NCT03629977 Timing of Renal Replacement Therapy in the Critically Ill Patients
| NCT ID | NCT03629977 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Karolinska University Hospital |
| Condition | Acute Kidney Injury |
| Study Type | OBSERVATIONAL |
| Enrollment | 50,000 participants |
| Start Date | 2025-11-01 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 50,000 participants in total. It began in 2025-11-01 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
Inclusion Criteria: \*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 Exclusion Criteria: * Patients \<18 years * Patients with DNAR (do not attempt resuscitation)-orders * Patients dying within 12 hours of commencing renal replacement therapy.
Contact & Investigator
Max Bell, MD, PhD
PRINCIPAL INVESTIGATOR
Karolinska Institutet
Frequently Asked Questions
Who can join the NCT03629977 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Acute Kidney Injury. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT03629977 currently recruiting?
Yes, NCT03629977 is actively recruiting participants. Contact the research team at max.bell@sll.se for enrollment information.
Where is the NCT03629977 trial being conducted?
This trial is being conducted at Stockholm, Sweden.
Who is sponsoring the NCT03629977 clinical trial?
NCT03629977 is sponsored by Karolinska University Hospital. The principal investigator is Max Bell, MD, PhD at Karolinska Institutet. The trial plans to enroll 50,000 participants.
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