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.
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
- Conditions the study is for
- Heart Arrest, Cardiac Arrest, Cardiac Arrest as A Complication of Care
- 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
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.
- Conditions
- Heart Arrest, Cardiac Arrest, Cardiac Arrest as A Complication of Care, Outcome, Fatal, Quality of Life, Cognitive Impairment
- 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.
one-year survival
Survival one year after in-hospital cardiac arrest
Measured: one year
Secondary outcomes (8)
SF-12
Quality of life measured by SF-12 questionnaire
Measured: 3 months and one year after in-hospital cardiac arrest
EuroQoL
Quality of life measured by EuroQoL questionnaire
Measured: 3 months and one year after in-hospital cardiac arrest
HADS
Quality of life measured by Hospital Anxiety and Depression Scale questionnaire
Measured: 3 months and one year after in-hospital cardiac arrest
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
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
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
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)
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.
- First posted19 Apr 2017
- Study start1 Jan 2017
- Primary completion1 Jun 2019
- Study completion1 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart ArrestStudies of the same condition, open and under way.
- More trials run by Erasmus Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Erasmus Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marc Schluep, Erasmus Medical Center
- Investigators
- Robert Jan Stolker, MD PhD, Principal investigator, Erasmus Medical CenterMarc Schluep, MD, Principal investigator, Erasmus Medical CenterSanne Hoeks, PhD, Study chair, Erasmus Medical CenterHenrik Endeman, MD PhD, Study chair, OLVG
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
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Resuscitation Outcomes in the Netherlands Study
- ClinicalTrials.gov ID
- NCT03120507
- Acronym / sponsor ID
- ROUTiNE / ABR55661.078.16
- Conditions
- Heart Arrest, Cardiac Arrest, Cardiac Arrest as A Complication of Care, Outcome, Fatal, Quality of Life, Cognitive Impairment
- Keywords
- in-hospital cardiac arrest, IHCA, quality of life, QoL, patient-reported outcomes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 700 participants (actual)
- Lead sponsor
- Erasmus Medical CenterUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 1 Jun 2019 (actual)
- Study completion
- 1 Jul 2019 (actual)
- First posted
- 19 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
one-year survival
Time frame: one year
Survival one year after in-hospital cardiac arrest
8 secondary outcomes
SF-12
Time frame: 3 months and one year after in-hospital cardiac arrest
EuroQoL
Time frame: 3 months and one year after in-hospital cardiac arrest
HADS
Time frame: 3 months and one year after in-hospital cardiac arrest
Charlson Comorbidity Index
Time frame: 3 months and one year after in-hospital cardiac arrest
Cardiovascular events
Time frame: 3 months and one year after in-hospital cardiac arrest
Working life
Time frame: Prior to in-hospital cardiac arrest and 3 months and one year after in-hospital cardiac arrest
TICS
Time frame: 3 months after in-hospital cardiac arrest, if patients are not able to respond to regular questionnaires (paper)
CSI
Time frame: 3 months and one year after in-hospital cardiac arrest
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert Jan Stolker, MD PhD principal investigator
Erasmus Medical Center
Marc Schluep, MD principal investigator
Erasmus Medical Center
Sanne Hoeks, PhD study chair
Erasmus Medical Center
12 sites in 1 country: see every site and its status.
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.