Clinical trial NCT03120507: Resuscitation Outcomes in the Netherlands
Official title: Resuscitation Outcomes in the Netherlands Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
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
Lead sponsor: Erasmus Medical Center
Sponsor class: OTHER
First posted: 2017-04-19
Enrollment: 700
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

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.

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.

Primary outcomes:
measure: one-year survival
timeFrame: one year
Secondary outcomes:
measure: SF-12
timeFrame: 3 months and one year after in-hospital cardiac arrest
measure: EuroQoL
timeFrame: 3 months and one year after in-hospital cardiac arrest
measure: HADS
timeFrame: 3 months and one year after in-hospital cardiac arrest
measure: Charlson Comorbidity Index
timeFrame: 3 months and one year after in-hospital cardiac arrest
measure: Cardiovascular events
timeFrame: 3 months and one year after in-hospital cardiac arrest
measure: Working life
timeFrame: Prior to in-hospital cardiac arrest and 3 months and one year after in-hospital cardiac arrest
measure: TICS
timeFrame: 3 months after in-hospital cardiac arrest, if patients are not able to respond to regular questionnaires (paper)
measure: CSI
timeFrame: 3 months and one year after in-hospital cardiac arrest
Other outcomes:
Locations:
city: Arnhem
country: Netherlands
facility: Rijnstate Ziekenhuis
state: Gelderland
city: Amsterdam
country: Netherlands
facility: OLVG
state: Noord-Holland
city: Deventer
country: Netherlands
facility: Deventer Ziekenhuis
state: Overijssel
city: Enschede
country: Netherlands
facility: Medisch Spectrum Twente
state: Overijssel
city: Zwolle
country: Netherlands
facility: Isala klinieken
state: Overijssel
city: Terneuzen
country: Netherlands
facility: ZorgSaam Zeeuws-Vlaanderen
state: Zeeland
city: Breda
country: Netherlands
facility: Amphia Ziekenhuis
state: Zuid-Holland
city: Delft
country: Netherlands
facility: Reinier de Graaf Gasthuis
state: Zuid-Holland
city: Dordrecht
country: Netherlands
facility: Albert Schweitzer Ziekenhuis
state: Zuid-Holland
city: Rotterdam
country: Netherlands
facility: Sint Franciscus Vlietland Groep
state: Zuid-Holland
city: Rotterdam
country: Netherlands
facility: Maasstad Ziekenhuis
state: Zuid-Holland
city: The Hague
country: Netherlands
facility: Haaglanden Medisch Centrum
state: Zuid-Holland
Study officials:
affiliation: Erasmus Medical Center
name: Robert Jan Stolker, MD PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Erasmus Medical Center
name: Marc Schluep, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Erasmus Medical Center
name: Sanne Hoeks, PhD
role: STUDY_CHAIR
affiliation: OLVG
name: Henrik Endeman, MD PhD
role: STUDY_CHAIR
References: