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Resuscitation Outcomes in the Netherlands (ROUTiNE)

14 de julho de 2019 atualizado por: 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.

Visão geral do estudo

Status

Concluído

Condições

Descrição detalhada

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.

Tipo de estudo

Observacional

Inscrição (Real)

700

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

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

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

18 anos e mais velhos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Sim

Gêneros Elegíveis para o Estudo

Tudo

Método de amostragem

Amostra Não Probabilística

População do estudo

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.

Descrição

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.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
one-year survival
Prazo: one year
Survival one year after in-hospital cardiac arrest
one year

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
SF-12
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Erasmus Medical Center

Investigadores

  • Investigador principal: Robert Jan Stolker, MD PhD, Erasmus Medical Center
  • Investigador principal: Marc Schluep, MD, Erasmus Medical Center
  • Cadeira de estudo: Sanne Hoeks, PhD, Erasmus Medical Center
  • Cadeira de estudo: Henrik Endeman, MD PhD, OLVG

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

1 de janeiro de 2017

Conclusão Primária (Real)

1 de junho de 2019

Conclusão do estudo (Real)

1 de julho de 2019

Datas de inscrição no estudo

Enviado pela primeira vez

6 de abril de 2017

Enviado pela primeira vez que atendeu aos critérios de CQ

18 de abril de 2017

Primeira postagem (Real)

19 de abril de 2017

Atualizações de registro de estudo

Última Atualização Postada (Real)

16 de julho de 2019

Última atualização enviada que atendeu aos critérios de controle de qualidade

14 de julho de 2019

Última verificação

1 de julho de 2019

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

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

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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