- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00110201
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
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.
Study Overview
Status
Conditions
Intervention / Treatment
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
Enrollment
Phase
- Phase 3
Contacts and Locations
Study Locations
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Florida
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Gainesville, Florida, United States, 32610
- Recruiting
- Shands Hospital at the University of Florida
-
Contact:
- Richard A Finlay, RN
- Phone Number: 352-273-5356
- Email: finlara@medicine.ufl.edu
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Need for dialysis and/or mortality
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Secondary Outcome Measures
Outcome Measure |
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Rise in serum creatinine
|
blood urea nitrogen
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Dass B, Shimada M, Kambhampati G, Ejaz NI, Arif AA, Ejaz AA. Fluid balance as an early indicator of acute kidney injury in CV surgery. Clin Nephrol. 2012 Jun;77(6):438-44. doi: 10.5414/cn107278.
- Ejaz AA, Beaver TM, Shimada M, Sood P, Lingegowda V, Schold JD, Kim T, Johnson RJ. Uric acid: a novel risk factor for acute kidney injury in high-risk cardiac surgery patients? Am J Nephrol. 2009;30(5):425-9. doi: 10.1159/000238824. Epub 2009 Sep 11.
- Ejaz AA, Martin TD, Johnson RJ, Winterstein AG, Klodell CT, Hess PJ Jr, Ali AK, Whidden EM, Staples NL, Alexander JA, House-Fancher MA, Beaver TM. Prophylactic nesiritide does not prevent dialysis or all-cause mortality in patients undergoing high-risk cardiac surgery. J Thorac Cardiovasc Surg. 2009 Oct;138(4):959-64. doi: 10.1016/j.jtcvs.2009.05.014. Epub 2009 Jul 3.
Study record dates
Study Major Dates
Study Start
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- bnpufl2005
- 20050059
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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