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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2005 by Ejaz, Abulate A, MD.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Ejaz, Abulate A, MD
ClinicalTrials.gov Identifier:
NCT00110201
First received: May 4, 2005
Last updated: June 23, 2005
Last verified: May 2005
  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

Resource links provided by NLM:


Further study details as provided by Ejaz, Abulate A, MD:

Primary Outcome Measures:
  • Need for dialysis and/or mortality

Secondary Outcome Measures:
  • Rise in serum creatinine
  • blood urea nitrogen

Estimated Enrollment: 124
Study Start Date: March 2005
Estimated Study Completion Date: December 2007
Detailed Description:

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
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)
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00110201

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

Locations
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   
Sponsors and Collaborators
Ejaz, Abulate A, MD
  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:
Cardiovascular Diseases
Renal Insufficiency
Acute Kidney Injury
Kidney Diseases
Urologic Diseases
Natriuretic Peptide, Brain
Natriuretic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 16, 2014