Intensive Versus Regular Dosage For Peritoneal Dialysis In Non-Hypercatabolic Acute Kidney Injury, A Multicenter Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 6
- 试验地点
- 7
- 主要终点
- Recruitment rate of the trial
研究概览
简要总结
This is a multicenter, pilot RCT study, aiming to compare intensive dosage and regular dosage of PD for AKI patients with indications for dialysis.
Aims of the study are to:
Examine the feasibility of the study, which aims to determine the efficacy and safety of intensive PD dose for AKI patients as compared to regular PD dose.
Establish the appropriate workflow for PD treatment for AKI patients.
详细描述
The incidence of acute kidney injury (AKI) is rapidly increasing worldwide, which partly due to greater recognition of AKI, more exposure to various nephrotoxins and an ageing population with increased burden of non-infectious chronic disease. Intermittent hemodialysis (IHD) or continuous renal replacement therapy (CRRT) (i.e. venous-venous HD or hemofiltration) are the most-commonly modalities applied for acute kidney injury (AKI) patients in both developed and developing countries. By contrast, the use of peritoneal dialysis (PD) has been rare. There are no consensus on the ideal dosage and target of adequacy for PD in AKI. Therefore, we are to perform a multicenter, pilot RCT study, aiming to compare intensive dosage and regular dosage of PD for AKI patients with indications for dialysis. If successful, this strategy is expected to enhance the remedy rate of AKF patients, especially in developing regions/countries.
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
- 14 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age older than 14 years;
- •Be diagnosed as AKI according to KDIGO recommendation;
- •Having indications for renal replacement therapy.
排除标准
- •Having contraindications to peritoneal dialysis;
- •Functional azotemia;
- •Hypercatabolic status;
- •Previous CKD history (baseline eGFR<60ml/min/1.73m2 or proteinuria);
- •Psychological disorder or communication barrier;
- •Pregnancy;
- •Refusing to receive dialysis therapy.
- •receiving mechanical ventilation.
研究组 & 干预措施
Intervention group
Intervention group is intensive dosage of PD.
干预措施: Intensive dosage of PD (Procedure)
Control group
Control group is regular dosage of PD.
干预措施: Regular dosage of PD (Procedure)
结局指标
主要结局
Recruitment rate of the trial
时间窗: From date of randomization until the randomization of last participant.
Recruitment rate of patients screened for the trial measured by percentage.
Retention rate of the trial
时间窗: From date of randomization until 90 days after the randomization of last participant
Retention rate of included patients in the trial measured by percentage.
Incidence of adverse events
时间窗: From date of randomization until 90 days after the randomization of last participant.
Incidence of adverse events measured by number of events per patient-month
Adherence rate of the trial
时间窗: From date of randomization until 90 days after the randomization of last participant.
Percentage of participants adherent to the dosing regimen of PDDOSE study.
次要结局
- all cause mortality(30-day, 60-day, 90-day after the patient enrolls in the study.)
- length of hospital stay(90 days of the study since the patient enrolls in the study)
- The rate of renal recovery(30-day, 60-day, 90-day after the patient enrolls in the study.)
- Days for dialysis treatment(From date when a patient begins peritoneal dialysis until the date of dialysis withdrawal, assessed up to 90 days.)
- Incidence of dialysis transferring(At 90 days after patient enrolls in the study)
- Incidence of comorbidities(At 90 days after patient enrolls in the study)
- in-hospital cost(At 90 days after patient enrolls in the study)
研究者
Dong Jie
Director of PD center
Peking University First Hospital