NCT07837219

Brief 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.

Trial Health

65
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
22,000

participants targeted

Target at P75+ for all trials

Timeline
26mo left

Started Nov 2026

Typical duration for all trials

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 17, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 23, 2026

Completed
1 month until next milestone

Study Start

First participant enrolled

November 1, 2026

Expected
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2028

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2028

Last Updated

September 28, 2026

Status Verified

September 1, 2026

Enrollment Period

2.2 years

First QC Date

September 17, 2026

Last Update Submit

September 23, 2026

Conditions

Keywords

Continuous renal replacement therapyCRRTCritical illnessClinical Frailty ScaleFrailtyOlder adultsIntensive careAcute kidney injuryMortalityIntensive care unit length of staySAPS3Swedish Intensive Care Registry

Outcome Measures

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.

    Within 30 days after ICU admission.

Secondary Outcomes (4)

  • Intensive care unit length of stay

    During the index ICU admission.

  • 60-day mortality

    Within 60 days after ICU admission.

  • 90-day mortality

    Within 90 days after ICU admission.

  • 365-day mortality

    Within 365 days after ICU admission.

Study Arms (1)

Critically ill patients with AKI and need for CRRT

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

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Acute Kidney InjuryCritical IllnessFrailty

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Max Bell, MD, PhD

    Karolinska Institutet

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor, Senior Lecturer

Study Record Dates

First Submitted

September 17, 2026

First Posted

September 23, 2026

Study Start (Estimated)

November 1, 2026

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

December 31, 2028

Last Updated

September 28, 2026

Record last verified: 2026-09

Data Sharing

IPD Sharing
Will not share

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.