NCT04221932

Brief Summary

Acute kidney replacement therapy (i.e., dialysis) is used in 6-10% of patients admitted to intensive care units (ICUs). The amount of acute kidney replacement therapy use has increased in Canadian ICUs over the last several years. Continuous renal replacement therapy (CRRT) remains the most common form of acute renal replacement therapy used in ICUs. Many different parts aspects of CRRT lack a usual way to be done, and because of this, are done differently in different ICUs. Not having generally accepted markers of the performance and delivery of CRRT is a main reason that we have these practice difference. This is an important gap in the way that clinicians deliver this important ICU therapy and is a main focus of ongoing research in ICU and dialysis. The proposed project is a continuation of a program of work that first reviewed the current state of the quality and safety in ICU and dialysis. Then, a systematic review of all potential quality markers was done to see what options for measures were possible. Next, following a meeting of leaders of dialysis in the ICU, the most important of these measures were ranked to decide which ones could be used in monitoring CRRT for patients.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
945

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2022

Typical duration for all trials

Geographic Reach
1 country

14 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 6, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 9, 2020

Completed
2.5 years until next milestone

Study Start

First participant enrolled

July 5, 2022

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

March 30, 2025

Status Verified

March 1, 2025

Enrollment Period

2.5 years

First QC Date

January 6, 2020

Last Update Submit

March 25, 2025

Conditions

Keywords

Intensive Care UnitCritical IllnessAcute Kidney InjuryContinuous Renal Replacement TherapyQuality Improvement

Outcome Measures

Primary Outcomes (1)

  • Quality of CRRT performance and delivery

    Quarterly changes in the performance of the CRRT KPIs following the initiation of CRRT KPI reporting and our multi-faceted quality assurance and improvement knowledge translational intervention. The specific CRRT KPIs will include, but will not necessarily be limited to, 1) CRRT leadership; 2) CRRT education; 3) average filter life measured in hours; 4) downtime in percentage of treatment time lost; 5) average dose prescribed and delivered in ml/kg/hr; 6) alarms in number/day/machine; 7) significant adverse events as per number of reporting \& learning system (RLS) records/month; and 8) ICU mortality. Based on the vanguard phase there may be additional or further refined KPIs to consider. These outcomes will be recorded on a continual quarterly basis to determine the predicted slope change impact following the implementation of our intervention.

    2 years post intervention

Secondary Outcomes (2)

  • Economic Evaluation

    3 years post intervention

  • Patient-centred Outcomes

    3 years post intervention

Study Arms (2)

Pre Intervention

Retrospective evaluation of data from 2 years prior to the implementation of our CRRT KPI reports. This will include approximately 1500 participants.

Device: CRRT KPI Reports

Post Intervention

This will be a prospective evaluation of all new ICU patients receiving CRRT in Alberta over a 2 year periods. This will include approximately 1500 participants

Device: CRRT KPI Reports

Interventions

This will involve the regular report of CRRT KPI reports across the CRRT programs across the province. It will also include standardization of CRRT practices across Alberta. Reports will include those for the program (i.e., structure), device (i.e., process) and patient outcomes (i.e., outcomes).

Post InterventionPre Intervention

Eligibility Criteria

Age1 Year+
Sexall(Gender-based eligibility)
Gender Eligibility DetailsIt is imperative that sex and gender be considering and explored in any health services program. Gender identification will not be captured in this work. However, sex will be evaluated in QUALITY CRRT. QUALITY CRRT will include all patients, both men and women, receiving CRRT in adult ICUs in Alberta in an unbiased fashion through our current and future CISs, eCritical and ConnectCareâ„¢, respectively. Our analyses will be stratified by sex to explore if there is a difference in CRRT treatment and quality by sex. Further, it is recognized that there is a biological sex and gender identity gap in health research. To help address this gap, we will ensure that 50% of all research executive, steering committee and quality monitoring committee members are women. QUALITY CRRT will also consider sex/gender in the planning, conduct and dissemination of all aspects of QUALITY CRRT.
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All Alberta critically ill patients requiring CRRT.

You may qualify if:

  • ICU admission
  • CRRT initiation

You may not qualify if:

  • \- None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (14)

Alberta Children's Hospital

Calgary, Alberta, Canada

Location

Foothills Medical Centre

Calgary, Alberta, Canada

Location

Peter Lougheed Centre

Calgary, Alberta, Canada

Location

Rockyview General Hospital

Calgary, Alberta, Canada

Location

South Health Campus

Calgary, Alberta, Canada

Location

Misericordia Community Hospital

Edmonton, Alberta, Canada

Location

Royal Alexandra Hospital

Edmonton, Alberta, Canada

Location

Stollery Childrens Hospital

Edmonton, Alberta, Canada

Location

University of Alberta Hospital

Edmonton, Alberta, Canada

Location

Chinook Regional Hospital

Lethbridge, Alberta, Canada

Location

Red Deer Regional Hospital

Red Deer, Alberta, Canada

Location

Sturgeon Community Hospital

St. Albert, Alberta, Canada

Location

Grey Nuns Community Hospital

Edmonton, Albert, Canada

Location

Mazankowski Alberta Heart Institute

Edmonton, Albert, Canada

Location

Related Publications (1)

  • Opgenorth D, Reil E, Lau V, Fraser N, Zuege D, Wang X, Bagshaw SM, Rewa O. Improving the quality of the performance and delivery of continuous renal replacement therapy (CRRT) to critically ill patients across a healthcare system: QUALITY CRRT: a study protocol. BMJ Open. 2022 Feb 4;12(2):e054583. doi: 10.1136/bmjopen-2021-054583.

MeSH Terms

Conditions

Critical IllnessAcute Kidney Injury

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • Oleksa G Rewa, MD MSc

    University of Alberta

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 6, 2020

First Posted

January 9, 2020

Study Start

July 5, 2022

Primary Completion

December 31, 2024

Study Completion

December 31, 2024

Last Updated

March 30, 2025

Record last verified: 2025-03

Locations