Early vs Late CRRT, a Propensity Matched Multicenter Cohort Study

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Observational
SUMMARY

Background: Severe acute kidney injury (AKI) among critically ill patients is sometimes treated with renal replacement therapy (RRT), and in Sweden continuous RRT (CRRT) is the dominant modality used in this population. * The optimal timing of renal replacement therapy (RRT) initiation in critically ill patients with acute kidney injury (AKI) is unknown * No consensus to guide clinical practice on this issue * Lack of consistency regarding outcome measurements; should we look at morbidity or mortality? * Wide variability in the timing of RRT initiation in the intensive care unit (ICU) population Hypothesis: This is an important knowledge gap in the support of critically ill patients with AKI and we hypothesize that early initiation of RRT is beneficial.

Methods: The present study aims to test this hypothesis by using a large scale high resolution intensive care database, the Clinisoft repository. In this database, we have information on \>60 000 patients from three different hospitals and five ICUs, during the years 2005 up until today. The repository will be crossmatched, using the unique Swedish national ID number, with hospital records; to gather information on preexisting illnesses, chronic medication and post-ICU outcomes. It is likely that over 5%, more than 3000 patients, have been treated with RRT. We will categorize these patients into early and late groups using both biomarker data and clinical data. Importantly, early and late RRT can be categorized using biomarkers, like urea and creatinine; using degree of fluid accumulation, by level of pH in blood and just by using hours-days after ICU admission. All possible definitions of early/late RRT initiation can be tested in this study. Outcomes: Our primary outcome is 90 day mortality. Secondary outcomes include: mortality at 30, 60, 180 and 365 days. Two- and three year mortality. Morbidity, measured as end-stage renal disease (ESRD) for 90-day survivors. ICU length of stay, hospital length of stay.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• \*Critically ill patients admitted to intensive care units in Stockholm at: Karolinska University Hospital (Solna and Huddinge) and at Södersjukhuset.

• \*Patients over 18 years of age

Locations
Other Locations
Sweden
Karolinska University Hospital
RECRUITING
Stockholm
Contact Information
Primary
Max Bell, MD, PhD
max.bell@sll.se
+46708278533
Backup
Claire Rimes-Stigare, MD, PhD
claire.rimes-stigare@sll.se
+46733911087
Time Frame
Start Date: 2025-11-01
Estimated Completion Date: 2027-04-01
Participants
Target number of participants: 50000
Treatments
early RRT
A patient where initiation of RRT is started without the absolute indications
late RRT
CRRT based on absolute indications.~Absolute indications:~1. hyperkalemia (serum potassium≥6 mEq/L),~2. severe acidosis (pH≤7.15),~3. plasma urea\>36 mmol/L (equals BUN=100.8 mg/dl),~4. oliguria or anuria (urine output\<0.3 ml/kg per hour for ≥24 hours or anuria for ≥12 hours), and~5. fluid overload with pulmonary edema as defined by the presence of all the following factors: (a) \>10% fluid accumulation (cumulative fluid balance/baseline weight\>10%), (b) oliguria (urine output\<0.5 ml/kg per hour for ≥12 hours), and (c) severely impaired oxygenation (PaO2/FiO2\<200 indicated by respiratory Sequential Organ Failure Assessment \[SOFA\] score≥3)
never RRT
RRT is never started, matched against early RRT group.
Related Therapeutic Areas
Sponsors
Leads: Karolinska University Hospital

This content was sourced from clinicaltrials.gov