NCT02961478已完成3 期
Measurement of Iohexol Plasma Clearance in Patients Leaving ICU After Acute Renal Failure
University Hospital, Angers12 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2017年2月10日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 150
- 试验地点
- 12
- 主要终点
- Frequency of patients with a clearance of iohexol < 60 ml/min/1m273 at the end of ICU hospitalisation.
研究概览
简要总结
IOXSOR study's purpose to determine the frequency of non resolutive renal failure (estimated by the clearance of iohexol) at end of stay in ICU patients who have had acute renal failure episode.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
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
- •ICU stay > 7 days
- •Having presented during the stay renal failure stage 2 or 3 Kidney Disease Improving Global Outcomes (KDIGO)
- •Steady improvement of renal function before the ICU discharge :
- •Creatinine before ICU discharge <110 µmol / L for women, <130 µmol / L for men
- •No recourse to extra renal purification
- •Change in creatinine levels (ΔCréatinine) less than 20% over two measures spaced 24 hours within 48 hours preceding the discharge
- •Expected discharge ICU within 48 hours :
- •Glasgow score > 13
- •Lack of mechanical ventilation except home Noninvasive Mechanical Ventilation (NiMV)
- •Lack of use of catecholamine
- •No contra-indication for discharge according to physician in charge of the patient
- •Informed consent signed by the patient, where not possible by the person of trust or the family if present. Written consent by the patient will be obtained as soon as deemed possible.
排除标准
- •Iohexol administration within 48 hours preceding the potential inclusion (imaging examination with X-ray contrast medium injection)
- •Iohexol administration planned within 24 hours after potential inclusion in the study
- •Known medical history of immediate allergic or delayed skin allergic reaction to injection of iodinated contrast material or any serious doubt on this medical history
- •Patient receiving from extra renal purification during ICU discharge
- •Chronic renal disease known (creatinine> 110 µmol / L for women,> 130 µmol / L for men) or creatinine clearance estimated less than 60 mL / min
- •Pregnancy or breastfeeding women
- •Patient under guardianship or safeguard justice known at the time of inclusion
- •Patient limitation care
- •Person not affiliated or not the beneficiary of a social security scheme
研究组 & 干预措施
Iohexol plasmatic clearance
Experimental
干预措施: IOHEXOL (Drug)
结局指标
主要结局
Frequency of patients with a clearance of iohexol < 60 ml/min/1m273 at the end of ICU hospitalisation.
时间窗: 24 hours
Iohexol clearance pharmacokinetics
次要结局
- Correlation between non resolutive renal at the end of ICU (iohexol clearance < 60 ml/min/1m273) and creatinine clearance < 60 ml/min/1m273 at 6 month after ICU. discharge(Six month after ICU discharge)
- Number of risk factors associated with non resolutive among : Age Previous renal function Comorbidities Severity parameters of renal aggression Acute severity of parameters during the ICU hospitalisation(24 hours)
- Correlation between serum creatinine derived measurements of Glomerular Filtratio Rate and iohexol clearance.(24 hours)
研究者
研究点 (12)
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