Timing of Renal Replacement Therapy in the Critically Ill Patients
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorKarolinska University Hospital
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
Patients <18 years
Patients with DNAR (do not attempt resuscitation)-orders
Patients dying within 12 hours of commencing renal replacement therapy.
Trial population
ICU patients treated in Stockholm between 2007 and 2017 in the following five ICUs from three hospitals: Karolinska University Hospital in Solna - central medico-surgical ICU; Karolinska University Hospital in Solna - cardiothoracic ICU; Karolinska University Hospital Huddinge - medico-surgical ICU; Södersjukhuset Hospital - medical ICU; Södersjukhuset Hospital - surgical ICU.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
CRRT
DeviceContinuous Renal Replacement Therapy
Treatment groups
50,000 Participants
are divided into 3 treatment groupsGroup A: early RRT1 intervention
Group B: late RRT1 intervention
Group C: never RRT1 intervention
Trial outcomes
Primary outcomes
1
Mortality
Date of death
Time frame
90-day mortality (mortality within 90 days of intensive care unit admission)Secondary outcomes
1
ICU Length of Stay (LOS)
Number of days in ICU
Time frame
We will measure ICU LOS from ICU admission to ICU discharge, within 30 days of admission2
Hospital LOS
Number of days in hospital
Time frame
We will measure Hospital LOS from ICU admission to hospital discharge, within 60 days of admission3
End Stage Renal Disease
Date of ESRD, from the Swedish Renal Register
Time frame
ESRD from 90 days after ICU discharge up to a maximum of 10 years4
Mortality at other specified time-points
Date of death
Time frame
30-, 60-, 180-, 1-year, 2-year and 3-year mortality (mortality within those time points of intensive care unit admission)Other outcomes
1
Days on ventilator
Number of days on invasive ventilation
Time frame
90-day-follow-up; counting the days within the ICU stay on invasive ventilationSponsors and contacts
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Source ClinicalTrials.gov