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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03120507
Other study ID # ABR55661.078.16
Secondary ID NTR6145MEC-2016-
Status Completed
Phase
First received
Last updated
Start date January 1, 2017
Est. completion date July 1, 2019

Study information

Verified date July 2019
Source Erasmus Medical Center
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 700
Est. completion date July 1, 2019
Est. primary completion date June 1, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Locations

Country Name City State
Netherlands OLVG Amsterdam Noord-Holland
Netherlands Rijnstate Ziekenhuis Arnhem Gelderland
Netherlands Amphia Ziekenhuis Breda Zuid-Holland
Netherlands Reinier de Graaf Gasthuis Delft Zuid-Holland
Netherlands Deventer Ziekenhuis Deventer Overijssel
Netherlands Albert Schweitzer Ziekenhuis Dordrecht Zuid-Holland
Netherlands Medisch Spectrum Twente Enschede Overijssel
Netherlands Maasstad Ziekenhuis Rotterdam Zuid-Holland
Netherlands Sint Franciscus Vlietland Groep Rotterdam Zuid-Holland
Netherlands ZorgSaam Zeeuws-Vlaanderen Terneuzen Zeeland
Netherlands Haaglanden Medisch Centrum The Hague Zuid-Holland
Netherlands Isala klinieken Zwolle Overijssel

Sponsors (1)

Lead Sponsor Collaborator
Erasmus Medical Center

Country where clinical trial is conducted

Netherlands, 

Outcome

Type Measure Description Time frame Safety issue
Primary one-year survival Survival one year after in-hospital cardiac arrest one year
Secondary SF-12 Quality of life measured by SF-12 questionnaire 3 months and one year after in-hospital cardiac arrest
Secondary EuroQoL Quality of life measured by EuroQoL questionnaire 3 months and one year after in-hospital cardiac arrest
Secondary HADS Quality of life measured by Hospital Anxiety and Depression Scale questionnaire 3 months and one year after in-hospital cardiac arrest
Secondary Charlson Comorbidity Index Development of new comorbidities as defined by the Charlson Comorbidity Index. 3 months and one year after in-hospital cardiac arrest
Secondary Cardiovascular events 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
Secondary Working life 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
Secondary TICS Telephonic interview for Cognitive Status 3 months after in-hospital cardiac arrest, if patients are not able to respond to regular questionnaires (paper)
Secondary CSI Caregiver strain index for caregivers of In-Hospital Cardiac Arrest Survivors 3 months and one year after in-hospital cardiac arrest
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