Timing of Renal Replacement Therapy in the Critically Ill Patients

NCT03629977 | Recruiting

• 1 other identifier: KarolinskaUH_KING
• Study Type: observational
• Target: 50,000
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Mortality

  Date of death

  90-day mortality (mortality within 90 days of intensive care unit admission)

Secondary Outcomes (4)

• ICU Length of Stay (LOS)

  We will measure ICU LOS from ICU admission to ICU discharge, within 30 days of admission

• Hospital LOS

  We will measure Hospital LOS from ICU admission to hospital discharge, within 60 days of admission

• End Stage Renal Disease

  ESRD from 90 days after ICU discharge up to a maximum of 10 years

• Mortality at other specified time-points

  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

  90-day-follow-up; counting the days within the ICU stay on invasive ventilation

Study Arms (3)

early RRT

A patient where initiation of RRT is started without the absolute indications

Device: CRRT

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)

Device: CRRT

never RRT

RRT is never started, matched against early RRT group.

Device: CRRT

Interventions

CRRT DEVICE

Continuous Renal Replacement Therapy

early RRT; late RRT; never RRT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• \*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

You may not qualify if:

• Patients \<18 years
• Patients with DNAR (do not attempt resuscitation)-orders
• Patients dying within 12 hours of commencing renal replacement therapy.

Sponsors & Collaborators

• Karolinska University Hospital: lead

Study Sites (1)

Karolinska University Hospital

Stockholm, 17176, Sweden

RECRUITING

MeSH Terms

Conditions

Acute Kidney Injury; Uremia; Edema; Critical Illness

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Disease Attributes; Pathologic Processes

Study Officials

• Max Bell, MD, PhD

  Karolinska Institutet

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Max Bell, MD, PhD

CONTACT

+46708278533; max.bell@sll.se

Claire Rimes-Stigare, MD, PhD

CONTACT

+46733911087; claire.rimes-stigare@sll.se

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Year
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD, Associate Professor

Study Record Dates

• First Submitted: February 20, 2018
• First Posted: August 14, 2018
• Study Start: November 1, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): April 1, 2027
• Last Updated: September 3, 2025

Record last verified: 2025-08

Locations

SE (1)