Evaluation of the Impact of Online Hemodiafiltration vs Conventional Hemodialysis in Acute Kidney Injury on Inflammatory and Clinical Outcomes
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 45
- 试验地点
- 3
- 主要终点
- Participant accrual (feasibility)
研究概览
简要总结
Only limited data exist on the benefit of online hemodiafiltration in patient with Acute kidney injury. The objective of this pilot RCT is to assess the feasibility of a large multicentre RCT to determine whether, in patients with AKI requiring acute renal replacement therapy, does exposure to Online Hemodiafiltration reduce the inflammatory status and improve renal recovery compared to conventional intermittent hemodialysis at the ICU.
详细描述
Despite sparse data on the advantages of hemodiafiltration over conventional hemodialysis for intermittent dialysis, there is limited data comparing these modalities in AKI from various aetiologies in critically ill patients. As RCTs involving renal replacement therapy at the ICU are exceptionally challenging to complete, thus a rigorous RCT based on appropriate sample size and relevant clinical outcomes is crucial. The objective of this pilot RCT is to assess the feasibility of a larger multicentre RCT to determine whether, in patients with AKI requiring acute renal replacement therapy, does exposure to Post-dilution Hemodiafiltration or Pre-dilution Hemodiafiltration reduce the inflammatory status and improve renal recovery compared to conventional intermittent hemodialysis at the ICU. As post-dilution HDF has never been adequately evaluated in an ICU context, comparison between pre-dilution and post-dilution HDF is also required to confirm feasibility.
This proof-of-concept pilot trial will focus on three feasibility endpoints. It will be considered successful if the following criteria are achieved :
- Protocol adherence: If ≥85% of overall dialysis sessions are administered per-protocol according to the allocated modality
- Adherence to follow-up: If it was possible to obtain end-of-study outcomes in ≥90% of participants, and
- Participant accrual: If the average monthly enrolment is 4 or more participants per months.
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
- •Hospitalised in the ICU
- •Acute kidney injury stage 3 (KDIGO-AKI Criteria)
- •Requiring RRT for AKI, as judged by the attending clinician (initiation) or conversion from CRRT to intermittent dialysis
- •Adult of 18 years or more
排除标准
- •Female subjects who are pregnant or breast-feeding or considering becoming pregnant during the study.
- •Subjects who are participating in another study involving dialysis interventions
- •Subjects or relatives/next-of-kin unable to provide written informed consent
- •Creatinine clearance (CrCl) < 30 mL/min measured by 24-hour urine collection or eGFR or on chronic dialysis at baseline
- •Subjects on active immunosuppressive therapy (>10mg of prednisone, biologic therapies, calcineurin inhibitors, mTOR inhibitors or antimetabolites)
- •Subjects with active contraindication to anticoagulation during dialysis session
- •Subjects whose RRT is not part of their life goal
结局指标
主要结局
Participant accrual (feasibility)
时间窗: 90 days
If the average monthly enrolment is 4 or more participants per months
Protocol adherence (feasibility)
时间窗: 90 days
If ≥85% of overall dialysis sessions are administered per-protocol according to the allocated modality
Adherence to follow-up (feasibility)
时间窗: 90 days
If it was possible to obtain end-of-study outcomes in ≥90% of participants
次要结局
- Mortality(90 days)
- Number of dialysis session complicated by Circuit/filter clotting(90 days)
- Dialysis dependence(90 days)
- Total number of days on dialysis(90 days)
- End-of-study eGFR(90 days)
- Length of hospitalisation stay(90 days)
- Number of patients with hemodynamic instability during dialysis treatment (first week)(7 days)