- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT00445809
Evaluation of Neutrophil Gelatinase-associated Lipocalin (NGAL) in Early and Evolving Acute Kidney Injury (EVOLVE)
EValuation Of NGAL in Early and eVolving Acute kidnEy Injury
연구 개요
상태
정황
상세 설명
Approximately 350 adults scheduled to undergo cardiac surgery involving the use of cardiopulmonary bypass will be enrolled. Blood samples will be obtained from all patients in the study for future measurement of both plasma NGAL and plasma creatinine levels in the same sample at each of nine time points.
Blood samples for later assessment using the Triage NGAL Test will be processed to plasma at the clinical site, frozen and shipped to Biosite for storage. Testing with the Triage NGAL Test will be conducted at Biosite by trained laboratory personnel. The results of these assessments will be blinded to the medical team during the study and will not impact the medical management of the patient.
The medical team caring for each study patient should obtain clinical laboratory tests per their usual post-operative routine and manage the patient accordingly. Any serum creatinine measurements obtained by the site as part of this routine care both pre-operatively and through Day 10 post-operatively will be recorded as well as any additional post-operative renal insults, the development of oliguria, the need for a nephrology consultation, initiation of dialysis and mortality will also be recorded through Day 10.
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
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Colorado
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Denver, Colorado, 미국
- St. Anthony's Central Hospital
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District of Columbia
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Washington, District of Columbia, 미국
- George Washington University
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Maine
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Portland, Maine, 미국
- Maine Medical Center
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Massachusetts
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Boston, Massachusetts, 미국
- Beth Israel Deaconess Medical Center
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Boston, Massachusetts, 미국
- Massachusetts General Hospital
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New York
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Albany, New York, 미국
- St. Peters Healthcare
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Brooklyn, New York, 미국
- New York Methodist
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Ohio
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Cleveland, Ohio, 미국
- Cleveland Clinic Foundation
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Pennsylvania
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Pittsburgh, Pennsylvania, 미국
- University of Pittsburgh
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Texas
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Houston, Texas, 미국
- University of Texas, Houston
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British Columbia
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Vancouver, British Columbia, 캐나다
- University of British Columbia
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
4.2.1 Inclusion Criteria
- Male or female scheduled for cardiovascular surgery (other than cardiac transplant) requiring cardiopulmonary bypass
- 18 years of age or older
i. The first approximately 150 to200 patients enrolled must have:
• A Prediction of Acute Renal Failure Score ≥ 5 (see Reference 18 and Appendix B)
ii. The subsequent patients enrolled must have one or more of the following risk factors for post-bypass renal injury:
- Age > 70;
- Pre-operative creatinine > 1.4 mg/dL;
- NYHA Class 3 or 4 heart failure or left ventricular ejection fraction < 35%;
- Insulin-dependent diabetes mellitus;
- Undergoing cardiac valve surgery;
- History of previous cardiac surgery.
Exclusion Criteria:
- Age < 18 years
- Inability to obtain Informed Consent from patient or representative
- Prisoners or other institutionalized or vulnerable individuals
- Participation in an interventional clinical study within the previous 30 days
- History of previous renal transplantation
- Stage 5 chronic kidney disease (estimated GRF<15 mL/min/1.73m2) (See Appendix C)
- Known or suspected ongoing pre-operative acute renal failure due to any cause, including pre-renal, intrinsic renal or post-renal (obstructive) etiologies (as evidenced by increasing serum creatinines or oliguria pre-operatively)
- Already receiving dialysis, in imminent need of dialysis or considered highly likely to need dialysis in the immediate post-operative period for fluid management
- Any known or suspected renal ischemic insult(such as cardiac arrest)or nephrotoxic insult(other than intravascular contrast procedure) during the 48 hours prior to surgery
- Known or suspected infection with human immunodeficiency virus (HIV), hepatitis C virus (HCV)infection, hepatitis B virus (HBV) infection or other infectious hepatitis
- Pre-operative hematocrit <25%, recent blood transfusions have been administered to maintain hematocrit >25% or any other contraindication to obtaining the study-specified blood samples
- Undergoing cardiac transplantation
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 관찰 모델: 보병대
- 시간 관점: 유망한
코호트 및 개입
그룹/코호트 |
---|
1
High Risk population for developing AKI during/after CABG surgery.
|
2
Medium Risk population for developing AKI during/after CABG surgery.
|
공동 작업자 및 조사자
스폰서
수사관
- 수석 연구원: Emil Paganini, MD, The Cleveland Clinic
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
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
이 연구와 관련된 용어
기타 연구 ID 번호
- BSTE-0401
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