NCT01544231已完成不适用
Plasma Neutrophil Gelatinase Associated Lipocalin (NGAL) Levels During Emergency Management of Rhabdomyolysis: Predicting Renal Failure
Centre Hospitalier Universitaire de Nīmes5 个研究点 分布在 1 个国家目标入组 197 人开始时间: 2013年8月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 197
- 试验地点
- 5
- 主要终点
- Plasma NGAL level
研究概览
简要总结
This research project consists of a prospective diagnostic study conducted on patients with clinical suspicion of rhabdomyolysis admitted to the emergency rooms of the University Hospitals of Nimes, Montpellier, Paris, Nice and Toulon Inter Army Hospital. The main objective of this study is to determine whether the plasma level of Neutrophil Gelatinase Associated Lipocalin (NGAL) may be retained as a predictor of acute renal failure (ARF) occurring within 48 hours after admission for rhabdomyolysis.
详细描述
The secondary objectives of this are:
- to study plasma NGAL levels on admission to the emergency ward as a marker of morbidity and mortality by considering the following factors: duration of hospitalization, need for extracorporeal blood purification, ICU admission, death.
- to study the delay between the onset of the proposed cause of rhabdomyolysis and treatment initiation
- to study the delay between treatment initiation and the occurrence of ARF.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patient must have given his/her informed and signed consent
- •The patient must be insured or beneficiary of a health insurance plan
- •Patient hospitalized with Creatine Phospho-Kinase > 1000 UI/l
排除标准
- •The patient is participating in another study
- •The patient is in an exclusion period determined by a previous study
- •The patient is under judicial protection, under tutorship or curatorship
- •The patient refuses to sign the consent
- •It is impossible to correctly inform the patient
- •The patient is pregnant, parturient, or breastfeeding
- •Chronic renal insufficiency with dialysis
- •The patient has an acute coronary syndrome
- •Nephrotoxic medications within 72 hours prior to admission
- •Need for a procedure involving the injection of iodine
- •Patient in shock
- •Occurrence of acute renal failure can be explained by a cause other than rhabdomyolysis.
研究组 & 干预措施
Patients
Adult patients with suspected rhabdomyolysis admitted to the participating University Hospital emergency rooms (see inclusion/exclusion criteria).
干预措施: Plasma NGAL level (Biological)
结局指标
主要结局
Plasma NGAL level
时间窗: Admittance to the ermergency room (ie at baseline)
ng/ml
次要结局
- Need for extracorporeal blood purification(Hospital discharge (expected average of 2-3 days))
- Delay between cause and treatment(Day 2)
- Patient deceased during hospitalization(Hospital discharge (expected average of 2-3 days))
- Patient admitted to ICU?(Hospital discharge (expected average of 2-3 days))
- Delay between initiation of treatment and beginning of acute renal failure(Day 2)
- Length of hospitalization(Hospital discharge (expected average of 2-3 days))
研究者
研究点 (5)
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