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.
|Study Design:||Observational Model: Case Control
Time Perspective: Prospective
|Official Title:||Norwegian Cardio-Respiratory Arrest Study (NORCAST)|
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).
|Study Start Date:||September 2010|
|Estimated Study Completion Date:||December 2014|
|Estimated Primary Completion Date:||December 2014 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01239420
|Contact: Espen R Nakstad, MD||+47 22 11 91 firstname.lastname@example.org|
|Contact: Henrik Stær-Jensen, MD||+47 22 11 91 email@example.com|
|Oslo University Hospital - Ulleval||Recruiting|
|Oslo, Norway, 0407|
|Contact: Espen R Nakstad, MD +47 22 11 91 01 firstname.lastname@example.org|
|Contact: Henrik Staer-Jensen, MD +47 22 11 91 01 email@example.com|
|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|