Discontinuation of Continuous Renal Replacement Therapy in Patients with Acute Kidney Injury: a Pilot Quasi-experimental Study (DC-CRRT)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 67
- 试验地点
- 2
- 主要终点
- Successful discontinuation of Continuous Renal Replacement Therapy
研究概览
简要总结
In this study, investigators are going to test whether a standardize approach to discontinuation of Continuous Renal Replacement Therapy (CRRT) using a set of criteria improves outcomes. These criteria are based on the best available evidence. In a systematic review, aside from urine output, there was no one factor that predicted successful weaning of RRT in patients with AKI. Urine output prior to discontinuation of RRT was the most commonly described and robust predictor. The pooled analysis found a sensitivity of 66.2% and specificity of 73.6% for urine output to predict successful RRT discontinuation. Patients with AKI on CRRT recruited during the first half of the study will be controls (usual process of care). After accrual, patients recruited for the second half will receive the intervention where discontinuation of CRRT will be guided by a set of criteria based on the patient's hemodynamic status and other factors.
详细描述
To the investigator's knowledge, no study has evaluated the impact of a standardized approach to de-escalation of Continuous Renal Replacement Therapy (CRRT) in patients with AKI. Exposure to more frequent and higher intensity RRT has been associated with delayed renal recovery. There is scant evidence in the literature on benefit or harm associated with a standardized approach to de-escalation of CRRT on the outcomes of successful weaning of CRRT, impact on CRRT duration, renal recovery, safety and adverse events. Thus, this generates a clinical equipoise. Therefore, this study should help guide nephrologists and intensivists on the appropriate management of CRRT in patients with AKI.
This is a prospective quasi-experimental (before-after) study of patients with acute kidney injury requiring continuous renal replacement therapy in the intensive care unit. It will be based on Good Clinical Practice Standards and performed under IRB supervision. This will be a quasi-experimental study design due to the nature of the intervention and the processes of care leading to making a clinical decision. Patients with AKI on CRRT will be prospectively recruited. Patients recruited during the first half of the study will be in the control arm where usual process of care will not be altered. After accrual, patients recruited for the second half will receive the intervention where discontinuation of CRRT will be guided by a set of criteria based on the patient's hemodynamic status and other factors. A decision tree form would be filled by one of the team members each day. This will increase adherence to the protocol and allow us to track reasons for not discontinuing CRRT when it is suggested to do so.
Patients will be approached within 24-36 hours of starting CRRT. Patients will be eligible for trial entry after the decision is made to pursue CRRT. Patients with provided informed consent will be accrued in the study.
The hypothesis is that the intervention arm will lead to earlier discontinuation of CRRT. This may translate to less treatment-associated adverse events, namely intradialytic hypotension, and potentially improve the chance of renal recovery. Investigators will collect data on persistent kidney dysfunction at 30 days after AKI as defined by persistent need for RRT or doubling of baseline creatinine.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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
- 未提供
排除标准
- 未提供
结局指标
主要结局
Successful discontinuation of Continuous Renal Replacement Therapy
时间窗: 7 consecutive days post last CRRT performed
Successful discontinuation of CRRT is defined by being free from any form of renal replacement therapy for at least 7 consecutive days. We will measure the difference in the proportion of participants who achieve successful discontinuation of CRRT between the two groups.
次要结局
- Major adverse kidney events (MAKE30)(Up to 30 days)
- Adverse events occurring within 7 days after discontinuation of CRRT(Within 7 days post DC CRRT)
- Intermittent hemodialysis after CRRT discontinuation(Within 7 days post DC CRRT)
- CRRT duration(1 to 100 days)
研究者
Khaled Shawwa
Assistant Professor
West Virginia University
