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

Study Overview

• Status: Not yet recruiting
• Conditions: CO Poisoning

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.

• Study Type: Observational
• Enrollment (Anticipated): 120

Contacts and Locations

• Study Contact: Name: Dr. Alexandra Stroda; Phone Number: +49 211 8118102; Email: alexandra.stroda@med.uni-duesseldorf.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
disability-free survival	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Disability-free survival at 30 days after CO-intoxication	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	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	patient centred outcome; amount of days spent at home after CO-intoxication	30 and 90 days
MACE at 30 days 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	mortality after CO-intoxication independent of its cause	30 and 90 days
Length of hospital stay	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	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	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	Symptoms and signs as mentioned above (see outcome 9) occurring between hospital discharge and follow-up	30 days and 90 days

Collaborators and Investigators

• Sponsor: Heinrich-Heine University, Duesseldorf
• Investigators: Principal Investigator: PD Stephan Sixt, Department of Anaesthesiology, University Hospital Duesseldorf

Study record dates

Study Major Dates

• Study Start (Anticipated): April 1, 2022
• Primary Completion (Anticipated): May 1, 2024
• Study Completion (Anticipated): May 1, 2024

Study Registration Dates

• First Submitted: November 26, 2021
• First Submitted That Met QC Criteria: January 14, 2022
• First Posted (Actual): January 18, 2022

Study Record Updates

• Last Update Posted (Actual): March 22, 2022
• Last Update Submitted That Met QC Criteria: March 21, 2022
• Last Verified: March 1, 2022

More Information

Terms related to this study

• Keywords: intoxication; carbon monoxide; disability-free survival
• Additional Relevant MeSH Terms: Chemically-Induced Disorders; Poisoning
• Other Study ID Numbers: 2021-1726

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No