Body Roundness Index and Mortality in ICU Patients (BRI-ICU)
Body Roundness Index as a Predictor of Mortality in Adult Intensive Care Unit Patients: A Prospective Multicenter Cohort Study (BRI-ICU)
Studieoversikt
Status
Detaljert 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.
Studietype
Registrering (Antatt)
Kontakter og plasseringer
Studiekontakt
- Navn: Özkul Yilmaz Çolak, MD
- Telefonnummer: +905063349266
- E-post: ozkulcolak@gmail.com
Studiesteder
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Atakum
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Samsun, Atakum, Tyrkia (Türkiye), 55002
- Ondokuz Mayis University, School of Medicine
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Ta kontakt med:
- Melda ISEVI, MD
- Telefonnummer: +905444202552
- E-post: drmeldaisevi@gmail.com
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Prøvetakingsmetode
Studiepopulasjon
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
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
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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.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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ICU Mortality
Tidsramme: From ICU admission to ICU discharge or death, up to 28 days.
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Death occurring during ICU stay, assessed from admission to ICU discharge or death, whichever comes first.
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From ICU admission to ICU discharge or death, up to 28 days.
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
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28-Day Mortality
Tidsramme: 28 days from ICU admission.
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All-cause mortality within 28 days of ICU admission.
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28 days from ICU admission.
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Hospital Mortality
Tidsramme: From ICU admission to hospital discharge or death, up to 90 days.
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Death occurring during hospital stay
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From ICU admission to hospital discharge or death, up to 90 days.
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Mechanical Ventilation Duration
Tidsramme: From ICU admission to ICU discharge, up to 28 days.
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Total days of invasive mechanical ventilation during ICU stay.
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From ICU admission to ICU discharge, up to 28 days.
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ICU Length of Stay
Tidsramme: From ICU admission to ICU discharge, up to 28 days.
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Total number of days spent in the ICU
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From ICU admission to ICU discharge, up to 28 days.
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Number of Participants with New Acute Kidney Injury (KDIGO Stage ≥2)
Tidsramme: From ICU admission to ICU discharge, up to 28 days.
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New AKI development defined as KDIGO stage ≥2 during ICU stay.
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From ICU admission to ICU discharge, up to 28 days.
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Samarbeidspartnere og etterforskere
Sponsor
Studierekorddatoer
Studer hoveddatoer
Studiestart (Antatt)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- ICU-BRI-001
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
IPD-planbeskrivelse
IPD-delingstidsramme
Tilgangskriterier for IPD-deling
IPD-deling Støtteinformasjonstype
- STUDY_PROTOCOL
- SEVJE
- ICF
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