Resuscitation Outcomes in the Netherlands (ROUTiNE)
Resuscitation Outcomes in the Netherlands Study
研究概览
详细说明
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.
研究类型
注册 (实际的)
联系人和位置
学习地点
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Gelderland
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Arnhem、Gelderland、荷兰、6815AD
- Rijnstate Ziekenhuis
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Noord-Holland
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Amsterdam、Noord-Holland、荷兰、1091AC
- OLVG
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Overijssel
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Deventer、Overijssel、荷兰、7416SE
- Deventer Ziekenhuis
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Enschede、Overijssel、荷兰、7512KZ
- Medisch Spectrum Twente
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Zwolle、Overijssel、荷兰、8025AB
- Isala Klinieken
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Zeeland
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Terneuzen、Zeeland、荷兰、4535PA
- Zorgsaam Zeeuws-Vlaanderen
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Zuid-Holland
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Breda、Zuid-Holland、荷兰、4818CK
- Amphia Ziekenhuis
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Delft、Zuid-Holland、荷兰、2625AD
- Reinier de Graaf Gasthuis
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Dordrecht、Zuid-Holland、荷兰、3318AT
- Albert Schweitzer Ziekenhuis
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Rotterdam、Zuid-Holland、荷兰、3079DZ
- Maasstad Ziekenhuis
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Rotterdam、Zuid-Holland、荷兰、3045PM
- Sint Franciscus Vlietland Groep
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The Hague、Zuid-Holland、荷兰
- Haaglanden Medisch Centrum
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
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.
学习计划
研究是如何设计的？
设计细节
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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one-year survival
大体时间：one year
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Survival one year after in-hospital cardiac arrest
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one year
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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SF-12
大体时间：3 months and one year after in-hospital cardiac arrest
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Quality of life measured by SF-12 questionnaire
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3 months and one year after in-hospital cardiac arrest
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EuroQoL
大体时间：3 months and one year after in-hospital cardiac arrest
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Quality of life measured by EuroQoL questionnaire
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3 months and one year after in-hospital cardiac arrest
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HADS
大体时间：3 months and one year after in-hospital cardiac arrest
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Quality of life measured by Hospital Anxiety and Depression Scale questionnaire
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3 months and one year after in-hospital cardiac arrest
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Charlson Comorbidity Index
大体时间：3 months and one year after in-hospital cardiac arrest
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Development of new comorbidities as defined by the Charlson Comorbidity Index.
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3 months and one year after in-hospital cardiac arrest
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Cardiovascular events
大体时间：3 months and one year after in-hospital cardiac arrest
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Development of new cardiovascular events (e.g.
myocardial infarction, stroke), by means of checkbox question.
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3 months and one year after in-hospital cardiac arrest
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Working life
大体时间：Prior to in-hospital cardiac arrest and 3 months and one year after in-hospital cardiac arrest
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Participation in working life; status before cardiac arrest and after by means of checkbox question.
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Prior to in-hospital cardiac arrest and 3 months and one year after in-hospital cardiac arrest
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TICS
大体时间：3 months after in-hospital cardiac arrest, if patients are not able to respond to regular questionnaires (paper)
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Telephonic interview for Cognitive Status
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3 months after in-hospital cardiac arrest, if patients are not able to respond to regular questionnaires (paper)
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CSI
大体时间：3 months and one year after in-hospital cardiac arrest
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Caregiver strain index for caregivers of In-Hospital Cardiac Arrest Survivors
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3 months and one year after in-hospital cardiac arrest
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合作者和调查者
调查人员
- 首席研究员：Robert Jan Stolker, MD PhD、Erasmus Medical Center
- 首席研究员：Marc Schluep, MD、Erasmus Medical Center
- 学习椅：Sanne Hoeks, PhD、Erasmus Medical Center
- 学习椅：Henrik Endeman, MD PhD、OLVG
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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生活质量的临床试验
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Swansea University完全的
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Yale-NUS College完全的
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Scripps Translational Science Institute完全的
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Peking Union Medical College Hospital尚未招聘