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NCT Number: NCT07837219

Frailty and Outcomes in Critically Ill Patients Receiving Continuous Renal Replacement Therapy: A Nationwide Swedish Cohort Study

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 ICU admission. The study aims to contribute to more individualized assessment of critically ill patients who may require CRRT.

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Key information

About this study

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 ICU patients receiving CRRT 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 ICU admission.

The study is observational and registry-based. Investigators will not assign CRRT 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 August 15, 2024, subject to confirmation of the final study period.

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.

Treatment and study plan

Primary outcomes

  1. 30-day mortality

    Time frame: Within 30 days after ICU admission.

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

Secondary outcomes

  1. Intensive care unit length of stay

    Time frame: During the index ICU admission.

    Duration of ICU stay, assessed using registry data.

  2. 60-day mortality

    Time frame: Within 60 days after ICU admission.

    60-day all-cause mortality following ICU admission.

  3. 90-day mortality

    Time frame: Within 90 days after ICU admission.

    All-cause mortality following ICU admission.

  4. 365-day mortality

    Time frame: Within 365 days after ICU admission.

    All-cause mortality following ICU admission

Study contacts

Contact information is provided by the study sponsor or research team.

Max Bell, MD, PhD

CONTACT

[email protected]

+46708278533

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Registry information

Official study title

Continuous Renal Replacement Therapy in the Aging and Frail Critically Ill Patient (CRRT-AF): A Nationwide Population-Based Cohort Study of Frailty, Age, and Clinical Outcomes

Acronym: CRRT-AF

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Sep 23, 2026
Registry last updated
Sep 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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