Norwegian Cardio-Respiratory Arrest Study (NORCAST)
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition |
|---|
|
Cardiac Arrest Respiratory Arrest Resuscitation Coma |
| Study Type: | Observational |
| 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).
| Estimated Enrollment: | 250 |
| 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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
Patients admitted after pre-hospital cardio/respiratory arrest.
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
Contacts and Locations| 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 | |
| Oslo University Hospital - Ulleval | Recruiting |
| Oslo, Norway, 0407 | |
| Contact: Espen R Nakstad, MD +47 22 11 91 01 naes@uus.no | |
| Contact: Henrik Staer-Jensen, MD +47 22 11 91 01 henrik.staer-jensen@uus.no | |
| 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 |
More Information
No publications provided
| Responsible Party: | Espen Rostrup Nakstad, MD, Oslo University Hospital |
| ClinicalTrials.gov Identifier: | NCT01239420 History of Changes |
| Other Study ID Numbers: | REK S-O A Ref 2010/1116a |
| Study First Received: | November 10, 2010 |
| Last Updated: | January 12, 2013 |
| Health Authority: | Norway: Regional Ethics Commitee |
Additional relevant MeSH terms:
|
Apnea Heart Arrest Respiration Disorders Respiratory Tract Diseases |
Signs and Symptoms, Respiratory Signs and Symptoms Heart Diseases Cardiovascular Diseases |
ClinicalTrials.gov processed this record on May 19, 2013