Prevalence, Severity, Risk Factors, and Prognostic Value of Hyponatremia in Patients With Traumatic Brain Injury (WATERWAR)
Prevalence, Severity, Risk Factors, and Prognostic Value of Hyponatremia in Patients With Traumatic Brain Injury : a Retrospective Cohort Study.
Hyponatremia (HN) is the most common electrolytic disorder in the traumatic brain injury (TBI) population, found in 17 to 51% of patients according to the series. Two etiologies predominate in the literature, the Syndrome of Inappropriate Anti Diuretic Hormone (SIADH) and the Cerebral Salt Waste Syndrome (CSW), but none has been precisely described in terms of epidemiology, risk factors or severity. Moreover, SIADH and CSH were often confused in previous works.
The main goal of our study is to assess retrospectively prevalence, severity, time to onset, length, risk factors of HN in a large population of TBI patients, as well as treatment modalities and prognosis. A specific distinction was performed between SIADH or CSW.
調査の概要
状態
条件
詳細な説明
This is a retrospective descriptive study.
The included patients will be those admitted in the trauma intensive care unit of Lapeyronie University Hospital (Montpellier, France) with a TBI (head AIS ≥1) during a period of 4 years, 01/01/2014 to 31/12/2017.
Using our databank the investigators estimate 650 to 700 patients who met inclusion criteria during this period and will be analyzed. Inclusions will be confirmed after the opening of medical records.
Definition of SIADH is defined as the occurrence of a hyponatremia (≤135 mmol/L) associated with inappropriate urine concentration (urinary/plasmatic osmolarity ≥1) and a low daily urine volume (<1500 ml/24H).
Definition of CSW is defined as the occurrence of a hyponatremia (≤135 mmol/L) associated with a massive natriuresis (>140 mmol/L) and a daily urine volume > 1500 ml/24H.
Data collection will concern the medical records: medical history, traumatism severity, cerebral injuries on computed tomography, severe complications, specific treatments, and biological course from ICU admission to discharge.
The main endpoint will be the prevalence of hyponatremia (≤135 mmol/L) in the first 10 days after the traumatic brain injury.
The secondary endpoints will be the prevalence specific prevalence of CSW and SIADH, risk factors of these nosological entities, their severity, their timing to onset and their morbimorality.
研究の種類
入学 (予想される)
連絡先と場所
研究連絡先
- 名前：Jonathan CHARBIT, MD
- 電話番号：33 467338256
- メール：j-charbit@chu-montpellier.fr
研究場所
-
-
Montepllier
-
Montpellier、Montepllier、フランス、34295
- 募集
- Uhmontpellier
-
コンタクト：
- Jonathan CHARBIT, MD
- 電話番号：33 467338256
- メール：j-charbit@chu-montpellier.fr
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
説明
Inclusion criteria:
- âge ≥ 18 years
- presence of traumatic brain injury at the ICU admission
Exclusion criteria:
- Discharged from ICU or death < 48 hours from the admission
- Lack of data
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
- 観測モデル：コホート
- 時間の展望：回顧
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 |
|---|---|---|
|
Occurrence of hyponatremia
時間枠：during the 10 first days after the traumatic brain injury
|
Hyponatremia ≤ 135mmol/L
|
during the 10 first days after the traumatic brain injury
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Occurrence SIADH
時間枠：during the 10 first days after the traumatic brain injury
|
Hyponatremia ≤ 135mmol/L associated with inappropriate urine concentration (urinary/plasmatic osmolarity ≥1) and a low daily urine volume (<1500 ml/24H).
|
during the 10 first days after the traumatic brain injury
|
|
Occurrence CSW
時間枠：during the 10 first days after the traumatic brain injury
|
Hyponatremia (≤135 mmol/L) associated with a massive natriuresis (>140 mmol/L) and a daily urine volume > 1500 ml/24H
|
during the 10 first days after the traumatic brain injury
|
|
Determination of risk factors of hyponatremia
時間枠：during the 10 first days after the traumatic brain injury
|
Traumatics injuries, early management, early complications, sodium and water intakes, treatments.
|
during the 10 first days after the traumatic brain injury
|
|
Morbi-mortality
時間枠：Day 1 (Hospitalization)
|
Death, duration of mechanical ventilation, duration of renal replacement therapy, length of ICU stay and length of hospitalization.
|
Day 1 (Hospitalization)
|
協力者と研究者
捜査官
- 主任研究者：Jonathan CHARBIT, MD、University Hospital, Montpellier
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (予想される)
研究の完了 (予想される)
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
キーワード
その他の研究ID番号
- RECHMPL22_0011
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
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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