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

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ClinicalTrials.gov Identifier: NCT00110201
Recruitment Status : Unknown
Verified May 2005 by Ejaz, Abulate A, MD.
Recruitment status was:  Recruiting
First Posted : May 5, 2005
Last Update Posted : June 24, 2005
Sponsor:
Information provided by:
Ejaz, Abulate A, MD

Brief Summary:

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 or disease Intervention/treatment Phase
Cardiovascular Disease Acute Renal Failure Death Drug: Nesiritide Phase 3

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.


Study Type : Interventional  (Clinical Trial)
Enrollment : 124 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
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
Study Start Date : March 2005
Study Completion Date : December 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Aneurysms
Drug Information available for: Nesiritide




Primary Outcome Measures :
  1. Need for dialysis and/or mortality

Secondary Outcome Measures :
  1. Rise in serum creatinine
  2. blood urea nitrogen


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

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
First Posted: May 5, 2005    Key Record Dates
Last Update Posted: June 24, 2005
Last Verified: May 2005

Keywords provided by Ejaz, Abulate A, MD:
Acute renal failure
Nesiritide
Cardiovascular surgery

Additional relevant MeSH terms:
Cardiovascular Diseases
Aneurysm
Renal Insufficiency
Acute Kidney Injury
Vascular Diseases
Kidney Diseases
Urologic Diseases
Natriuretic Peptide, Brain
Natriuretic Agents
Physiological Effects of Drugs