The Study of Safety, Feasibility and Efficacy of Automated Peritoneal Dialysis in Acute Kidney Injury as Compared With Intermittent Hemodialysis, a Multi-center Non-blind Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 100
- 试验地点
- 5
- 主要终点
- The rate of renal function recovery (independence of dialysis)
研究概览
简要总结
This is a multi-center randomized clinical trial study. The purpose of this study is to examine safety, feasibility and efficacy of automated peritoneal dialysis as compared with intermittent hemodialysis for AKI patients with indications for dialysis.
详细描述
The incidence of acute kidney injury (AKI) is rapidly increasing worldwide. This is a common and devastating disorder, especially in critical illnesses, affecting 5-8% of all hospitalized patients and up to 30% of those in intensive care units, with high mortality. About 50-80% critical patients with AKI needed dialysis treatment. Intermittent hemodialysis (IHD) might be the most-commonly modalities applied in AKI patients requiring dialysis. However, no data of randomized study concerning renal recovery and treatment efficiency of AKI patients treated with APD is available in Chinese adult patients. This study is a 2-armed randomized controlled non-blind non-inferior trial to explore the feasibility, efficacy, and safety of APD in AKI patients as compared with intermittent hemodialysis. Base on the sample size estimation, 100 subjects (n=50 in each arm) should be enrolled in this study. The primary outcome is the rate of renal recovery (independence of dialysis) in the first 21days after initiation of renal replacement.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •AKI patients according to Acute Kidney Injury Network criteria
- •Rapidly rising serum creatinine level (a sudden increase of at least 30%)
- •Meeting the indications for dialysis
- •Uremia or azotemia (BUN>80 mg/dl)
- •Fluid overload (after diuretics use)
- •Electrolyte imbalance (K>5.5 mEq/L after clinical treatment)
- •Acid-base disturbance (pH<7.2 and bicarbonate<10mEq/L after clinical treatment)
排除标准
- •Age under 18 years, or older than 80 years
- •Urinary tract obstruction; acute interstitial nephritis or rapidly progressive glomerulonephritis needed immunoinhibitory therapy
- •Previously received renal replacement therapy(RRT) of any type/presence of dialysis access during the current illness.
- •Pre-existing severe chronic kidney disease (baseline serum creatinine>4mg/dl) more than 10 days prior to initiation of first RRT.
- •Absolute contraindication of peritoneal dialysis such as recent abdominal surgery (<1month), multiple abdominal surgeries.
- •Absolute contraindication for hemodialysis such as hemodynamic instability (systolic blood pressure <80mmHg).
- •Pregnant.
结局指标
主要结局
The rate of renal function recovery (independence of dialysis)
时间窗: At 21 days after the initiation of dialysis
Patients do not require dialysis, urine output\>1000ml/d and progressive drop in serum creatinine(\<4mg/dl) and BUN(\<50mg/dl).
次要结局
- Access related complications within 21 days(At 21 days after the initiation of dialysis)
- Access related complications within 90 days(At 90 days after the initiation of dialysis)
- Mini-Mental State Examination (MMSE) score within 21 days(At 21 days after the initiation of dialysis)
- All-cause mortality within 21 days(At 21 days after the initiation of dialysis)
- Length of stay in hospital(From the time of admission to the time of discharge, up to 90 days)
- Herth Hope Index within 21 days(At 21 days after the initiation of dialysis)
- Simplified Nutritional Appetite Questionnaire (SNAQ) score within 21 days(At 21 days after the initiation of dialysis)
- All-cause mortality within 90 days(At 90 days after the initiation of dialysis)
- Dialysis related complications within 21 days(At 21 days after the initiation of dialysis)
- The percentage of participants requiring termination of primary dialysis modality(At 90 days after the initiation of dialysis)
- Health Status Questionnaire (Short Form-36) score within 21 days(At 21 days after the initiation of dialysis)
研究者
Limeng Chen
Professor of Medicine, Associate Chief of Nephrology Division
Peking Union Medical College Hospital