NORCAST: Norwegian Cardio-Respiratory Arrest Study

Sponsor
Oslo University Hospital (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT01239420
Collaborator
(none)
261
1
219
1.2

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase

    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 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.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    261 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Prospective
    Official Title:
    Norwegian Cardio-Respiratory Arrest Study (NORCAST)
    Study Start Date :
    Sep 1, 2010
    Actual Primary Completion Date :
    Aug 1, 2018
    Anticipated Study Completion Date :
    Dec 1, 2028

    Outcome Measures

    Primary Outcome Measures

      Eligibility Criteria

      Criteria

      Ages Eligible for Study:
      18 Years and Older
      Sexes Eligible for Study:
      All
      Accepts Healthy Volunteers:
      No
      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

      Locations

      Site City State Country Postal Code
      1 Oslo University Hospital - Ulleval Oslo Norway 0407

      Sponsors and Collaborators

      • Oslo University Hospital

      Investigators

      • Study Director: Dag Jacobsen, MD, PhD, Oslo University Hospital - Ulleval, Norway
      • Study Director: Kjetil Sunde, MD, PhD, Oslo University Hospital - Ulleval, Norway

      Study Documents (Full-Text)

      None provided.

      More Information

      Publications

      None provided.
      Responsible Party:
      Espen Rostrup Nakstad, MD, Oslo University Hospital
      ClinicalTrials.gov Identifier:
      NCT01239420
      Other Study ID Numbers:
      • REK S-O A Ref 2010/1116a
      First Posted:
      Nov 11, 2010
      Last Update Posted:
      Feb 24, 2021
      Last Verified:
      Feb 1, 2021
      Individual Participant Data (IPD) Sharing Statement:
      Undecided
      Plan to Share IPD:
      Undecided
      Additional relevant MeSH terms:

      Study Results

      No Results Posted as of Feb 24, 2021