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

Prophylactic Use of Nesiritide (Brain Natriuretic Peptide, BNP) for the Prevention of Acute Renal Failure in Thoracic Aortic Aneurysm Surgery Patients

Status
UNKNOWN
Phases
Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00110201
Enrollment
124
Registered
2005-05-05
Start date
2005-03-31
Completion date
2007-12-31
Last updated
2005-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Renal Failure, Cardiovascular Disease, Death

Keywords

Acute renal failure, Nesiritide, Cardiovascular surgery

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.

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.

Interventions

DRUGNesiritide

Sponsors

Ejaz, Abulate A, MD
Lead SponsorINDIV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frame
Need for dialysis and/or mortality

Secondary

MeasureTime frame
Rise in serum creatinine
blood urea nitrogen

Countries

United States

Contacts

Primary ContactR Allan Finlay, RN
finlara@medicine.ufle.edu352-273-5356

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026