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Not yet recruitingNCT07837219CRRT-AFUpdated Sep 28, 2026

Frailty and Outcomes in Critically Ill Patients Receiving CRRT

An observational study in Acute Kidney Injury, sponsored by Karolinska Institutet. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-28.

Sponsored by Karolinska Institutet · Observational

Updated Sep 28, 2026Eligibility revisedTitle changedGo to Updates ↓
Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
22,000
Ages
18 Years and older
Sex
All
01

Study summary

This nationwide observational cohort study will investigate the association between frailty, chronological age, and clinical outcomes in critically ill patients receiving continuous renal replacement therapy (CRRT) in Sweden. Using data from the Swedish Intensive Care Registry, the study will assess whether the Clinical Frailty Scale (CFS) and other measures of comorbidity and illness severity provide prognostic information beyond chronological age. Outcomes will include 30-day mortality, intensive care unit length of stay, and mortality at 60, 90, and 365 days following intensive care unit (ICU) admission. The study aims to contribute to more individualized assessment of critically ill patients who may require CRRT.

Read the detailed description

This is a nationwide, registry-based observational cohort study of critically ill patients treated in intensive care units in Sweden. The study will use data from the Swedish Intensive Care Registry (SIR), which collects information from intensive care units across Sweden.

The primary focus is on critically ill patients receiving continuous renal replacement therapy (CRRT), with particular emphasis on older patients and the prognostic role of frailty. The study will investigate whether the Clinical Frailty Scale (CFS) and measures of comorbidity and illness severity provide prognostic information beyond chronological age.

The cohort will include eligible adult intensive care unit patients receiving continuous renal replacement therapy during their ICU stay. Baseline characteristics, including age and sex, will be assessed at ICU admission. Illness severity will be described using the Simplified Acute Physiology Score 3 (SAPS3), including estimated mortality risk. Additional variables will include comorbidities, ICU admission characteristics, discharge diagnosis, and CRRT-related treatment information available in the registry.

Mortality follow-up will be conducted through available registry data and linkage to the Swedish Cause of Death Register. Outcomes will be assessed at predefined time points, including 30, 60, 90, and 365 days following intensive care unit admission.

The study is observational and registry-based. Investigators will not assign continuous renal replacement therapy treatment or perform research procedures on patients. Statistical analyses will include descriptive methods, survival analyses, and multivariable regression to evaluate associations between frailty, age, illness severity, and clinical outcomes.

02

Conditions studied

  • Acute Kidney Injury

Keywords

  • Continuous renal replacement therapy
  • CRRT
  • Critical illness
  • Clinical Frailty Scale
  • Frailty
  • Older adults
  • Intensive care
  • Acute kidney injury
  • Mortality
  • Intensive care unit length of stay
  • SAPS3
  • Swedish Intensive Care Registry
03

In context

Acute Kidney Injury

1,691 studies on the registry are indexed under Acute Kidney Injury; 395 are open to participants now.

This study's planned enrollment of 22,000 is above the median of 160 across 814 observational studies indexed under Acute Kidney Injury.

Browse Acute Kidney Injury studies →

Lead sponsor

Karolinska Institutet is the lead sponsor of 1,148 studies on the registry; 276 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

The criteria were revised on the registry on Sep 28, 2026. See what changed

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Adult patients (aged ≥18 years) admitted to Swedish intensive care units and receiving continuous renal replacement therapy (CRRT) during their ICU stay between January 1, 2012, and August 15, 2024. Patients will be identified through the Swedish Intensive Care Registry (SIR). The study focuses on the association between age, frailty, illness severity, and clinical outcomes, including mortality and ICU length of stay. Clinical Frailty Scale data will be used when available, with mortality follow-up for up to 365 days after ICU admission.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients aged 18 years or older.
  • Patients treated in an intensive care unit in Sweden.
  • Patients receiving continuous renal replacement therapy (CRRT) during the ICU stay.
  • ICU admissions occurring between January 1, 2012, and December 31, 2026, subject to confirmation of the final study period.

Exclusion criteria

Exclusion Criteria:

  • Age below 18 years.
  • No treatment with CRRT during the ICU stay. Concealed or temporary personal identity number. Invalid registration date of death. Emigration within 30 days after ICU admission. Missing SAPS3 score.
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
22,000 participants (estimated)
Patient registry
No

Groups and cohorts

  • Critically ill patients with AKI and need for CRRT

    Critically ill patients with AKI and need for (the intervention) CRRT

06

What researchers measure

Primary outcomes

  1. 30-day mortality

    All-cause mortality assessed following ICU admission using mortality data available through the Swedish Intensive Care Registry and registry linkage.

    Time frame: Within 30 days after ICU admission.

Secondary outcomes

  1. Intensive care unit length of stay

    Duration of ICU stay, assessed using registry data.

    Time frame: During the index ICU admission.

  2. 60-day mortality

    60-day all-cause mortality following ICU admission.

    Time frame: Within 60 days after ICU admission.

  3. 90-day mortality

    All-cause mortality following ICU admission.

    Time frame: Within 90 days after ICU admission.

  4. 365-day mortality

    All-cause mortality following ICU admission

    Time frame: Within 365 days after ICU admission.

07

Study locations

No study locations are listed for this record.

08

References and documents

Individual participant data

Plan to share: No — Individual participant data will not be made publicly available because the study uses sensitive registry data obtained from the Swedish Intensive Care Registry and national Swedish health and population registers. Data sharing is subject to applicable ethical approvals, data protection legislation, and the terms and conditions of the relevant data controllers. Aggregated results may be shared through scientific publications and presentations.

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Eligibility
2 inclusion criteria edited, 2 added; 1 exclusion criterion edited, 1 added
What changed in the criteria
Inclusion criteria
  • AddedPatients aged 18 years or older.
  • AddedPatients treated in an intensive care unit in Sweden.
  • EditedPatients aged 18 years or older. Patients treated in an intensive care unit in Sweden. Patients receiving continuous renal replacement therapy (CRRT) during the ICU stay.
  • EditedICU admissions occurring between January 1, 2012, and August 15December 31, 20242026, subject to confirmation of the final study period.
Exclusion criteria
  • AddedAge below 18 years.
  • EditedAge below 18 years. No treatment with CRRT during the ICU stay. Concealed or temporary personal identity number. Invalid registration date of death. Emigration within 30 days after ICU admission. Missing SAPS3 score.
Sep 28, 2026
Title
Frailty and Outcomes in Critically Ill Patients Receiving Continuous Renal Replacement Therapy: A Nationwide Swedish Cohort StudyCRRT
Sep 28, 2026
Show all 1 update
  1. Sep 28, 2026
    Eligibility 2 inclusion criteria edited, 2 added; 1 exclusion criterion edited, 1 added
    What changed in the criteria
    Inclusion criteria
    • AddedPatients aged 18 years or older.
    • AddedPatients treated in an intensive care unit in Sweden.
    • EditedPatients aged 18 years or older. Patients treated in an intensive care unit in Sweden. Patients receiving continuous renal replacement therapy (CRRT) during the ICU stay.
    • EditedICU admissions occurring between January 1, 2012, and August 15December 31, 20242026, subject to confirmation of the final study period.
    Exclusion criteria
    • AddedAge below 18 years.
    • EditedAge below 18 years. No treatment with CRRT during the ICU stay. Concealed or temporary personal identity number. Invalid registration date of death. Emigration within 30 days after ICU admission. Missing SAPS3 score.
    Title Frailty and Outcomes in Critically Ill Patients Receiving Continuous Renal Replacement Therapy: A Nationwide Swedish Cohort StudyCRRT
    + 1 other change: description

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07837219
Responsible party
Max Bell (Associate Professor, Senior Lecturer, Karolinska Institutet) — Principal investigator
First posted
Sep 23, 2026
Start date
Nov 1, 2026 (estimated)
Primary completion
Dec 31, 2028 (estimated)
Completion
Dec 31, 2028 (estimated)
Last update
Sep 28, 2026

Study contacts

Max Bell, MD, PhD
Contact
max.bell@regionstockholm.se
+46708278533
Max Bell, MD, PhD
principal investigator · Karolinska Institutet

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.

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