Predicitve Value of Copeptin In CO-intoxicated Patients - A Prospective Cohort Study (ALCOPOP)
Predicitve Value of Copeptin In CO-intoxicated Patients
ALCOPOP is a prospective cohort study entitled "Predicitve Value of Copeptin in CO-intoxicated Patients". The primary objective of this study is to assess the independent association between early Copeptin and / or Troponin concentrations at presentation at the emergency department with disability-free survival after carbon monoxide (CO) -intoxication. Further secondary aims are to determine the independent association between early postoperative Copeptin and / or Troponin concentrations and major adverse cardiovascular events (MACE), mortality and long-term neurological outcome.
Adult patients with acute CO-intoxication (CO-hemoglobin >10%) will be included. Main exposure will be Copeptin and Troponin concentrations. Primary endpoint will be disability-free survival at 90 days. The investigators assume to include 120 patients in 24 months
調査の概要
状態
条件
詳細な説明
Aims of the study
To evaluate early Copeptin at arrival at emergency department based on the following:
- Discrimination for 90-day-disability-free survival (primary), 30-day-disability-free survival (secondary) and for 30-day and 90-day MACE, 30-day and 90-day all-cause mortality (secondary) as well as 30-day and 90-day-neurological outcome (secondary) and length of hospital stay (secondary).
- Independent association with 90-day disability-free survival (primary), days alive out of hospital at 30 days and 90 days (secondary) and MACE at 30 days and 90 days after CO-intoxication, 30-day and 90-day all-cause mortality and (secondary) as well as the 30-day and 90-day neurological outcome (secondary) and length of hospital stay (secondary).
To evaluate early Troponin at arrival at emergency department in terms of:
- Discrimination for 90-day disability-free survival (primary), 30-day-disability-free survival (second) and for 30-day and 90-day MACE as well as 30-day and 90-day all- cause mortality (secondary) and length of hospital stay (secondary).
- Independent association with 90-day-disability-free survival (primary), days alive out of hospital at 30 days and 90 days (secondary) and MACE at 30 days and 90 days after CO-intoxication as well as 30-day and 90 days all-cause mortality (secondary) and length of hospital stay (secondary).
The initial patient visit will take place after screening of patients and eligibility assessment and no later than on the day after admission to the emergency department (day +1). After provision of patient information and written informed consent, baseline data will be extracted from clinical source documents. The investigators plan to sample blood upon arrival in the emergency department (Troponin and Copeptin), and on day 1 and 2 after CO-intoxication (Troponin). Another blood sample will be carried out after hyperbaric oxygen (HBO) therapy to obtain a a second Copeptin measurement. Sampling will occur as far as possible concurrently to clinically indicated blood samples. Blood samples will be analyzed in a certified laboratory.
The investigators will contact all patients after 30 days and 90 days by postal mail and/or phone call (personnel blinded to biomarkers concentrations) to obtain for the 12-item WHO Disability Assessment Schedule (WHODAS) 2.0 and information on potential events. In case of the report of potential endpoints, the patient's general practitioner and/or treating hospital will be contacted for more detailed information and source documents for MACE, persistent neurological sequelae (PNS) and delayed neurological sequela (DNS) adjudication. Adjudicators will be trained in the study definitions and blinded to biomarkers concentrations.
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：Dr. Alexandra Stroda
- 電話番号：+49 211 8118102
- メール：alexandra.stroda@med.uni-duesseldorf.de
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:
- adult patients with acute CO-poisoning, defined as CO-Hb levels >10%
Exclusion Criteria:
- Unwilling or unable to provide consent
- Inability to follow the procedures of the study, e.g. due to language barriers, psychiatric disorders, dementia
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
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 |
|---|---|---|
|
disability-free survival
時間枠：90 days
|
Disability is defined as a persistent impairment in health status, as measured by the 12-item WHO Disability Assessment Schedule (WHODAS) 2.0 score, of at least 24 points when using response scores of 1-5 for each item, reflecting a disability level of at least 25% and being the threshold point between 'disabled' and 'not disabled' as per WHO guideline.
|
90 days
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Disability-free survival at 30 days after CO-intoxication
時間枠：30 days
|
Disability is defined as a persistent (at least 1 month) impairment in health status, as measured by the 12-item WHODAS 2.0 score, of at least 24 points when using response scores of 1-5 for each item, reflecting a disability level of at least 25% and being the threshold point between 'disabled' and 'not disabled' as per WHO guideline.
|
30 days
|
|
WHODAS 2.0 Score at 30 and 90 days after CO-intoxication
時間枠：30 and 90 days
|
12-item WHODAS 2.0 score
|
30 and 90 days
|
|
Days alive and out of hospital at 30 days and 90 days after CO-intoxication
時間枠：30 and 90 days
|
patient centred outcome; amount of days spent at home after CO-intoxication
|
30 and 90 days
|
|
MACE at 30 days and 90 days
時間枠：30 and 90 days
|
defined as non-fatal cardiac arrest, acute myocardial infarction, congestive heart failure or transfer to a higher unit of care, atrial fibrillation or stroke
|
30 and 90 days
|
|
All-cause mortality at 30 days and 90 days
時間枠：30 and 90 days
|
mortality after CO-intoxication independent of its cause
|
30 and 90 days
|
|
Length of hospital stay
時間枠：from admission (day informed consent was given) until day of hospital discharge of the respective participant, up to 90 days
|
amount of days spent at hospital
|
from admission (day informed consent was given) until day of hospital discharge of the respective participant, up to 90 days
|
|
Length of ICU-stay
時間枠：from admission (day informed consent was given) until day of hospital discharge of the respective participant, up to 90 days
|
amount of days spent at ICU
|
from admission (day informed consent was given) until day of hospital discharge of the respective participant, up to 90 days
|
|
Persistent neurological sequelae (PNS) at 30 days and 90 days measured by a questionnaire
時間枠：30 days and 90 days
|
Symptoms or signs attributable to CO poisoning that are evident immediately following poisoning including subtle personality changes, mood disorders headaches, tiredness, difficulty in concentrating, difficulty in sleeping, visual disorders, and new difficulties with social or professional activities and memory impairment to (much less commonly) focal neurological injuries and other severely disabling manifestations of hypoxic brain injury
|
30 days and 90 days
|
|
Delayed neurological sequelae (DNS) at 30 days and 90 days measured by a questionnaire
時間枠：30 days and 90 days
|
Symptoms and signs as mentioned above (see outcome 9) occurring between hospital discharge and follow-up
|
30 days and 90 days
|
協力者と研究者
捜査官
- 主任研究者：PD Stephan Sixt、Department of Anaesthesiology, University Hospital Duesseldorf
研究記録日
主要日程の研究
研究開始 (予想される)
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
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本研究に関する用語
医薬品およびデバイス情報、研究文書
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