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临床试验/NCT07447791
NCT07447791招募中不适用

WISDOM UK: Low Dose-intensity Versus Standard Dose-intensity Continuous Renal Replacement Therapy in Critically Ill Patients: a Randomized Trial

Guy's and St Thomas' NHS Foundation Trust1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2025年2月15日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
入组人数
20
试验地点
1
主要终点
total delivered effluent rate

研究概览

简要总结

Acute kidney injury is a potentially life threatening condition which affects 1 in 2 patients in the Intensive Care Unit (ICU). Patients often need dialysis treatment, also called renal replacement therapy. Renal replacement therapy is a treatment that removes toxins and excess fluid from the blood stream. It consists of having a small plastic catheter in a vein in the neck or in the groin through which blood flows through a dialysis machine and is cleansed and excess water is removed. The cleansed blood is then returned to the patient via the same catheter.

One of the major areas of uncertainty for doctors in the ICU is "What is the right intensity of renal replacement therapy for patients with acute kidney injury?" A higher intensity indeed removes more toxins but also removes other substances in the blood, including vitamins, nutrients and important medications. The current usual dose is around 25 ml/kg/hr but clinical practice in the UK is very variable and some patients routinely receive higher doses and some get lower doses. Data from large databases worldwide have suggested that a lower dose is safe and effective and may potentially allow the kidneys to recover faster but confirmation is lacking.

In this study, the investigators investigate whether renal replacement therapy at a lower intensity is as effective and safe as currently used doses. Participants will be randomised to receiving renal replacement therapy at usual or lower intensity. There will be no change to any other aspects of treatment.

The results will inform the investigators whether the study protocol is feasible and how best to design a future larger research study.

详细描述

Acute kidney injury is a potentially life threatening condition which affects 1 in 2 patients in the Intensive Care Unit (ICU). Patients often need dialysis treatment, also called renal replacement therapy. Renal replacement therapy is a treatment that removes toxins and excess fluid from the blood stream. It consists of having a small plastic catheter in a vein in the neck or in the groin through which blood flows through a dialysis machine and is cleansed and excess water is removed. The cleansed blood is then returned to the patient via the same catheter.

One of the major areas of uncertainty for doctors in the ICU is "What is the right intensity of renal replacement therapy for patients with acute kidney injury?" A higher intensity indeed removes more toxins but also removes other substances in the blood, including vitamins, nutrients and important medications. The current usual dose is around 25 ml/kg/hr but clinical practice in the UK is very variable and some patients routinely receive higher doses and some get lower doses. Data from large databases worldwide have suggested that a lower dose is safe and effective and may potentially allow the kidneys to recover faster but confirmation is lacking.

In this study, the investigators investigate whether renal replacement therapy at a lower intensity is as effective and safe as currently used doses. Participants will be randomised to receiving renal replacement therapy at usual or lower intensity. There will be no change to any other aspects of treatment.

The investigators aim to recruit 20 patients in the UK. Fully anonymised results will be shared with researchers in Canada who are conducting the same study.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Sequential
主要目的
Other
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

入选标准

  • age ≥ 18 years
  • patient weight ≥ 55 kg
  • plan to start CRRT or within 24 hours of having started CRRT for AKI
  • expected to survive and receive CRRT for a duration of ≥ 48 hours

排除标准

  • indication for sustained higher dose-intensity CRRT
  • end-stage kidney disease receiving maintenance dialysis
  • previous receipt of RRT for AKI during the current hospitalization
  • inability to comply with the requirements of the study protocol

研究组 & 干预措施

Low dose RRT

Active Comparator

dose of CRRT 10-15ml/kg/hr

干预措施: low intensity of CRRT (Procedure)

standard dose RRT

Active Comparator

usual intensity CRRT at dose determined by clinical team

干预措施: usual intensity of CRRT (Procedure)

结局指标

主要结局

total delivered effluent rate

时间窗: 7 days

difference in the total delivered effluent rate per patient

次要结局

  • Feasibility endpoints(12 months)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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