- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT07631429
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)
Studieöversikt
Status
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Beräknad)
Kontakter och platser
Studiekontakt
- Namn: Özkul Yilmaz Çolak, MD
- Telefonnummer: +905063349266
- E-post: ozkulcolak@gmail.com
Studieorter
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Atakum
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Samsun, Atakum, Turkiet (Türkiye), 55002
- Ondokuz Mayis University, School of Medicine
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Kontakt:
- Melda ISEVI, MD
- Telefonnummer: +905444202552
- E-post: drmeldaisevi@gmail.com
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Testmetod
Studera befolkning
Beskrivning
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
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / 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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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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ICU Mortality
Tidsram: 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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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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28-Day Mortality
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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)
Tidsram: 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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Samarbetspartners och utredare
Sponsor
Studieavstämningsdatum
Studera stora datum
Studiestart (Beräknad)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- ICU-BRI-001
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
IPD-planbeskrivning
Tidsram för IPD-delning
Kriterier för IPD Sharing Access
IPD-delning som stöder informationstyp
- STUDY_PROTOCOL
- SAV
- ICF
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