Cardiac ArrestNORCASTNCT01239420
Norwegian Cardio-Respiratory Arrest Study
An observational study of Cardiac Arrest and Respiratory Arrest, run by Oslo University Hospital at 1 site in Norway.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Arrest, Respiratory Arrest, Coma
- How many people
- 261 participants
- Where
- 1 siteNorway
- Study dates
- Sep 2010to Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients admitted after pre-hospital cardio/respiratory arrest.
Who may be able to join
- prehospital cardial resuscitation
- prehospital pulmonary resuscitation
- ROSC before/on admission to hospital
- > 18 years of age
Who cannot join
- death on admission to hospital
- arrhythmic cardiac arrest with ALS < 5min and spontaneous awakening
- in-hospital cardiac arrest
- trauma patients
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Cardiac Arrest, Respiratory Arrest, Coma
- Medical subject headings
- Heart Arrest, Apnea, Coma
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2010 (estimated)
- Study startSep 2010
- Primary completionAug 2018
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Cardiac ArrestStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 261 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Espen Rostrup Nakstad, Oslo University Hospital
- Investigators
- Dag Jacobsen, MD, PhD, Study director, Oslo University Hospital - Ulleval, NorwayKjetil Sunde, MD, PhD, Study director, Oslo University Hospital - Ulleval, Norway
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01239420
- Sponsor's protocol ID
- REK S-O A Ref 2010/1116a
- Acronym
- NORCAST
- Status last verified
- Apr 2024
- First submitted
- 10 Nov 2010
- Last updated
- 5 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
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.
PubMed 31205786Beitland 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.
PubMed 27716377Staer-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.
PubMed 26453688
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Norwegian Cardio-Respiratory Arrest Study (NORCAST)
- ClinicalTrials.gov ID
- NCT01239420
- Acronym / sponsor ID
- NORCAST / REK S-O A Ref 2010/1116a
- Conditions
- Cardiac Arrest, Respiratory Arrest, Coma
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 261 participants (actual)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Study start
- Sep 2010
- Primary completion
- Aug 2018 (actual)
- Study completion
- Dec 2028 (estimated)
- First posted
- 11 Nov 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients admitted after pre-hospital cardio/respiratory arrest.
Key inclusion criteria (4 listed)
- prehospital cardial resuscitation
- prehospital pulmonary resuscitation
- ROSC before/on admission to hospital
- > 18 years of age
Key exclusion criteria (4 listed)
- death on admission to hospital
- arrhythmic cardiac arrest with ALS < 5min and spontaneous awakening
- in-hospital cardiac arrest
- trauma patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2024.
- Derived from this study: PubMed 31205786Beitland 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.
- Derived from this study: PubMed 27716377Beitland 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.
- Derived from this study: PubMed 26453688Staer-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.
- Individual participant dataSharing planned: Undecided
Related trials for Cardiac Arrest
RecruitingObservational study
Observational Study of Cardiac Arrhythmias During Treatment With BTK Inhibitors or Venetoclax
Chronic Lymphocytic Leukemia (CLL), Waldenstr(SqrRoot)(Delta)m s Macroglobulinemia
Active, not recruiting
The REVIVE-PEEP Trial: Positive End-expiratory Pressure Versus Sham Valve/Zero End-expiratory Pressure in Cardiopulmonary Resuscitation During Manual Ventilation to Improve Neurological Outcomes at Discharge in Adult Patients Suffering an Out-of-hospital Cardiac Arrest
Cardiac Arrest, Out-Of-Hospital
RecruitingObservational study
Accuracy of Doppler Ultrasound Versus Manual Palpation of Pulse in Cardiac Arrest
Cardiac Arrest
Active, not recruiting
RACE-CARS - RAndomized Cluster Evaluation of Cardiac ARrest Systems
Cardiac Arrest
Not yet recruitingObservational study
Therapeutic Outcomes of In-Hospital Resuscitation of Patients Admitted to the Internal Medicine Wards
Survival to Discharge With Good Neurologic Outcome Among in Hospital Cardiac Arrest Patients
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dag Jacobsen, MD, PhD study director
Oslo University Hospital - Ulleval, Norway
Kjetil Sunde, MD, PhD study director
Oslo University Hospital - Ulleval, Norway
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiac Arrest and Respiratory Arrest, run by Oslo University Hospital at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 5 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01239420, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2024.