Comparison of Patient Outcomes Between Retrospective Prismaflex HF20 Set and Historical Prospective Pediatric Continuous Renal Replacement Therapy (ppCRRT) Registry
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 59
- 试验地点
- 5
- 主要终点
- Survival to CRRT discontinuation
研究概览
简要总结
A retrospective multicenter, observational design intended to capture data on pediatrics (weighing between 8 - 20 kg) who underwent continuous renal replacement therapy (CRRT) using the HF20 set. Data will be compared with a similar population (weighting 8-20 kg) from the ppCRRT registry who received CRRT with Prismaflex M60 sets.
详细描述
This study aims to compare patient outcomes after treatment with HF20 based CRRT to the historical ppCRRT registry. Data from eligible patient records will be collected, starting from January 2008 to most recent in Canada and from January 2020 to most recent in the US.
The ppCRRT registry used a prospective observational format whereby de-identified data on patients and CRRT circuits were collected from 13 participating centers across the US between 2001 JAN 01 and 2005 AUG 31. The registry's primary outcome measure was patient survival to ICU discharge.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient weighed between 8 and 20 kg (17.6 - 44.1 lb).
- •Patient received medical care in an intensive care unit (ICU) and was treated with HF20 based CRRT.
- •Patient had a clinical diagnosis of AKI or ARF or fluid overload requiring CRRT.
- •Note: The cohort of patients treated with M60 sets from the ppCRRT registry (weighing 8 - 20 kg) are to meet inclusion criteria 1 and 3.
排除标准
- •There are no exclusion criteria for this study.
研究组 & 干预措施
Prismaflex HF20 cohort
Data collected from this study
Pediatrics (weighing between 8 and 20 kg) who received CRRT with Prismaflex HF20 between 2008 to current in Canada or between 2020 to current in the US
干预措施: Prismaflex HF20 (Device)
结局指标
主要结局
Survival to CRRT discontinuation
时间窗: From CRRT initiation up to CRRT discontinuation of the first record of CRRT treatment with HF20/M60 (from January 2008 to present in Canada, and from January 2020 to present in the US)
The proportion of patients who completed HF20/M60 based CRRT
Survival to ICU discharge
时间窗: From ICU admission up to ICU discharge as related to of the first record of CRRT treatment with HF20/M60 (from January 2008 to present in Canada, and from January 2020 to present in the US)
The proportion of patients who were released from the ICU
次要结局
- ICU length of stay(From ICU admission up to ICU discharge as related to of the first record of CRRT treatment with HF20/M60 (from January 2008 to present in Canada, and from January 2020 to present in the US))
- CRRT duration(From CRRT initiation up to CRRT discontinuation of the first record of CRRT treatment with HF20/M60 (from January 2008 to present in Canada, and from January 2020 to present in the US))
- AEs of relevance for HF20(From CRRT initiation up to CRRT discontinuation of the first record of CRRT treatment with HF20 (from January 2008 to present in Canada, and from January 2020 to present in the US))