Critical IllnessBRI-ICUNCT07631429
Body Roundness Index and Mortality in ICU Patients
An observational study of Critical Illness and Obesity & Overweight, run by Ondokuz Mayıs University at 1 site in Turkey (Türkiye).
Trial summary
This study investigates whether Body Roundness Index (BRI), an anthropometric measure derived from waist circumference and height, can predict mortality in adult intensive care unit (ICU) patients. BRI captures central adiposity and body fat distribution more accurately than Body Mass Index (BMI). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critical Illness, Obesity & Overweight, Mortality in Intensive Care Units
- How many people
- 550 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Aug 2026to 1 Dec 2027
- How long will I take part?
- 28 Days
- 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 admitted to the intensive care units of participating tertiary care centers in Turkey. Enrollment will be conducted prospectively across multiple centers following ethics committee approval at each site.
Who may be able to join
- Age ≥18 years
- ICU admission with expected stay ≥24 hours
- Waist circumference and height measurable within 24 hours of admission
Who cannot join
- Age <18 years
- ICU stay <24 hours
- Missing or unmeasurable anthropometric data (e.g., severe edema, abdominal wound, morbid obesity precluding measurement)
- Pregnancy
- Readmission (only first ICU admission included)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Ondokuz Mayis University, School of Medicine
Samsun, Atakum, 55002
Melda İşevi, MD, +905444202552, drmeldaisevi@gmail.com
About this study
Official title: Body Roundness Index as a Predictor of Mortality in Adult Intensive Care Unit Patients: A Prospective Multicenter Cohort Study (BRI-ICU)
This study investigates whether Body Roundness Index (BRI), an anthropometric measure derived from waist circumference and height, can predict mortality in adult intensive care unit (ICU) patients. BRI captures central adiposity and body fat distribution more accurately than Body Mass Index (BMI). In this prospective multicenter cohort study, BRI will be measured at ICU admission and its association with ICU mortality, 28-day mortality, hospital mortality, mechanical ventilation duration, ICU length of stay, and acute kidney injury will be evaluated. The predictive performance of BRI will also be compared with BMI.
Read the detailed description
Body Roundness Index (BRI) is calculated using waist circumference and height, and reflects central adiposity more precisely than BMI. Despite growing evidence supporting BRI as a cardiovascular and metabolic risk predictor in general populations, its prognostic value in critically ill patients remains unexplored.
In this prospective multicenter cohort study, adult patients admitted to participating ICUs will be enrolled. Waist circumference will be measured using a standardized protocol (supine position, iliac crest landmark, end-expiration, inelastic tape, 0.1 cm precision) within 24 hours of ICU admission. BRI will be calculated using the formula: 364.2 - 365.5 × √(1 - ((WC/2π)² / (0.5×height)²)).
The primary outcome is ICU mortality. Secondary outcomes include 28-day mortality, hospital mortality, mechanical ventilation duration, ICU length of stay, and new acute kidney injury (KDIGO stage ≥2). The shape of the BRI-mortality relationship will be assessed using restricted cubic splines. BRI and BMI will be compared head-to-head for discriminative performance. Subgroup analyses will include sepsis patients to evaluate whether BRI resolves the obesity paradox observed with BMI.
- Conditions
- Critical Illness, Obesity & Overweight, Mortality in Intensive Care Units, Body Composition
- Keywords
- Body Roundness Index, BRI, ICU mortality, Critical illness, Anthropometric measures, Central adiposity, BMI, Obesity paradox, Waist circumference
- Medical subject headings
- Critical Illness, Obesity, Overweight, Obesity, Abdominal
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 |
|---|---|---|
| Adult ICU Patients | Adult patients (≥18 years) admitted to the intensive care unit with an expected stay of ≥24 hours. Waist circumference and height are measured within 24 hours of admission to calculate Body Roundness Index (BRI) and BMI. Patients are followed for ICU mortality, 28-day mortality, hospital mortality, mechanical ventilation duration, ICU length of stay, and acute kidney injury (KDIGO stage ≥2). No intervention is applied; this is a prospective observational cohort. |
What is being measured
The primary outcome is the main question the study is designed to answer.
ICU Mortality
Death occurring during ICU stay, assessed from admission to ICU discharge or death, whichever comes first.
Measured: From ICU admission to ICU discharge or death, up to 28 days.
Secondary outcomes (5)
28-Day Mortality
All-cause mortality within 28 days of ICU admission.
Measured: 28 days from ICU admission.
Hospital Mortality
Death occurring during hospital stay
Measured: From ICU admission to hospital discharge or death, up to 90 days.
Mechanical Ventilation Duration
Total days of invasive mechanical ventilation during ICU stay.
Measured: From ICU admission to ICU discharge, up to 28 days.
ICU Length of Stay
Total number of days spent in the ICU
Measured: From ICU admission to ICU discharge, up to 28 days.
Number of Participants with New Acute Kidney Injury (KDIGO Stage ≥2)
New AKI development defined as KDIGO stage ≥2 during ICU stay.
Measured: From ICU admission to ICU discharge, up to 28 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2026
- Study start1 Aug 2026 (estimated)
- Primary completion1 Aug 2027 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critical IllnessStudies of the same condition, open and under way.
- More trials run by Ondokuz Mayıs UniversityThe 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
- Prospective
- Enrolment
- 550 participants (estimated)
- Target duration
- 28 Days
Sponsor and investigators
- Lead sponsor
- Ondokuz Mayıs University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ozkul Yilmaz Colak, Ondokuz Mayıs University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07631429
- Sponsor's protocol ID
- ICU-BRI-001
- Acronym
- BRI-ICU
- Status last verified
- Jun 2026
- First submitted
- 1 Jun 2026
- Last updated
- 8 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data underlying published results will be made available upon reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Body Roundness Index as a Predictor of Mortality in Adult Intensive Care Unit Patients: A Prospective Multicenter Cohort Study (BRI-ICU)
- ClinicalTrials.gov ID
- NCT07631429
- Acronym / sponsor ID
- BRI-ICU / ICU-BRI-001
- Conditions
- Critical Illness, Obesity & Overweight, Mortality in Intensive Care Units, Body Composition
- Keywords
- Body Roundness Index, BRI, ICU mortality, Critical illness, Anthropometric measures, Central adiposity, BMI, Obesity paradox
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 550 participants (estimated)
- Lead sponsor
- Ondokuz Mayıs UniversityUniversity, hospital or other
- Study start
- 1 Aug 2026 (estimated)
- Primary completion
- 1 Aug 2027 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 8 Jun 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 study investigates whether Body Roundness Index (BRI), an anthropometric measure derived from waist circumference and height, can predict mortality in adult intensive care unit (ICU) patients. BRI captures central adiposity and body fat distribution more accurately than Body Mass Index (BMI). In this prospective multicenter cohort study, BRI will be measured at ICU admission and its association with ICU mortality, 28-day mortality, hospital mortality, mechanical ventilation duration, ICU length of stay, and acute kidney injury will be evaluated. The predictive performance of BRI will also be compared with BMI.
Detailed description
Body Roundness Index (BRI) is calculated using waist circumference and height, and reflects central adiposity more precisely than BMI. Despite growing evidence supporting BRI as a cardiovascular and metabolic risk predictor in general populations, its prognostic value in critically ill patients remains unexplored.
In this prospective multicenter cohort study, adult patients admitted to participating ICUs will be enrolled. Waist circumference will be measured using a standardized protocol (supine position, iliac crest landmark, end-expiration, inelastic tape, 0.1 cm precision) within 24 hours of ICU admission. BRI will be calculated using the formula: 364.2 - 365.5 × √(1 - ((WC/2π)² / (0.5×height)²)).
The primary outcome is ICU mortality. Secondary outcomes include 28-day mortality, hospital mortality, mechanical ventilation duration, ICU length of stay, and new acute kidney injury (KDIGO stage ≥2). The shape of the BRI-mortality relationship will be assessed using restricted cubic splines. BRI and BMI will be compared head-to-head for discriminative performance. Subgroup analyses will include sepsis patients to evaluate whether BRI resolves the obesity paradox observed with BMI.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 28 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adult ICU Patients | – | –Adult patients (≥18 years) admitted to the intensive care unit with an expected stay of ≥24 hours. Waist circumference and height are measured within 24 hours of admission to calculate Body Roundness Index (BRI) and BMI. Patients are followed for ICU mortality, 28-day mortality, hospital mortality, mechanical ventilation duration, ICU length of stay, and acute kidney injury (KDIGO stage ≥2). No intervention is applied; this is a prospective observational cohort. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients admitted to the intensive care units of participating tertiary care centers in Turkey. Enrollment will be conducted prospectively across multiple centers following ethics committee approval at each site.
Key inclusion criteria (3 listed)
- Age ≥18 years
- ICU admission with expected stay ≥24 hours
- Waist circumference and height measurable within 24 hours of admission
Key exclusion criteria (5 listed)
- Age <18 years
- ICU stay <24 hours
- Missing or unmeasurable anthropometric data (e.g., severe edema, abdominal wound, morbid obesity precluding measurement)
- Pregnancy
- Readmission (only first ICU admission included)
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
ICU Mortality
Time frame: From ICU admission to ICU discharge or death, up to 28 days.
Death occurring during ICU stay, assessed from admission to ICU discharge or death, whichever comes first.
5 secondary outcomes
28-Day Mortality
Time frame: 28 days from ICU admission.
Hospital Mortality
Time frame: From ICU admission to hospital discharge or death, up to 90 days.
Mechanical Ventilation Duration
Time frame: From ICU admission to ICU discharge, up to 28 days.
ICU Length of Stay
Time frame: From ICU admission to ICU discharge, up to 28 days.
Number of Participants with New Acute Kidney Injury (KDIGO Stage ≥2)
Time frame: From ICU admission to ICU discharge, up to 28 days.
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 8 Jun 2026.
- Individual participant dataSharing planned: Yes. De-identified individual participant data underlying published results will be made available upon reasonable request.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Critical Illness and Obesity & Overweight, run by Ondokuz Mayıs University at 1 site in Turkey (Türkiye).
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 3 inclusion and 5 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 8 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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 Özkul Yilmaz Çolak, MD (+905063349266, ozkulcolak@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ICU Mortality (time frame: From ICU admission to ICU discharge or death, up to 28 days.). 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 8 Jun 2026.