- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 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.
연구 개요
상세 설명
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.
연구 유형
등록
단계
- 3단계
연락처 및 위치
연구 장소
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Florida
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Gainesville, Florida, 미국, 32610
- 모병
- Shands Hospital at the University of Florida
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연락하다:
- Richard A Finlay, RN
- 전화번호: 352-273-5356
- 이메일: finlara@medicine.ufl.edu
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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)
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
|---|
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Need for dialysis and/or mortality
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2차 결과 측정
결과 측정 |
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Rise in serum creatinine
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blood urea nitrogen
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공동 작업자 및 조사자
간행물 및 유용한 링크
일반 간행물
- 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.
연구 기록 날짜
연구 주요 날짜
연구 시작
연구 완료
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
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