugs Pharmacologic Actions Cardiovascular Agents Therapeutic Uses |
ClinicalTrials.gov processed this record on May 16, 2013