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

21. marts 2022 opdateret af: 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

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Detaljeret beskrivelse

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.

Undersøgelsestype

Observationel

Tilmelding (Forventet)

120

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Sandsynlighedsprøve

Studiebefolkning

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.

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
disability-free survival
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Disability-free survival at 30 days after CO-intoxication
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 30 and 90 days
mortality after CO-intoxication independent of its cause
30 and 90 days
Length of hospital stay
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Efterforskere

  • Ledende efterforsker: PD Stephan Sixt, Department of Anaesthesiology, University Hospital Duesseldorf

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Forventet)

1. april 2022

Primær færdiggørelse (Forventet)

1. maj 2024

Studieafslutning (Forventet)

1. maj 2024

Datoer for studieregistrering

Først indsendt

26. november 2021

Først indsendt, der opfyldte QC-kriterier

14. januar 2022

Først opslået (Faktiske)

18. januar 2022

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

22. marts 2022

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

21. marts 2022

Sidst verificeret

1. marts 2022

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 2021-1726

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Kliniske forsøg med CO Poisoning

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