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Norwegian Cardio-Respiratory Arrest Study (NORCAST)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01239420
Recruitment Status : Active, not recruiting
First Posted : November 11, 2010
Last Update Posted : February 24, 2021
Sponsor:
Information provided by (Responsible Party):
Espen Rostrup Nakstad, Oslo University Hospital

Tracking Information
First Submitted Date November 10, 2010
First Posted Date November 11, 2010
Last Update Posted Date February 24, 2021
Study Start Date September 2010
Actual Primary Completion Date August 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures Not Provided
Original Primary Outcome Measures Not Provided
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Norwegian Cardio-Respiratory Arrest Study
Official Title Norwegian Cardio-Respiratory Arrest Study (NORCAST)
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.
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
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
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).
Sampling Method Probability Sample
Study Population Patients admitted after pre-hospital cardio/respiratory arrest.
Condition
  • Cardiac Arrest
  • Respiratory Arrest
  • Coma
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Actual Enrollment
 (submitted: September 26, 2016)
261
Original Estimated Enrollment
 (submitted: November 10, 2010)
250
Estimated Study Completion Date December 2028
Actual Primary Completion Date August 2018   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Norway
Removed Location Countries  
 
Administrative Information
NCT Number NCT01239420
Other Study ID Numbers REK S-O A Ref 2010/1116a
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Espen Rostrup Nakstad, Oslo University Hospital
Study Sponsor Oslo University Hospital
Collaborators Not Provided
Investigators
Study Director: Dag Jacobsen, MD, PhD Oslo University Hospital - Ulleval, Norway
Study Director: Kjetil Sunde, MD, PhD Oslo University Hospital - Ulleval, Norway
PRS Account Oslo University Hospital
Verification Date February 2021