Body Roundness Index and Mortality in ICU Patients

NCT07631429 | Not Yet Recruiting

• 1 other identifier: ICU-BRI-001
• Study Type: observational
• Target: 550
• Locations: 1 country
• Sites: 1

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.

Conditions

Critical Illness; Obesity & Overweight; Body Composition; Mortality in Intensive Care Units

Keywords

Body Roundness Index; BRI; ICU mortality; Critical illness; Anthropometric measures; Central adiposity; BMI; Obesity paradox; Waist circumference

Outcome Measures

Primary Outcomes (1)

• ICU Mortality

  Death occurring during ICU stay, assessed from admission to ICU discharge or death, whichever comes first.

  From ICU admission to ICU discharge or death, up to 28 days.

Secondary Outcomes (5)

• 28-Day Mortality

  28 days from ICU admission.

• Hospital Mortality

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

• Mechanical Ventilation Duration

  From ICU admission to ICU discharge, up to 28 days.

• ICU Length of Stay

  From ICU admission to ICU discharge, up to 28 days.

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

  From ICU admission to ICU discharge, up to 28 days.

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Ondokuz Mayıs University: lead

Study Sites (1)

Ondokuz Mayis University, School of Medicine

Samsun, Atakum, 55002, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Critical Illness; Obesity; Overweight; Obesity, Abdominal

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms

Central Study Contacts

Özkul Yilmaz Çolak, MD

CONTACT

+905063349266; ozkulcolak@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 28 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer, Department of Internal Medicine, Division of Intensive Care, Ondokuz Mayıs University Faculty of Medicine

Study Record Dates

• First Submitted: June 1, 2026
• First Posted: June 8, 2026
• Study Start (Estimated): August 1, 2026
• Primary Completion (Estimated): August 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: June 8, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Beginning 6 months after primary results publication, available for 2 years.
• Access Criteria: Researchers who provide a methodologically sound proposal. Requests should be directed to the corresponding author. Data will be shared after signing a data access agreement.

Locations

TU (1)