Insights Into the Continuous Renal Replacement Therapy to Critical Ill Patients

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorUniversity of Alberta

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Admission to an intensive care unit

CRRT therapy

Disqualifiers

End-stage kidney disease

CRRT <24 hours

Trial population

Patients with new acute kidney injury and initiation of continuous renal replacement therapy who are admitted to an intensive care unit and who have received continuous renal replacement therapy for at least 24 hours will be eligible for this study.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • continuous renal replacement therapy

    Device

    We will include any critically ill patient admitted to an intensive care unit requiring dialysis

Treatment groups

100,000 Participants
are divided into 1 treatment group
Group A: Patients1 intervention

Trial outcomes

Primary outcomes

1

Mortality

Patient survival at the time of ICU discharge

Time frame
Up to 28 days

Secondary outcomes

1

Hospital mortality

Patient survival status during their hospitalization

Time frame
Up to 90 days
2

ICU length of stay

Duration of ICU stay

Time frame
Up to 90 days
3

Hospital length of Stay

Duration of hospital stay

Time frame
Up to 90 days
4

Renal recovery

1\) Return of serum creatinine (SCr) to within 50% of baseline; 2) no longer receiving dialysis

Time frame
Up to 90 days

Other outcomes

1

Health Related Quality of Life

Health Related Quality of Life (EQ-5D-5L) "EuroQol 5-Dimension 5-Level" questionnaire.

Time frame
90 and 365 days
2

Health Economic Analysis

ICU and Hospital Costs

Time frame
Up to 90 days

Sponsors and contacts

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University of Alberta

Lead sponsor

University of Alabama at Birmingham

Collaborator

University of Zagreb

Collaborator

This trial is not recruiting at the moment. You can still explore other options: