Multicentre Randomised Trial of Intermittent Versus Continuous Renal Replacement Therapy for Acute Renal Failure
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 1,628
- 试验地点
- 1
研究概览
简要总结
This multicentre SHARF4 (Stuivenberg Hospital Acute Renal Failure) study aims to investigate outcome in patients with acute renal failure (ARF), stratified according to severity of disease (SHARF score) and randomised to different treatment options.
All adult patients with a serum creatinine >2 mg/dl were included. Patients were stratified according to disease severity and those in need for RRT were randomised to intermittent (IRRT) or continuous renal replacement therapy (CRRT)
详细描述
Subjects. Hospitals qualified for participation if they had at least 600 beds, a centre for the treatment of End Stage Kidney Disease (ESKD) patients, a multipurpose ICU with at least 12 beds, at least 30 patients with ARF treated by RRT during the last year and regular use of both intermittent and continuous techniques. A centre questionnaire was sent to candidate centres in order to check qualifying criteria.
Qualified Belgian ICU units included all adult (age ³ 18 years old) patients with a serum creatinine >2 mg/dl that were consecutively admitted. All patients with known pre-existing chronic renal disease, defined as a serum creatinine above 1.5 mg or with clearly reduced kidney size on ultrasound were excluded.
Severity was defined by calculating the SHARF score in all subjects that fulfilled the inclusion criteria. Patients were stratified in 3 classes (SHARF<30, 30-60, >60). Within each stratum, those in need for renal replacement therapy were randomised to daily IRRT (intermittent haemodialysis during 4-6 hours daily) or CRRT (continuous veno-venous hemofiltration), if none of the predefined contraindications for randomisation were present.
Data collection. The following basic data were collected: demographic (age, sex, weight and height), course of hospitalisation (date of admission to hospital and to ICU, date of discharge from ICU and from hospital or date of death), date of ARF diagnosis, type of ARF (prerenal, renal, postrenal, acute on chronic disease), cause of ARF (acute tubular necrosis, acute glomerulonephritis, acute interstitial nephritis, systemic disease), primary disease type (medical - toxic, medical - other, surgical, obstetric) and serum creatinine at different time points during hospitalisation. Parameters of the SHARF score were collected at the first day that the criteria of ARF were met. For patients referred to the ICU later in the course of their ARF, the day of admission to the ICU was the starting day. Overall severity was evaluated with the APACHE II score at baseline and with the SOFA score at diagnosis of ARF and after 24 and 48 hours.
The following short-term outcome parameters were measured: hospital mortality, length of stay at ICU and hospital and GFR at hospital discharge according to the Cockroft and Gault formula.
研究设计
- 研究类型
- Observational
- 观察模型
- Defined Population
- 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
- •adults (>17 years)
- •having acute renal failure: serum creatinine > 2 mg/dl
- •being in need for chronic renal replacement therapy (the decision to treat conservatively or to start RRT was at the discretion of the attending physician, taking into account the rules of good clinical practice in this field)
排除标准
- •patients with known pre-existing chronic renal disease, defined as a serum creatinine above 1.5 mg/dl or with clearly reduced kidney size on ultrasound were excluded.
