Resuscitation Outcomes in the Netherlands

NCT ID: NCT03120507

Last Updated: 2019-07-16

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 700 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-01-01
• Study Completion Date: 2019-07-01

Brief 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.

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Erasmus Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Marc Schluep

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Robert Jan Stolker, MD PhD

Role: PRINCIPAL_INVESTIGATOR

Erasmus Medical Center

Marc Schluep, MD

Role: PRINCIPAL_INVESTIGATOR

Erasmus Medical Center

Sanne Hoeks, PhD

Role: STUDY_CHAIR

Erasmus Medical Center

Henrik Endeman, MD PhD

Role: STUDY_CHAIR

OLVG

Locations

Rijnstate Ziekenhuis

Arnhem, Gelderland, Netherlands

OLVG

Amsterdam, North Holland, Netherlands

Deventer Ziekenhuis

Deventer, Overijssel, Netherlands

Medisch Spectrum Twente

Enschede, Overijssel, Netherlands

Isala klinieken

Zwolle, Overijssel, Netherlands

Amphia Ziekenhuis

Breda, South Holland, Netherlands

Reinier de Graaf Gasthuis

Delft, South Holland, Netherlands

Albert Schweitzer Ziekenhuis

Dordrecht, South Holland, Netherlands

Sint Franciscus Vlietland Groep

Rotterdam, South Holland, Netherlands

Maasstad Ziekenhuis

Rotterdam, South Holland, Netherlands

Haaglanden Medisch Centrum

The Hague, South Holland, Netherlands

ZorgSaam Zeeuws-Vlaanderen

Terneuzen, Zeeland, Netherlands

Countries

Netherlands

Other Identifiers

NTR6145

Identifier Type: OTHER

Identifier Source: secondary_id

MEC-2016-563

Identifier Type: OTHER

Identifier Source: secondary_id

ABR55661.078.16

Identifier Type: -

Identifier Source: org_study_id