Timing of Renal Replacement Therapy in the Critically Ill Patients

Sponsor
Karolinska University Hospital
Study ID
NCT03629977
Status
Recruiting
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Conditions

  • Acute Kidney Injury
  • Critical Illness
  • Dialysis; Complications
  • Fluid Overload
  • Uremia

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • CRRT — DEVICE
    Continuous Renal Replacement Therapy

Study Details

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.

Key Dates

First listed
Aug 14, 2018
Start date
Nov 1, 2025
Status verified
Aug 2025
Primary completion
Dec 31, 2026
Completion
Apr 1, 2027

Study Design

Enrollment
50,000 participants (estimated)

Arms

  • Arm: early RRT
    A patient where initiation of RRT is started without the absolute indications
  • Arm: 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)
  • Arm: never RRT
    RRT is never started, matched against early RRT group.

Primary Outcome Measure

Mortality [ Time Frame: 90-day mortality (mortality within 90 days of intensive care unit admission) ]

Central Contacts

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