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)
調査の概要
状態
条件
詳細な説明
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.
研究の種類
入学 (推定)
連絡先と場所
研究連絡先
- 名前：Özkul Yilmaz Çolak, MD
- 電話番号：+905063349266
- メール：ozkulcolak@gmail.com
研究場所
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Atakum
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Samsun、Atakum、トルコ（Türkiye）、55002
- Ondokuz Mayis University, School of Medicine
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コンタクト：
- Melda ISEVI, MD
- 電話番号：+905444202552
- メール：drmeldaisevi@gmail.com
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参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
サンプリング方法
調査対象母集団
説明
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)
研究計画
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
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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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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ICU Mortality
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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28-Day Mortality
時間枠：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
時間枠：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
時間枠：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
時間枠：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)
時間枠：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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協力者と研究者
スポンサー
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- ICU-BRI-001
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
IPD 共有時間枠
IPD 共有アクセス基準
IPD 共有サポート情報タイプ
- STUDY_PROTOCOL
- SAP
- ICF
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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