Predicitve Value of Copeptin In CO-intoxicated Patients
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 120
- Primary Endpoint
- disability-free survival
Study Overview
Brief Summary
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
Detailed Description
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).
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
disability-free survival
Time Frame: 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.
Secondary Outcomes
- MACE at 30 days and 90 days(30 and 90 days)
- Length of ICU-stay(from admission (day informed consent was given) until day of hospital discharge of the respective participant, up to 90 days)
- Days alive and out of hospital at 30 days and 90 days after CO-intoxication(30 and 90 days)
- Disability-free survival at 30 days after CO-intoxication(30 days)
- WHODAS 2.0 Score at 30 and 90 days after CO-intoxication(30 and 90 days)
- All-cause mortality at 30 days and 90 days(30 and 90 days)
- Length of hospital stay(from admission (day informed consent was given) until day of hospital discharge of the respective participant, up to 90 days)
- Delayed neurological sequelae (DNS) at 30 days and 90 days measured by a questionnaire(30 days and 90 days)
- Persistent neurological sequelae (PNS) at 30 days and 90 days measured by a questionnaire(30 days and 90 days)