Norwegian Cardio-Respiratory Arrest Study (NORCAST)

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
• Conditions: Cardiac Arrest; Coma; Respiratory Arrest

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

Study Locations

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

Participation Criteria

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

How is the study designed?

Design Details

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

Collaborators and Investigators

• Sponsor: 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

Publications and helpful links

General Publications

• Beitland S, Nakstad ER, Berg JP, Troseid AS, Brusletto BS, Brunborg C, Lundqvist C, Sunde K. Urine beta-2-Microglobulin, Osteopontin, and Trefoil Factor 3 May Early Predict Acute Kidney Injury and Outcome after Cardiac Arrest. Crit Care Res Pract. 2019 May 7;2019:4384796. doi: 10.1155/2019/4384796. eCollection 2019.
• Beitland S, Waldum-Grevbo BE, Nakstad ER, Berg JP, Troseid AS, Brusletto BS, Brunborg C, Andersen GO, Sunde K. Urine biomarkers give early prediction of acute kidney injury and outcome after out-of-hospital cardiac arrest. Crit Care. 2016 Oct 5;20(1):314. doi: 10.1186/s13054-016-1503-2.
• Staer-Jensen H, Nakstad ER, Fossum E, Mangschau A, Eritsland J, Draegni T, Jacobsen D, Sunde K, Andersen GO. Post-Resuscitation ECG for Selection of Patients for Immediate Coronary Angiography in Out-of-Hospital Cardiac Arrest. Circ Cardiovasc Interv. 2015 Oct;8(10):e002784. doi: 10.1161/CIRCINTERVENTIONS.115.002784.

Study record dates

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: Heart Diseases; Cardiovascular Diseases; Heart Arrest
• 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