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Heart ArrestROUTiNENCT03120507

Resuscitation Outcomes in the Netherlands

An observational study of Heart Arrest and Cardiac Arrest, run by Erasmus Medical Center at 12 sites in Netherlands.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
How many people
700 participants
Where
12 sitesNetherlands
Study dates
1 Jan 2017to 1 Jul 2019
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
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: 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.

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

12 sites in 1 country.

12 sites in 1 country

Netherlands12 sites
  • OLVG

    Amsterdam, North Holland, 1091AC

  • Rijnstate Ziekenhuis

    Arnhem, Gelderland, 6815AD

  • Amphia Ziekenhuis

    Breda, South Holland, 4818CK

  • Reinier de Graaf Gasthuis

    Delft, South Holland, 2625AD

  • Deventer Ziekenhuis

    Deventer, Overijssel, 7416SE

  • Albert Schweitzer Ziekenhuis

    Dordrecht, South Holland, 3318AT

  • Medisch Spectrum Twente

    Enschede, Overijssel, 7512KZ

  • Sint Franciscus Vlietland Groep

    Rotterdam, South Holland, 3045PM

  • Maasstad Ziekenhuis

    Rotterdam, South Holland, 3079DZ

  • ZorgSaam Zeeuws-Vlaanderen

    Terneuzen, Zeeland, 4535PA

  • Haaglanden Medisch Centrum

    The Hague, South Holland

  • Isala klinieken

    Zwolle, Overijssel, 8025AB

Other trials in Netherlands

About this study

Official title: 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.

Read the detailed description

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.

Keywords
in-hospital cardiac arrest, IHCA, quality of life, QoL, patient-reported outcomes
Medical subject headings
Heart Arrest, Cognitive Dysfunction

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. one-year survival

    Survival one year after in-hospital cardiac arrest

    Measured: one year

Secondary outcomes (8)
  1. SF-12

    Quality of life measured by SF-12 questionnaire

    Measured: 3 months and one year after in-hospital cardiac arrest

  2. EuroQoL

    Quality of life measured by EuroQoL questionnaire

    Measured: 3 months and one year after in-hospital cardiac arrest

  3. HADS

    Quality of life measured by Hospital Anxiety and Depression Scale questionnaire

    Measured: 3 months and one year after in-hospital cardiac arrest

  4. Charlson Comorbidity Index

    Development of new comorbidities as defined by the Charlson Comorbidity Index.

    Measured: 3 months and one year after in-hospital cardiac arrest

  5. Cardiovascular events

    Development of new cardiovascular events (e.g. myocardial infarction, stroke), by means of checkbox question.

    Measured: 3 months and one year after in-hospital cardiac arrest

  6. Working life

    Participation in working life; status before cardiac arrest and after by means of checkbox question.

    Measured: Prior to in-hospital cardiac arrest and 3 months and one year after in-hospital cardiac arrest

  7. TICS

    Telephonic interview for Cognitive Status

    Measured: 3 months after in-hospital cardiac arrest, if patients are not able to respond to regular questionnaires (paper)

  8. CSI

    Caregiver strain index for caregivers of In-Hospital Cardiac Arrest Survivors

    Measured: 3 months and one year after in-hospital cardiac arrest

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Apr 2017
  2. Study start1 Jan 2017
  3. Primary completion1 Jun 2019
  4. Study completion1 Jul 2019

Resources

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
700 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03120507
Sponsor's protocol ID
ABR55661.078.16
Other IDs
NTR6145, MEC-2016-563
Acronym
ROUTiNE
Status last verified
Jul 2019
First submitted
6 Apr 2017
Last updated
16 Jul 2019
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Heart Arrest and Cardiac Arrest, run by Erasmus Medical Center at 12 sites in Netherlands.

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 3 inclusion and 5 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: finished, as of the sponsor's last update on 16 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

one-year survival (time frame: one year). 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 16 Jul 2019.

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