Diese Seite wurde automatisch übersetzt und die Genauigkeit der Übersetzung wird nicht garantiert. Bitte wende dich an die englische Version für einen Quelltext.

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

21. März 2022 aktualisiert von: 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

Studienübersicht

Status

Noch keine Rekrutierung

Bedingungen

Detaillierte Beschreibung

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.

Studientyp

Beobachtungs

Einschreibung (Voraussichtlich)

120

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre und älter (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Probenahmeverfahren

Wahrscheinlichkeitsstichprobe

Studienpopulation

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.

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
disability-free survival
Zeitfenster: 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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Disability-free survival at 30 days after CO-intoxication
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 30 and 90 days
mortality after CO-intoxication independent of its cause
30 and 90 days
Length of hospital stay
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Ermittler

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

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Voraussichtlich)

1. April 2022

Primärer Abschluss (Voraussichtlich)

1. Mai 2024

Studienabschluss (Voraussichtlich)

1. Mai 2024

Studienanmeldedaten

Zuerst eingereicht

26. November 2021

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

14. Januar 2022

Zuerst gepostet (Tatsächlich)

18. Januar 2022

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

22. März 2022

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

21. März 2022

Zuletzt verifiziert

1. März 2022

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • 2021-1726

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

Klinische Studien zur CO Poisoning

Abonnieren