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
研究概览
地位
条件
详细说明
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.
研究类型
注册 (实际的)
联系人和位置
学习地点
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British Columbia
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Vancouver、British Columbia、加拿大
- University of British Columbia
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-
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Colorado
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Denver、Colorado、美国
- St. Anthony's Central Hospital
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District of Columbia
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Washington、District of Columbia、美国
- George Washington University
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Maine
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Portland、Maine、美国
- Maine Medical Center
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Massachusetts
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Boston、Massachusetts、美国
- Beth Israel Deaconess Medical Center
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Boston、Massachusetts、美国
- Massachusetts General Hospital
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New York
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Albany、New York、美国
- St. Peters Healthcare
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Brooklyn、New York、美国
- New York Methodist
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Ohio
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Cleveland、Ohio、美国
- Cleveland Clinic Foundation
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Pennsylvania
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Pittsburgh、Pennsylvania、美国
- University of Pittsburgh
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Texas
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Houston、Texas、美国
- University of Texas, Houston
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-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
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
学习计划
研究是如何设计的?
设计细节
- 观测模型:队列
- 时间观点:预期
队列和干预
团体/队列 |
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1
High Risk population for developing AKI during/after CABG surgery.
|
2
Medium Risk population for developing AKI during/after CABG surgery.
|
合作者和调查者
赞助
调查人员
- 首席研究员:Emil Paganini, MD、The Cleveland Clinic
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
其他研究编号
- BSTE-0401
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