跳至主要内容
临床试验/NCT07365111
NCT07365111尚未招募不适用

Insights Into the Characteristics, Prescription and Delivery of Continuous Renal Replacement Therapy to Critical Ill Patients - The iCRRT Data Registry

University of Alberta1 个研究点 分布在 1 个国家目标入组 100,000 人开始时间: 2027年3月31日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
100,000
试验地点
1
主要终点
Mortality

研究概览

简要总结

This is a multinational, prospective, observational study designed to characterize patient demographics, prescription parameters, and process measures of continuous renal replacement therapy (CRRT) in intensive care units (ICUs) worldwide. The study aims to examine similarities and differences in CRRT practices and outcomes among critically ill adult patients across a global network of medical centers.

The goal is to develop a large, comprehensive repository of data on CRRT practices and outcomes. This repository will enable characterization of variation in standard CRRT practices across medical centers. Natural variability in practice patterns-both between and within centers-will provide an opportunity to compare outcomes associated with different approaches and to generate high-quality preliminary data to inform future interventional trials.

Primary Objective

- To describe global patient characteristics, CRRT modalities, and clinical outcomes among patients receiving CRRT.

Secondary Objectives

  • To compare clinical outcomes across geographic regions and CRRT modalities.
  • To identify patient-level and practice-level predictors of outcomes.
  • To assess the impact of comorbid conditions (e.g., diabetes mellitus) on CRRT outcomes.

Exploratory Objectives

  • To evaluate long-term renal outcomes and patient-reported quality of life.
  • To explore health economics and resource utilization related to CRRT.

Study Population All patients receiving CRRT as part of routine clinical care in the ICU at participating centers will be eligible for inclusion.

Data Collection The study will support an epidemiological assessment of patients undergoing CRRT, including, but not limited to, demographics, underlying disease states, severity of illness, physiological support, indications for CRRT, and clinical outcomes. Outcomes of interest include ICU and hospital mortality, ICU and hospital length of stay, and renal recovery.

详细描述

1.0 Rationale The goal of this study is to develop a large repository of data on CRRT practices and outcomes, enabling characterization of similarities and differences in standard CRRT practices across medical centers. Natural variability in practices will provide an opportunity to compare outcomes associated with different practice patterns and generate important preliminary data to inform future interventional trials.

2.0 Background Despite the accumulation of high-quality evidence, the prescription, delivery, and maintenance of continuous renal replacement therapy (CRRT) remain highly variable across clinical settings. This persistent heterogeneity reflects uncertainty in key aspects of CRRT practice and underscores the need for a comprehensive, international evaluation. The international CRRT (iCRRT) initiative was established to systematically characterize global CRRT practices, identify regional variation, and inform strategies to optimize the delivery of this life-sustaining therapy for critically ill patients.

Acute kidney injury (AKI) is among the most common and severe complications encountered in critical illness, affecting more than half of patients admitted to intensive care units (ICUs). Approximately 6% of ICU patients require renal replacement therapy (RRT), a subgroup in whom hospital mortality remains exceedingly high, frequently approaching or exceeding 50%. Although AKI is associated with substantial morbidity, mortality, and healthcare utilization, no interventions have been shown to consistently reverse established kidney injury. Management, therefore, remains largely supportive, with RRT reserved for patients with advanced or refractory disease.

For critically ill patients, particularly those with hemodynamic instability, CRRT has become the predominant RRT modality in many high-income countries. Since the original description of continuous arteriovenous hemofiltration more than three decades ago, technological and procedural advances have transformed CRRT into a widely adopted and routinely applied therapy. Compared with intermittent hemodialysis (IHD), CRRT offers superior hemodynamic tolerance, continuous solute control, and more precise fluid management. These perceived advantages form the basis of the 2012 Kidney Disease Improving Global Outcomes (KDIGO) guidelines, which recommend CRRT over intermittent modalities in hemodynamically unstable patients . Nevertheless, despite its central role in contemporary critical care, substantial variation in CRRT practice persists across institutions and individual providers.

At the same time, there is increasing recognition that traditional clinical outcomes alone may incompletely capture the impact of critical illness and its treatments. Evidence increasingly supports the routine use of patient-reported outcome measures (PROMs) to improve patient-clinician communication, enhance patient satisfaction, and positively influence health-related quality of life (HRQL). In this context, the Alberta-based EMPATHY study is evaluating the effectiveness and cost-effectiveness of systematic PROMs collection in chronic RRT programs, examining associations with patient experience, clinical outcomes, HRQL, and healthcare utilization.

研究设计

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

入排标准

性别
All
接受健康志愿者

入选标准

  • Admission to an intensive care unit
  • CRRT therapy

排除标准

  • End-stage kidney disease
  • CRRT <24 hours

研究组 & 干预措施

Patients

Any patients admitted to the ICU and required CRRT

干预措施: continuous renal replacement therapy (Device)

结局指标

主要结局

Mortality

时间窗: Up to 28 days

Patient survival at the time of ICU discharge

次要结局

  • Hospital mortality(Up to 90 days)
  • ICU length of stay(Up to 90 days)
  • Hospital length of Stay(Up to 90 days)
  • Renal recovery(Up to 90 days)
  • Adverse events(Up to 90 days)

研究者

申办方类型
Other
责任方
Sponsor
主要研究者

Oleksa Rewa

Associate Professor, Director of Research & Innovation

University of Alberta

研究点 (1)

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