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Clinical Trial: The Use of Nesiritide in Thoracic Aneurysm Repair to Prevent Acute Renal Failure
This study is currently recruiting patients.
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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 | Treatment or Intervention | Phase |
|---|---|---|
| Cardiovascular Disease Acute Renal Failure Death | Drug: Nesiritide | Phase III |
MedlinePlus related topics: End of Life Issues; Heart Diseases; Kidney Failure; Vascular Diseases
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
Secondary Outcomes: Rise in serum creatinine; blood urea nitrogen
Expected Total Enrollment: 124
Study start: March 2005; Expected completion: December 2007
Last follow-up: December 2007; Data entry closure: 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 above, Genders Eligible for Study: Both
Criteria
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)
Location and Contact Information
Florida
Shands Hospital at the University of Florida, Gainesville, Florida, 32610, United States; Recruiting
More Information
Record last reviewed: May 2005
Last Updated: May 4, 2005
Record first received: May 4, 2005
ClinicalTrials.gov Identifier: NCT00110201
Health Authority: United States: Food and Drug Administration
ClinicalTrials.gov processed this record on 2005-05-17
Source: ClinicalTrials.gov
Cache Date: May 18, 2005
Resources
- Crib death (MayoClinic)

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