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The Use of Nesiritide in Thoracic Aneurysm Repair to Prevent Acute Renal Failure - Article


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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.

Sponsored by: Ejaz, Abulate A, MD
Information provided by: Ejaz, Abulate A, MD

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

Further Study Details: 
Primary Outcomes: Need for dialysis and/or mortality
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

Please refer to this study by ClinicalTrials.gov identifier  NCT00110201

R Allan Finlay, RN      352-273-5356    finlara@medicine.ufle.edu

Florida
      Shands Hospital at the University of Florida, Gainesville,  Florida,  32610,  United States; Recruiting
Richard A Finlay, RN  352-273-5356    finlara@medicine.ufl.edu 

More Information

Study ID Numbers:  bnpufl2005; 20050059
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

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Page Updated: October 1, 2005
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