Norwegian Cardio-Respiratory Arrest Study (NORCAST)

April 4, 2024 updated by: Espen Rostrup Nakstad, Oslo University Hospital

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 Overview

Status

Active, not recruiting

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 Type

Observational

Enrollment (Actual)

261

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Oslo, Norway, 0407
        • Oslo University Hospital - Ulleval

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Patients admitted after pre-hospital cardio/respiratory arrest.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2010

Primary Completion (Actual)

August 1, 2018

Study Completion (Estimated)

December 1, 2028

Study Registration Dates

First Submitted

November 10, 2010

First Submitted That Met QC Criteria

November 10, 2010

First Posted (Estimated)

November 11, 2010

Study Record Updates

Last Update Posted (Actual)

April 5, 2024

Last Update Submitted That Met QC Criteria

April 4, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • REK S-O A Ref 2010/1116a

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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