Hantavirus Nephropathy in North-Eastern France : Severity Risk Factors and Prognostic Tools (HANTA-NE)
Hantaviruses are emerging pathogens responsible for hemorrhagic fever with renal syndrome. Severity risks factors aren't consensual in litterature, mostly related to scandinavian cohorts. A prognostic score was created to help patient's orientation in healthcare system but wasn't independantly validated (Hentzien, Emerging infectious diseases 2018).
This retrospective cohort of hantavirus infected hospitalized adults patients in the north-eastern quarter of France between 2013 and 2022 will specify the kidney damage during infection and risk factors for a severe form (defined par acute kidney injury KDIGO 3). The previous prognostic score performance will be evaluated in this cohort.
調査の概要
研究の種類
入学 (予想される)
連絡先と場所
研究場所
-
-
-
Nancy、フランス、54000
- Central Hospital
-
-
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:
- hantavirus proven by serology infection
- age above 18 years
- Hospitalisation
Exclusion Criteria:
- age under 18 years
- fulfill opposition form
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
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
|
HANTA-NE
All adult patient hospitalized for hantavirus infection between 01/01/2013 and 31/12/2022 in North Eastern France
|
Observational cohort study
|
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 |
|---|---|---|
|
Creatinin level
時間枠：Through study completion, an average of 2 years
|
Acute Kidney injury KDIGO 3
|
Through study completion, an average of 2 years
|
|
Hemorrhagic syndrome
時間枠：Through study completion, an average of 2 years
|
Major bleeding requiring blood transfusion
|
Through study completion, an average of 2 years
|
|
Death
時間枠：Through study completion, an average of 2 years
|
Death
|
Through study completion, an average of 2 years
|
|
Hospitalisation in intensive care unit
時間枠：Through study completion, an average of 2 years
|
Hospitalisation in intensive care unit
|
Through study completion, an average of 2 years
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Score performance to predict severity
時間枠：Through study completion, an average of 2 years
|
Correlation between severity predicted by the score and bio-clinical severity during hospitalization. Score composition : Hematuria = 7 Visual disorders = 8 Leucocyte count > 10 x 10^9 cells/L = 9 Nephrotoxic drug exposure (NSAID, iodinated contrast media, diuretics, renin angiotensin aldosterone system inhibitors, aminoglycosides, glycopeptides) = 10 Thrombocytopenia < or = 90 000/mm3 = 11 Risk group according score scale 0-10 Low risk 11-19 intermediate risk 20-45 high risk |
Through study completion, an average of 2 years
|
|
Hypotension
時間枠：Through study completion, an average of 2 years
|
Lowest systolic blood presure during hospitalisation < 90mmHg
|
Through study completion, an average of 2 years
|
|
Proteinuria
時間枠：Through study completion,an average of 2 years
|
Proteinuria during hospitalisation defined by proteinuria/creatininuria above 500 mg/g or equivalent
|
Through study completion,an average of 2 years
|
|
Urinary dipstick
時間枠：Through study completion, an average of 2 years
|
Leucocyturia or hematuria
|
Through study completion, an average of 2 years
|
|
ALAT, ASAT
時間枠：Through study completion, an average of 2 years
|
Liver cytolysis
|
Through study completion, an average of 2 years
|
|
calcium
時間枠：Through study completion, an average of 2 years
|
hypocalcemia, hypercalcemia
|
Through study completion, an average of 2 years
|
|
phosphorus
時間枠：Through study completion, an average of 2 years
|
hypophaspahtaemia, hyperphasphatemia
|
Through study completion, an average of 2 years
|
|
potassium
時間枠：Through study completion, an average of 2 years
|
hypokaliemia, hyperkaliemia
|
Through study completion, an average of 2 years
|
|
sodium
時間枠：Through study completion, an average of 2 years
|
blood sodium level disorders
|
Through study completion, an average of 2 years
|
|
bicarbonate blood level
時間枠：Through study completion, an average of 2 years
|
metabolic acidosis, metabolic alcalosis
|
Through study completion, an average of 2 years
|
|
Heamoglobin
時間枠：Through study completion, an average of 2 years
|
Anemia
|
Through study completion, an average of 2 years
|
|
platelets level
時間枠：Through study completion, an average of 2 years
|
thrombocytemia
|
Through study completion, an average of 2 years
|
|
Urine output
時間枠：Through study completion, an average of 2 years
|
Polyruria above 3 L/day
|
Through study completion, an average of 2 years
|
協力者と研究者
捜査官
- 主任研究者：Alice CORBEL, M.D.、Central Hospital, Nancy, France
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
追加の関連 MeSH 用語
その他の研究ID番号
- 2022PI034
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?
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
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
HANTA-NEの臨床試験
-
GlaxoSmithKline引きこもった
-
SEAMEO Regional Centre for Food and NutritionIndonesia University; Ministry of Health Republic of Indonesia; Health Polytechnic of Pontianak; Health Polytechnic of Malang と他の協力者わからない
-
BlueWillow BiologicsNational Institute of Allergy and Infectious Diseases (NIAID); University of Maryland, Baltimore積極的、募集していない
-
University of PennsylvaniaNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)完了
-
University of MemphisNational Institute on Alcohol Abuse and Alcoholism (NIAAA)完了