Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

Resuscitation Outcomes in the Netherlands (ROUTiNE)

14. juli 2019 opdateret af: Marc Schluep, Erasmus Medical Center

Resuscitation Outcomes in the Netherlands Study

The Resuscitation Outcomes in the Netherlands - study assesses one-year survival and quality of life after In-Hospital Cardiac Arrest(IHCA). It's design is a multicenter prospective observational cohort study which will include all patients undergoing cardiopulmonary resuscitation (CPR) for IHCA in 2017. Current literature describes poor survival after IHCA and no risk stratification tool for long-term outcome is available. Furthermore no such study has ever been performed in the Netherlands. The investigators aim to gain further insight in this major adverse event.

Studieoversigt

Detaljeret beskrivelse

Background: In-hospital cardiac arrest (IHCA) is a serious adverse event for which cardiopulmonary resuscitation (CPR) can be performed to restore circulation. Currently survival after IHCA is poor. To assess the success of resuscitation attempts there is a need for research that focuses on long-term survival and quality of life. Patient selection for CPR, prevention of cardiac arrest and improvement of CPR techniques are crucial for improving qualitative survival. To assess the feasibility of this project a single-center retrospective cohort study was conducted over a 10-year period in the OLVG hospital. For all patients who received CPR survival to discharge was 32% and one-year survival was 22%. This is slightly higher than survival reported in contemporary literature. Due to it's design no prognostic variables could be derived from this study, however data suggested age and Charlson Comorbidity Index could prove useful in predicting long-term outcome. In the consecutive year this study was designed.

Hypothesis: The hypothesis is that one-year survival after IHCA in Dutch hospitals is poor, consistent with international literature and our feasibility trial, and survival can be improved through selection, prevention and training.

Objective: The main objective of this study is to assess the one-year survival of patients after CPR for in-hospital cardiac arrest. The secondary objectives are to assess quality of life and functional status after successful CPR. Furthermore the investigators aim to assess if there are patient-related predicting factors for these outcome measures and to assess whether outcomes are influenced by hospital-related factors (i.e. CPR training and treatment options).

Study design: The current study has a prospective, observational design, with a 12-month follow-up. Patients will be included from January 1st 2017. Patient data collection will take place at four time points: T0= directly post-CPR, T1= at hospital discharge or at in-hospital death, T2= 3 months after CPR, T3= 12 months after CPR. Clinical data will be collected at all time points. Quality of life data will be collected at T2 and T3 by means of validated questionnaires. We will assess functional status through questionnaires and link these to pre-existing and acquired comorbidities (e.g. stroke). General hospital data and data concerning the level of CPR-training will be ascertained at four moments during the first year of patient inclusion.

Study population: An estimated six hundred patients of 18 years or older who will receive CPR for cardiac arrest in the participating hospitals. This will include all cases of in-hospital cardiac arrest, also including Operation Room (OR), Intensive/Coronary Care Unit (ICU/CCU) and Emergency Department (ER). Patients in whom CPR was started before arrival in hospital will be excluded.

Expected results: The main study endpoints are one-year survival and quality of life. Secondary endpoints are direct survival and survival to discharge. The first preliminary results are expected in the first quarter of 2018. After conclusion of this project the investigators of this project aim to develop recommendations that will improve survival after IHCA.

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

700

Kontakter og lokationer

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

Studiesteder

    • Gelderland
      • Arnhem, Gelderland, Holland, 6815AD
        • Rijnstate Ziekenhuis
    • Noord-Holland
      • Amsterdam, Noord-Holland, Holland, 1091AC
        • OLVG
    • Overijssel
      • Deventer, Overijssel, Holland, 7416SE
        • Deventer Ziekenhuis
      • Enschede, Overijssel, Holland, 7512KZ
        • Medisch Spectrum Twente
      • Zwolle, Overijssel, Holland, 8025AB
        • Isala Klinieken
    • Zeeland
      • Terneuzen, Zeeland, Holland, 4535PA
        • Zorgsaam Zeeuws-Vlaanderen
    • Zuid-Holland
      • Breda, Zuid-Holland, Holland, 4818CK
        • Amphia Ziekenhuis
      • Delft, Zuid-Holland, Holland, 2625AD
        • Reinier de Graaf Gasthuis
      • Dordrecht, Zuid-Holland, Holland, 3318AT
        • Albert Schweitzer Ziekenhuis
      • Rotterdam, Zuid-Holland, Holland, 3079DZ
        • Maasstad Ziekenhuis
      • Rotterdam, Zuid-Holland, Holland, 3045PM
        • Sint Franciscus Vlietland Groep
      • The Hague, Zuid-Holland, Holland
        • Haaglanden Medisch Centrum

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

Ja

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

An estimated six hundred patients of 18 years or older who will receive CPR for cardiac arrest in the participating hospitals (n=15). This will include all cases of in-hospital cardiac arrest, also including Operation Room (OR), Intensive/Coronary Care Unit (ICU/CCU) and Emergency Department (ER). Patients in whom CPR was started before arrival in hospital will be excluded.

Beskrivelse

Inclusion Criteria:

  • Patients over 18 years of age
  • Receiving cardiopulmonary resuscitation, as defined by starting manual chest compressions, for a circulatory arrest occuring in-hospital.
  • In hospital is defined as all hospital wards, departments, outpatient clinics, and hallways.

Exclusion Criteria:

  • Children (<18 years of age)
  • Purposely induced cardiac arrest (e.g. cardiac surgery)
  • Purposely induced arrhythmias (e.g. electrophysiological treatment)
  • Refusal to participate
  • Primary out-of-hospital cardiac arrest with re-arrest <24h after hospital admission.

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
one-year survival
Tidsramme: one year
Survival one year after in-hospital cardiac arrest
one year

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
SF-12
Tidsramme: 3 months and one year after in-hospital cardiac arrest
Quality of life measured by SF-12 questionnaire
3 months and one year after in-hospital cardiac arrest
EuroQoL
Tidsramme: 3 months and one year after in-hospital cardiac arrest
Quality of life measured by EuroQoL questionnaire
3 months and one year after in-hospital cardiac arrest
HADS
Tidsramme: 3 months and one year after in-hospital cardiac arrest
Quality of life measured by Hospital Anxiety and Depression Scale questionnaire
3 months and one year after in-hospital cardiac arrest
Charlson Comorbidity Index
Tidsramme: 3 months and one year after in-hospital cardiac arrest
Development of new comorbidities as defined by the Charlson Comorbidity Index.
3 months and one year after in-hospital cardiac arrest
Cardiovascular events
Tidsramme: 3 months and one year after in-hospital cardiac arrest
Development of new cardiovascular events (e.g. myocardial infarction, stroke), by means of checkbox question.
3 months and one year after in-hospital cardiac arrest
Working life
Tidsramme: Prior to in-hospital cardiac arrest and 3 months and one year after in-hospital cardiac arrest
Participation in working life; status before cardiac arrest and after by means of checkbox question.
Prior to in-hospital cardiac arrest and 3 months and one year after in-hospital cardiac arrest
TICS
Tidsramme: 3 months after in-hospital cardiac arrest, if patients are not able to respond to regular questionnaires (paper)
Telephonic interview for Cognitive Status
3 months after in-hospital cardiac arrest, if patients are not able to respond to regular questionnaires (paper)
CSI
Tidsramme: 3 months and one year after in-hospital cardiac arrest
Caregiver strain index for caregivers of In-Hospital Cardiac Arrest Survivors
3 months and one year after in-hospital cardiac arrest

Samarbejdspartnere og efterforskere

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

Efterforskere

  • Ledende efterforsker: Robert Jan Stolker, MD PhD, Erasmus Medical Center
  • Ledende efterforsker: Marc Schluep, MD, Erasmus Medical Center
  • Studiestol: Sanne Hoeks, PhD, Erasmus Medical Center
  • Studiestol: Henrik Endeman, MD PhD, OLVG

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 (Faktiske)

1. januar 2017

Primær færdiggørelse (Faktiske)

1. juni 2019

Studieafslutning (Faktiske)

1. juli 2019

Datoer for studieregistrering

Først indsendt

6. april 2017

Først indsendt, der opfyldte QC-kriterier

18. april 2017

Først opslået (Faktiske)

19. april 2017

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

16. juli 2019

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

14. juli 2019

Sidst verificeret

1. juli 2019

Mere information

Begreber relateret til denne undersøgelse

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • ABR55661.078.16
  • NTR6145 (Anden identifikator: Dutch Trial Registry)
  • MEC-2016-563 (Anden identifikator: Erasmus MC METC)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Livskvalitet

3
Abonner