Recruiting
Phase 3

Nesiritide

Sponsor:

Ejaz, Abulate A, MD

Code:

NCT00110201

Conditions

Cardiovascular Disease

Acute Renal Failure

Death

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Nesiritide

Study Details

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.

Conditions

Cardiovascular Disease

Acute Renal Failure

Death

Study ID

NCT00110201

Start date

Mar, 2005

Status verified date

May, 2005

Completion date

Dec, 2007

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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)

Study Design

Enrollment

124 participants

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Interventions

Nesiritide

Primary outcome measure

  • Need for dialysis and/or mortality [ Time Frame: undefined ]

Central Contacts and Locations

Central contacts

R Allan Finlay, RN

352-273-5356finlara@medicine.ufle.edu

Locations

Shands Hospital at the University of Florida

Recruiting

Gainesville, Florida, United States, 32610

Contacts

Richard A Finlay, RN

352-273-5356finlara@medicine.ufl.edu

More Information

Sponsor

Ejaz, Abulate A, MD

Last update posted

Jun 24, 2005

Last verified

May, 2005

Keywords

  • Acute renal failure
  • Nesiritide
  • Cardiovascular surgery

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Ejaz, Abulate A, MD on 2005-06-24.