Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07631429

Body Roundness Index and Mortality in ICU Patients

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Ondokuz Mayis University, School of Medicine

Samsun, Atakum, 55002, Turkey (Türkiye)

Location contact

Melda İşevi, MD

CONTACT

[email protected]

+905444202552

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age ≥18 years
  • ICU admission with expected stay ≥24 hours
  • Waist circumference and height measurable within 24 hours of admission

Exclusion criteria

  • 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)

Treatment and study plan

Primary outcomes

  1. 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.

Secondary outcomes

  1. 28-Day Mortality

    Time frame: 28 days from ICU admission.

    All-cause mortality within 28 days of ICU admission.

  2. Hospital Mortality

    Time frame: From ICU admission to hospital discharge or death, up to 90 days.

    Death occurring during hospital stay

  3. Mechanical Ventilation Duration

    Time frame: From ICU admission to ICU discharge, up to 28 days.

    Total days of invasive mechanical ventilation during ICU stay.

  4. ICU Length of Stay

    Time frame: From ICU admission to ICU discharge, up to 28 days.

    Total number of days spent in the ICU

  5. Number of Participants with New Acute Kidney Injury (KDIGO Stage ≥2)

    Time frame: From ICU admission to ICU discharge, up to 28 days.

    New AKI development defined as KDIGO stage ≥2 during ICU stay.

Study contacts

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

Özkul Yilmaz Çolak, MD

CONTACT

[email protected]

+905063349266

Sponsors and collaborators

Lead sponsor

Ondokuz Mayıs University

Other

Registry information

Official study title

Body Roundness Index as a Predictor of Mortality in Adult Intensive Care Unit Patients: A Prospective Multicenter Cohort Study (BRI-ICU)

Acronym: BRI-ICU

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Jun 8, 2026
Registry last updated
Jun 8, 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.

Published trials that share one or more normalized conditions with this study.