CO PoisoningALCOPOPNCT05193812
Predicitve Value of Copeptin In CO-intoxicated Patients - A Prospective Cohort Study
An observational study of CO Poisoning, run by Heinrich-Heine University, Duesseldorf.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- CO Poisoning
- How many people
- 120 participants
- Where
- No sites listed yet
- Study dates
- Apr 2022to May 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- adult patients with acute CO-poisoning, defined as CO-Hb levels >10%
Who cannot join
- Unwilling or unable to provide consent
- Inability to follow the procedures of the study, e.g. due to language barriers, psychiatric disorders, dementia
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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
Read the 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).
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.
- Conditions
- CO Poisoning
- Keywords
- carbon monoxide, intoxication, disability-free survival
- Medical subject headings
- Carbon Monoxide Poisoning
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 90 days
Secondary outcomes (9)
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.
Measured: 30 days
WHODAS 2.0 Score at 30 and 90 days after CO-intoxication
12-item WHODAS 2.0 score
Measured: 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
Measured: 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
Measured: 30 and 90 days
All-cause mortality at 30 days and 90 days
mortality after CO-intoxication independent of its cause
Measured: 30 and 90 days
Length of hospital stay
amount of days spent at hospital
Measured: 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
Measured: 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
Measured: 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
Measured: 30 days and 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2022
- Study startApr 2022 (estimated)
- Primary completionMay 2024 (estimated)
- Study completionMay 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CO PoisoningStudies of the same condition, open and under way.
- More trials run by Heinrich-Heine University, DuesseldorfThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Heinrich-Heine University, Duesseldorf
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- PD Stephan Sixt, Principal investigator, Department of Anaesthesiology, University Hospital Duesseldorf
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05193812
- Sponsor's protocol ID
- 2021-1726
- Acronym
- ALCOPOP
- Status last verified
- Mar 2022
- First submitted
- 26 Nov 2021
- Last updated
- 22 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predicitve Value of Copeptin In CO-intoxicated Patients
- ClinicalTrials.gov ID
- NCT05193812
- Acronym / sponsor ID
- ALCOPOP / 2021-1726
- Conditions
- CO Poisoning
- Keywords
- carbon monoxide, intoxication, disability-free survival
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Heinrich-Heine University, DuesseldorfUniversity, hospital or other
- Study start
- Apr 2022 (estimated)
- Primary completion
- May 2024 (estimated)
- Study completion
- May 2024 (estimated)
- First posted
- 18 Jan 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- adult patients with acute CO-poisoning, defined as CO-Hb levels >10%
Key exclusion criteria (2 listed)
- Unwilling or unable to provide consent
- Inability to follow the procedures of the study, e.g. due to language barriers, psychiatric disorders, dementia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
9 secondary outcomes
Disability-free survival at 30 days after CO-intoxication
Time frame: 30 days
WHODAS 2.0 Score at 30 and 90 days after CO-intoxication
Time frame: 30 and 90 days
Days alive and out of hospital at 30 days and 90 days after CO-intoxication
Time frame: 30 and 90 days
MACE at 30 days and 90 days
Time frame: 30 and 90 days
All-cause mortality at 30 days and 90 days
Time frame: 30 and 90 days
Length of hospital stay
Time frame: from admission (day informed consent was given) until day of hospital discharge of the respective participant, up to 90 days
Length of ICU-stay
Time frame: 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
Time frame: 30 days and 90 days
Delayed neurological sequelae (DNS) at 30 days and 90 days measured by a questionnaire
Time frame: 30 days and 90 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
PD Stephan Sixt principal investigator
Department of Anaesthesiology, University Hospital Duesseldorf
Questions about this trial
What is this clinical trial studying?
An observational study of CO Poisoning, run by Heinrich-Heine University, Duesseldorf.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dr. Alexandra Stroda (+49 211 8118102, alexandra.stroda@med.uni-duesseldorf.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
disability-free survival (time frame: 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2022.