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Predicitve Value of Copeptin In CO-intoxicated Patients - A Prospective Cohort Study (ALCOPOP)

2022年3月21日 更新者:Heinrich-Heine University, Duesseldorf

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

研究概览

地位

尚未招聘

条件

详细说明

Aims of the study

To evaluate early Copeptin at arrival at emergency department based on the following:

  1. 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).
  2. 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:

  1. 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).
  2. 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.

研究类型

观察性的

注册 (预期的)

120

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

取样方法

概率样本

研究人群

The University Hospital Duesseldorf is one of three centres for hyperbaric oxygen therapy (HBO) in western Germany treating about 60-100 patients with CO-intoxication annually. we will screen each patient with CO-intoxication admitted to the emergency department of the Univerisity Hospital Duesseldorf.

描述

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

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
disability-free survival
大体时间: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

次要结果测量

结果测量
措施说明
大体时间
Disability-free survival at 30 days after CO-intoxication
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间:30 and 90 days
mortality after CO-intoxication independent of its cause
30 and 90 days
Length of hospital stay
大体时间: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
大体时间: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
大体时间: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
大体时间: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

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:PD Stephan Sixt、Department of Anaesthesiology, University Hospital Duesseldorf

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (预期的)

2022年4月1日

初级完成 (预期的)

2024年5月1日

研究完成 (预期的)

2024年5月1日

研究注册日期

首次提交

2021年11月26日

首先提交符合 QC 标准的

2022年1月14日

首次发布 (实际的)

2022年1月18日

研究记录更新

最后更新发布 (实际的)

2022年3月22日

上次提交的符合 QC 标准的更新

2022年3月21日

最后验证

2022年3月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • 2021-1726

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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