Acute Kidney InjuryCRRT-AFNCT07837219
Frailty and Outcomes in Critically Ill Patients Receiving CRRT
An observational study of Acute Kidney Injury, run by Karolinska Institutet.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Kidney Injury
- How many people
- 22,000 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2026to 31 Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official 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
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.
- Conditions
- 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
- Medical subject headings
- Acute Kidney Injury, Critical Illness, Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Critically ill patients with AKI and need for CRRT | Critically ill patients with AKI and need for (the intervention) CRRT |
What is being measured
The primary outcome is the main question the study is designed to answer.
30-day mortality
All-cause mortality assessed following ICU admission using mortality data available through the Swedish Intensive Care Registry and registry linkage.
Measured: Within 30 days after ICU admission.
Secondary outcomes (4)
Intensive care unit length of stay
Duration of ICU stay, assessed using registry data.
Measured: During the index ICU admission.
60-day mortality
60-day all-cause mortality following ICU admission.
Measured: Within 60 days after ICU admission.
90-day mortality
All-cause mortality following ICU admission.
Measured: Within 90 days after ICU admission.
365-day mortality
All-cause mortality following ICU admission
Measured: Within 365 days after ICU admission.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2026
- Study start1 Nov 2026 (estimated)
- Primary completion31 Dec 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Kidney InjuryStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 22,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Max Bell, Karolinska Institutet
- Investigators
- Max Bell, MD, PhD, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07837219
- Sponsor's protocol ID
- CRRT-AF-001
- Acronym
- CRRT-AF
- Status last verified
- Sep 2026
- First submitted
- 17 Sep 2026
- Last updated
- 28 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07837219
- Acronym / sponsor ID
- CRRT-AF / CRRT-AF-001
- Conditions
- Acute Kidney Injury
- Keywords
- Continuous renal replacement therapy, CRRT, Critical illness, Clinical Frailty Scale, Frailty, Older adults, Intensive care, Acute kidney injury
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 22,000 participants (estimated)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 23 Sep 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Critically ill patients with AKI and need for CRRT | – | –Critically ill patients with AKI and need for (the intervention) CRRT |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
4 secondary outcomes
Intensive care unit length of stay
Time frame: During the index ICU admission.
60-day mortality
Time frame: Within 60 days after ICU admission.
90-day mortality
Time frame: Within 90 days after ICU admission.
365-day mortality
Time frame: Within 365 days after ICU admission.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2026.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Max Bell, MD, PhD principal investigator
Karolinska Institutet
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Kidney Injury, run by Karolinska Institutet.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 28 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Max Bell, MD, PhD (+46708278533, max.bell@regionstockholm.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
30-day mortality (time frame: Within 30 days after ICU admission.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2026; AzTrials last refreshed its copy on 7 Nov 2026.