A Randomized Controlled Study Investigating Standard Dose Continuous Renal Replacement Therapy (CRRT) Versus Low-Dose CRRT - The "Ketzerei" Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 165
- 试验地点
- 4
- 主要终点
- Number of days alive and free from CRRT
研究概览
简要总结
Acute kidney injury (AKI) is a well-recognized complication in critically ill patients, which often leads to the necessity of mechanical kidney support (CRRT).
In current therapeutic regimes, CRRT is used to strictly prevent azotaemia. Thus recent clinical observations, as well as data from animal testing suggest a link between controlled azotaemia and faster renal recovery in AKI patients.
The aim of the study is to improve renal recovery.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
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
- •Adult patients (age ≥18 years)
- •Critically ill patients with AKI + in need of CRRT
- •Written informed consent
排除标准
- •Chronic dialysis dependency
- •Chronic kidney disease with estimated glomerular filtration rate (eGFR) <30 ml/min/1.73m²
- •severe liver cirrhosis (Child-pugh C)
- •severe acidosis (pH < 7,20 at study enrolment)
- •severe hyperkalaemia (> 6mmol/l)
- •Pregnancy or breastfeeding
- •persons held in an institution by legal or official order
- •Dependency on the investigator or center
研究组 & 干预措施
Intervention Group
CRRT will be established with a draining dose (effluent dose) of 10-15ml/kg/h in pursuit of establishing a controlled azotaemia.
干预措施: Effluent dose of CRRT (Other)
Control Group
Standard of Care:
CRRT will be established with a draining dose (effluent dose) of 25-30ml/kg/h
干预措施: Effluent dose of CRRT (Other)
结局指标
主要结局
Number of days alive and free from CRRT
时间窗: Between Randomization and day 28
次要结局
- Number of Adverse Events (rooted in uraemia, i.e. throwing up, seizures, uremic coma etc.)(Between randomization and day 28)
- Mortality(Day 30 after randomization)
- Number of patients alive and dialysis-free at day 30(Day 30 after randomization)
- Number of days with renal replacement therapy(Between randomization and day 28)
- Length of Intensive Care Unit (ICU) stay(Between randomization and day 28)
- Length of Hospital stay(Between randomization and day 28)
- Expense of treatment (including hospital stay/all measures taken)(From randomization until day 30 after randomization)
- Total amount of dialysis fluid utilized adjusted for weight(From randomization until day 30)
- Presence of Major adverse kidney events (MAKE)(Day 30 after randomization)
- Number of new infections since randomization(From randomization until day 30)