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Norwegian Cardio-Respiratory Arrest Study (NORCAST)

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2011 by Oslo University Hospital
Sponsor:
Information provided by (Responsible Party):
Espen Rostrup Nakstad, Oslo University Hospital
ClinicalTrials.gov Identifier:
NCT01239420
First received: November 10, 2010
Last updated: January 12, 2013
Last verified: May 2011

November 10, 2010
January 12, 2013
September 2010
December 2014   (final data collection date for primary outcome measure)
Not Provided
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Complete list of historical versions of study NCT01239420 on ClinicalTrials.gov Archive Site
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Norwegian Cardio-Respiratory Arrest Study
Norwegian Cardio-Respiratory Arrest Study (NORCAST)

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.

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 150-250 patients with out-of-hospital cardio-respiratory arrest. The use of combined clinical-neurological, neurophysiologic, neuroradiological and biochemical markers will be 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 will also be 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.

Observational
Observational Model: Case Control
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

Serum, plasma, blood (PaxGene). For future identification of biochemical markers in prognostication after cardiorespiratory arrest. For future identification of biochemical markers for cardiac arrest (primarily serum, but also on mRNA-level).

Probability Sample

Patients admitted after pre-hospital cardio/respiratory arrest.

  • Cardiac Arrest
  • Respiratory Arrest
  • Resuscitation
  • Coma
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
250
December 2014
December 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Espen R Nakstad, MD +47 22 11 91 01 naes@uus.no
Contact: Henrik Stær-Jensen, MD +47 22 11 91 01 henrik.staer-jensen@uus.no
Norway
 
NCT01239420
REK S-O A Ref 2010/1116a
No
Espen Rostrup Nakstad, Oslo University Hospital
Oslo University Hospital
Not Provided
Study Director: Dag Jacobsen, MD, PhD Oslo University Hospital - Ulleval, Norway
Study Director: Arild Mangschau, MD, PhD Oslo University Hospital - Ulleval, Norway
Study Director: Kjetil Sunde, MD, PhD Oslo University Hospital - Ulleval, Norway
Oslo University Hospital
May 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP