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临床试验/NCT07317362
NCT07317362已完成不适用

Predictive Score for the Success of Discontinuation of Renal Replacement Therapy (RRT) in Intensive Care

Assistance Publique - Hôpitaux de Paris1 个研究点 分布在 1 个国家目标入组 5,976 人开始时间: 2025年11月19日最近更新:

试验速览

阶段
不适用
状态
已完成
入组人数
5,976
试验地点
1
主要终点
Successful weaning from renal replacement therapy

研究概览

简要总结

The goal of this observational study is to evaluate when renal replacement therapy (RRT) can be safely discontinued in intensive care unit (ICU) patients with acute kidney injury (AKI). The main question it aims to answer is:

Can the UNDERSCORE predictive score accurately identify ICU patients with AKI who can successfully stop RRT without needing restart or experiencing early death?

Using routinely collected clinical data from the AP-HP Health Data Warehouse, the study will follow ICU patients with AKI treated with RRT to assess whether the UNDERSCORE score predicts successful RRT discontinuation within 7 days.

详细描述

Background and Rationale

Acute kidney injury (AKI) is a frequent and severe complication among patients admitted to intensive care units (ICUs), and it is associated with high morbidity, mortality, prolonged length of stay, and long-term renal impairment. In cases of severe AKI, renal replacement therapy (RRT), also referred to as extracorporeal renal replacement therapy (EER), remains the only effective supportive treatment capable of correcting life-threatening metabolic disturbances such as hyperkalemia, metabolic acidosis, fluid overload, and uremia.

Over the last decade, substantial progress has been made in defining optimal strategies for initiating RRT. Large randomized controlled trials, including AKIKI, IDEAL-ICU, and STARRT-AKI, have demonstrated that in the absence of immediate life-threatening complications, a conservative or "watchful waiting" strategy is safe and avoids unnecessary exposure to RRT in a significant proportion of patients. As a result, delayed initiation strategies have become standard of care in many ICUs.

In contrast, the question of when and how to discontinue RRT once renal function begins to recover remains insufficiently addressed. Current clinical practice regarding RRT discontinuation is highly heterogeneous and largely based on individual clinician judgment rather than objective, validated criteria. Prolonging RRT beyond what is necessary may expose patients to avoidable complications, including catheter-related infections, bleeding related to anticoagulation, hemodynamic instability, thrombosis, and nutritional losses, while also increasing healthcare costs and resource utilization.

International guidelines, including those from KDIGO, explicitly acknowledge the lack of evidence-based criteria for stopping RRT and highlight the need for reliable markers to predict successful weaning. Previous studies that attempted to identify predictors of successful RRT discontinuation were conducted before conservative initiation strategies became standard practice and often included patients who may not have had a validated indication for RRT. Moreover, these studies varied widely in terms of timing of assessment (during RRT, immediately after cessation, or days later), further limiting their applicability.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

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

  • Patients admitted to the intensive care unit with severe acute kidney injury (defined as KDIGO stage 2 or 3) who received renal replacement therapy (RRT).

排除标准

  • Patients under the age of 18, those without electronical medical record

结局指标

主要结局

Successful weaning from renal replacement therapy

时间窗: 7 days

absence of RRT resumption or death within 7 days

次要结局

  • 28-day mortality(28 days from RRT weaning attempt)
  • Renal function recovery(7 days from RRT weaning attempt)
  • 60 day-mortality(Death within 60 days of RRT weaning attempt)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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