Recombinant Human Erythropoietin Use in ICU Patients: Does it Prevent Acute Renal Failure?
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- mean change (%) from baseline in urinary NGAL concentration at 96 hr after rhu EPO injection
研究概览
简要总结
Pilot study aiming to assess the effect of two doses of rhu EPO on urine NGAL concentration and on serum cystatin C and creatinine levels in critically ill patients at risk of ARF.
详细描述
Research plan Open-label randomized trial Twelve months duration trial Setting: Medical and Surgical Intensive Care Unit of the University Hospitals of Geneva Start of trial: Mid-May 2008
Patients randomly allocated to 2 treatment groups (20 patients per group), or a control group (40 patients):
- Group 1: control group (40 patients)
- Group 2 : 20000 IU rhu Epo (20 patients) administered by the i.v. route
- Group 3 : 40000 IU rhu Epo (20 patients) administered by the i.v. route
3.2. Trial design Day 0 Consent form signed Patients randomly allocated to control or treatment groups (20000 and 40000 IU) Serum Cystatin C determination Serum Creatinine determination Urinary NGAL determination Administration of intravenous rhu Epo on Day 0 or no Epo (control group) Day 2 At 48 hr after rhu EPO injection, samples will be taken for
- Serum Cystatin C determination
- Serum Creatinine determination
- Urinary NGAL determination Day 4 At 96 hr after rhu EPO injection, samples will be taken for
- Serum Cystatin C determination
- Serum Creatinine determination
- Urinary NGAL determination
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- •Patients at risks for acute tubular necrosis (patients with mechanical ventilation, patients with sepsis, in the post-operative state, with hemodynamic impairment or with previous chronic renal failure.
- •Consent form signed
排除标准
- •Patients with malignant hypertension
- •Patients with systolic BP > 150 mmHg at enrollment
- •Patients with Hb level > 120g/L
- •Patients with acute coronaropathy
- •Pregnancy
- •Patients with urine output < 600 ml/12 h
研究组 & 干预措施
2
Administration of intravenous rhu Epo on Day 0
干预措施: epoetinum (Drug)
结局指标
主要结局
mean change (%) from baseline in urinary NGAL concentration at 96 hr after rhu EPO injection
时间窗: 4 days
次要结局
- mean change (%) from baseline in serum Cystatin C concentration at 96 hr after rhu EPO injection(4 days)