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Clinical Trials/NCT07631429
NCT07631429Not yet recruitingNot Applicable

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

Ondokuz Mayıs University1 site in 1 country550 target enrollmentStarted: August 1, 2026Last updated:

Trial Snapshot

Phase
Not Applicable
Status
Not yet recruiting
Sponsor
Enrollment
550
Locations
1

Study Overview

Brief 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). 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

Study Type
Observational
Observational Model
Cohort
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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)

Investigators

Sponsor
Ondokuz Mayıs University
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Ozkul Yilmaz Colak

Lecturer, Department of Internal Medicine, Division of Intensive Care, Ondokuz Mayıs University Faculty of Medicine

Ondokuz Mayıs University

Study Sites (1)

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