Clinical trial NCT05193812: Predicitve Value of Copeptin In CO-intoxicated Patients - A Prospective Cohort Study
Official title: Predicitve Value of Copeptin In CO-intoxicated Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: CO Poisoning
Keywords: carbon monoxide
intoxication
disability-free survival
Lead sponsor: Heinrich-Heine University, Duesseldorf
Sponsor class: OTHER
First posted: 2022-01-18
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 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.

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:

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.

Eligibility criteria: 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

Primary outcomes:
measure: disability-free survival
timeFrame: 90 days
Secondary outcomes:
measure: Disability-free survival at 30 days after CO-intoxication
timeFrame: 30 days
measure: WHODAS 2.0 Score at 30 and 90 days after CO-intoxication
timeFrame: 30 and 90 days
measure: Days alive and out of hospital at 30 days and 90 days after CO-intoxication
timeFrame: 30 and 90 days
measure: MACE at 30 days and 90 days
timeFrame: 30 and 90 days
measure: All-cause mortality at 30 days and 90 days
timeFrame: 30 and 90 days
measure: Length of hospital stay
timeFrame: from admission (day informed consent was given) until day of hospital discharge of the respective participant, up to 90 days
measure: Length of ICU-stay
timeFrame: from admission (day informed consent was given) until day of hospital discharge of the respective participant, up to 90 days
measure: Persistent neurological sequelae (PNS) at 30 days and 90 days measured by a questionnaire
timeFrame: 30 days and 90 days
measure: Delayed neurological sequelae (DNS) at 30 days and 90 days measured by a questionnaire
timeFrame: 30 days and 90 days
Other outcomes:
Locations:
Study officials:
affiliation: Department of Anaesthesiology, University Hospital Duesseldorf
name: PD Stephan Sixt
role: PRINCIPAL_INVESTIGATOR
References: