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NCT01239420 Clinical Trial

Norwegian Cardio-Respiratory Arrest Study

Cardiac Arrest Clinical Trial

— NORCAST  

Official title:
Norwegian Cardio-Respiratory Arrest Study (NORCAST)

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT01239420
Other study ID # REK S-O A Ref 2010/1116a
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date September 2010
Est. completion date December 2028

Study information
Verified date April 2024
Source Oslo University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The purpose of this study is to evaluate the use of combined clinical-neurological, neurophysiologic, neuroradiological and biochemical markers in prognostication after cardio- and/or respiratory arrest.

Description:

Cardiac arrest (CA) is a leading cause of death, affecting about 700.000 individuals each year in Europe. Acute Myocardial Infarction (AMI) and primary arrhythmia are the most common causes of CA, whereas respiratory arrest is a leading cause of secondary CA. Patients who have undergone cardiopulmonary resuscitation (CPR) often remain unconscious after hospital admission, either as a result of severe permanent brain damage or a merely reversible metabolic disturbance due to post-ischemic global reperfusion. Early prediction of neurological and cardiac outcome remains a difficult task for physicians. The decision to continue, limit or terminate intensive care therapy carries huge ethical and socioeconomic implications. Optimal emergency cardiovascular care, cardiac failure therapy and CA prevention after hospitalisation also remain difficult issues for cardiologists and intensive care doctors. In this prospective study running from 2010, both prognostication and in-hospital treatment are studied in a population of 261 patients with out-of-hospital cardio-respiratory arrest. The use of combined clinical-neurological, neurophysiologic, neuroradiological and biochemical markers is studied to asses whether a poor neurological outcome (Cerebral Performance Category 3-5) can be predicted with ~100% specificity and a sensitivity that is sufficient for practical clinical use. Pre-disposing and triggering causes of cardiorespiratory arrest are also registered. Patients with pre-existing conditions coherent with prophylactic ICD implementation under current international guidelines will be identified, in order to assess and further improve ICD-prophylactic treatment in Norway. The potential benefit of invasive PICCO-monitoring after CA will also be evaluated, and a subproject identifying biomarkers for CA risk has been established. NIRS (Near-Infrared spectroscopy) will also be used to register cerebral oxygenation in the early days after cardiorespiratory arrest. The overall aim of the NORCAST study is to provide physicians with better tools to asses cardiac and neurological outcome as early and as accurate as possible. All alive study patients are invited to long-term follow-up consultaions after 6 months, after 4 years, and after 10 years. The consultations will include study examinations, structured interviews and questionnaires. Questionnaires will also be used for next of kin.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 261
Est. completion date December 2028
Est. primary completion date August 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - prehospital cardial resuscitation - prehospital pulmonary resuscitation - ROSC before/on admission to hospital - > 18 years of age Exclusion Criteria: - death on admission to hospital - arrhythmic cardiac arrest with ALS < 5min and spontaneous awakening - in-hospital cardiac arrest - trauma patients

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Norway Oslo University Hospital - Ulleval Oslo

Sponsors (1)
Lead Sponsor Collaborator
Oslo University Hospital

Country where clinical trial is conducted

Norway, 

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