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
  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)

Resource links provided by NLM:


Further study details as provided by Oslo University Hospital:

Biospecimen Retention:   Samples With DNA

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)
Detailed 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 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
Study Population

Patients admitted after pre-hospital cardio/respiratory arrest.

Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01239420

Contacts
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

Locations
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   
Sponsors and Collaborators
Oslo University Hospital
Investigators
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:
Heart Arrest
Apnea
Heart Diseases
Cardiovascular Diseases
Respiration Disorders
Respiratory Tract Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms

ClinicalTrials.gov processed this record on September 30, 2014