The Use of Nesiritide in Thoracic Aneurysm Repair to Prevent Acute Renal Failure
Primary Purpose
Cardiovascular Disease, Acute Renal Failure, Death
Status
Unknown status
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Nesiritide
Sponsored by
About this trial
This is an interventional prevention trial for Cardiovascular Disease focused on measuring Acute renal failure, Nesiritide, Cardiovascular surgery
Eligibility 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)
Sites / Locations
- Shands Hospital at the University of FloridaRecruiting
Outcomes
Primary Outcome Measures
Need for dialysis and/or mortality
Secondary Outcome Measures
Rise in serum creatinine
blood urea nitrogen
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00110201
Brief Title
The Use of Nesiritide in Thoracic Aneurysm Repair to Prevent Acute Renal Failure
Official Title
Prophylactic Use of Nesiritide (Brain Natriuretic Peptide, BNP) for the Prevention of Acute Renal Failure in Thoracic Aortic Aneurysm Surgery Patients
Study Type
Interventional
2. Study Status
Record Verification Date
May 2005
Overall Recruitment Status
Unknown status
Study Start Date
March 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
December 2007 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Ejaz, Abulate A, MD
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cardiovascular Disease, Acute Renal Failure, Death
Keywords
Acute renal failure, Nesiritide, Cardiovascular surgery
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
124 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Nesiritide
Primary Outcome Measure Information:
Title
Need for dialysis and/or mortality
Secondary Outcome Measure Information:
Title
Rise in serum creatinine
Title
blood urea nitrogen
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
R Allan Finlay, RN
Phone
352-273-5356
Email
finlara@medicine.ufle.edu
Facility Information:
Facility Name
Shands Hospital at the University of Florida
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32610
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Richard A Finlay, RN
Phone
352-273-5356
Email
finlara@medicine.ufl.edu
12. IPD Sharing Statement
Citations:
PubMed Identifier
22595385
Citation
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.
Results Reference
derived
PubMed Identifier
19752530
Citation
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.
Results Reference
derived
PubMed Identifier
19660420
Citation
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.
Results Reference
derived
Learn more about this trial
The Use of Nesiritide in Thoracic Aneurysm Repair to Prevent Acute Renal Failure
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