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Body Roundness Index and Mortality in ICU Patients (BRI-ICU)

5. juni 2026 opdateret af: Ozkul Yilmaz Colak, Ondokuz Mayıs University

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.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Detaljeret beskrivelse

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.

Undersøgelsestype

Observationel

Tilmelding (Anslået)

550

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Tyrkiet (Türkiye)
    • Atakum
      • Samsun, Atakum, Tyrkiet (Türkiye), 55002
        • Ondokuz Mayis University, School of Medicine
        • Kontakt:

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

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.

Beskrivelse

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)

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
ICU Mortality
Tidsramme: 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.
From ICU admission to ICU discharge or death, up to 28 days.

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
28-Day Mortality
Tidsramme: 28 days from ICU admission.
All-cause mortality within 28 days of ICU admission.
28 days from ICU admission.
Hospital Mortality
Tidsramme: From ICU admission to hospital discharge or death, up to 90 days.
Death occurring during hospital stay
From ICU admission to hospital discharge or death, up to 90 days.
Mechanical Ventilation Duration
Tidsramme: From ICU admission to ICU discharge, up to 28 days.
Total days of invasive mechanical ventilation during ICU stay.
From ICU admission to ICU discharge, up to 28 days.
ICU Length of Stay
Tidsramme: From ICU admission to ICU discharge, up to 28 days.
Total number of days spent in the ICU
From ICU admission to ICU discharge, up to 28 days.
Number of Participants with New Acute Kidney Injury (KDIGO Stage ≥2)
Tidsramme: From ICU admission to ICU discharge, up to 28 days.
New AKI development defined as KDIGO stage ≥2 during ICU stay.
From ICU admission to ICU discharge, up to 28 days.

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Ondokuz Mayıs University

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. august 2026

Primær færdiggørelse (Anslået)

1. august 2027

Studieafslutning (Anslået)

1. december 2027

Datoer for studieregistrering

Først indsendt

1. juni 2026

Først indsendt, der opfyldte QC-kriterier

5. juni 2026

Først opslået (Faktiske)

8. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

8. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

5. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • ICU-BRI-001

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

De-identified individual participant data underlying published results will be made available upon reasonable request.

IPD-delingstidsramme

Beginning 6 months after primary results publication, available for 2 years.

IPD-delingsadgangskriterier

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.

IPD-deling Understøttende informationstype

  • STUDY_PROTOCOL
  • SAP
  • ICF

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