Resuscitation Outcomes in the Netherlands

Quality of Life Clinical Trial

— ROUTiNE  

Official title:

Resuscitation Outcomes in the Netherlands Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03120507
• Other study ID #: ABR55661.078.16
• Secondary ID: NTR6145MEC-2016-
• Status: Completed
• 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
• 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.

Related Conditions & MeSH terms

• Cardiac Arrest
• Cardiac Arrest as A Complication of Care
• Cognitive Dysfunction
• Cognitive Impairment
• Heart Arrest
• Outcome, Fatal
• Quality of Life

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

External Links

•   Study website/patient information