Cardiopulmonary Arrest OutcomeNCT00814814
Protein S100 Beta as a Predictor of Resuscitation Outcome
An observational study of Cardiopulmonary Arrest Outcome, run by Shaare Zedek Medical Center at 2 sites in Israel.
Trial summary
Management of cardiac arrest is complicated by the lack of a readily available tool identifying individuals who are likely to be successfully resuscitated. S100 beta is a protein that originates in the astroglial cells of the brain, and NSE (Neuron Specific Enolase) is another protein that originates in the neurons… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiopulmonary Arrest Outcome
- How many people
- 313 participants
- Where
- 2 sitesIsrael
- Study dates
- Feb 2008to Nov 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
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: All victims of non-traumatic out-of hospital cardiopulmonary arrest (defined as the absence of either spontaneous respiration or palpable pulse or both) within the Jerusalem district.
Who may be able to join
- All victims of non-traumatic out-of hospital cardiopulmonary arrest (defined as the absence of either spontaneous respiration or palpable pulse or both) within the Jerusalem district.
Who cannot join
- Patients with do-not-resuscitate orders or an advance directive to that effect.
- Patients with intracranial hemorrhage
Trial locations and contacts
2 sites in 1 country.
Israel2 sites
Shaare Zedek Medical Center
Jerusalem, 91031
Hadassah Medical Center
Jerusalem, 91120
About this study
Official title: Protein S100 Beta as a Predictor of the Outcome of Cardiopulmonary Resuscitation
Management of cardiac arrest is complicated by the lack of a readily available tool identifying individuals who are likely to be successfully resuscitated. S100 beta is a protein that originates in the astroglial cells of the brain, and NSE (Neuron Specific Enolase) is another protein that originates in the neurons themselves. In the laboratory, the concentration of these proteins correlate with evidence of brain damage after head trauma, stroke and exposure to low levels of oxygen. The concentration of these proteins in the blood of human survivors of cardiopulmonary resuscitation in humans is much higher than in patients who were resuscitated but did not survive. However, it is still unclear whether survivors from cardiopulmonary resuscitation have higher levels of these proteins in their blood if they survive with neurological injury secondary to the arrest and resuscitation.
Hypothesis: In humans, the blood concentrations of protein S100 beta and NSE during and after resuscitation can predict who will die despite cardiopulmonary resuscitation and who will survive with neurological injury secondary to the arrest and resuscitation.
- Conditions
- Cardiopulmonary Arrest Outcome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cardiopulmonary arrest | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Poor versus good patient outcome at discharge was used to test the study hypotheses of improved prediction attributable to S100B and NSE concentration.
Measured: within 24 hours of discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Dec 2008 (estimated)
- Study startFeb 2008
- Primary completionNov 2021 (estimated)
- Study completionNov 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Cardiopulmonary Arrest OutcomeStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Other
- Enrolment
- 313 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shaare Zedek Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Sharon Einav, Shaare Zedek Medical Center
- Investigators
- Sharon Einav, MD, Principal investigator, Shaare Zedek Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00814814
- Sponsor's protocol ID
- 14-01-05 A and B (correction)
- Status last verified
- Nov 2020
- First submitted
- 24 Dec 2008
- Last updated
- 16 Nov 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes
Publications
Einav S, Kaufman N, Algur N, Strauss-Liviatan N, Kark JD. Brain biomarkers and management of uncertainty in predicting outcome of cardiopulmonary resuscitation: a nomogram paints a thousand words. Resuscitation. 2013 Aug;84(8):1083-8. doi: 10.1016/j.resuscitation.2013.01.031. Epub 2013 Feb 4.
PubMed 23391666Einav S, Kaufman N, Algur N, Kark JD. Modeling serum biomarkers S100 beta and neuron-specific enolase as predictors of outcome after out-of-hospital cardiac arrest: an aid to clinical decision making. J Am Coll Cardiol. 2012 Jul 24;60(4):304-11. doi: 10.1016/j.jacc.2012.04.020.
PubMed 22813607
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Protein S100 Beta as a Predictor of the Outcome of Cardiopulmonary Resuscitation
- ClinicalTrials.gov ID
- NCT00814814
- Acronym / sponsor ID
- 14-01-05 A and B (correction)
- Conditions
- Cardiopulmonary Arrest Outcome
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 313 participants (actual)
- Lead sponsor
- Shaare Zedek Medical CenterUniversity, hospital or other
- Study start
- Feb 2008
- Primary completion
- Nov 2021 (estimated)
- Study completion
- Nov 2021 (estimated)
- First posted
- 25 Dec 2008 (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.
Management of cardiac arrest is complicated by the lack of a readily available tool identifying individuals who are likely to be successfully resuscitated. S100 beta is a protein that originates in the astroglial cells of the brain, and NSE (Neuron Specific Enolase) is another protein that originates in the neurons themselves. In the laboratory, the concentration of these proteins correlate with evidence of brain damage after head trauma, stroke and exposure to low levels of oxygen. The concentration of these proteins in the blood of human survivors of cardiopulmonary resuscitation in humans is much higher than in patients who were resuscitated but did not survive. However, it is still unclear whether survivors from cardiopulmonary resuscitation have higher levels of these proteins in their blood if they survive with neurological injury secondary to the arrest and resuscitation.
Hypothesis: In humans, the blood concentrations of protein S100 beta and NSE during and after resuscitation can predict who will die despite cardiopulmonary resuscitation and who will survive with neurological injury secondary to the arrest and resuscitation.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cardiopulmonary arrest | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All victims of non-traumatic out-of hospital cardiopulmonary arrest (defined as the absence of either spontaneous respiration or palpable pulse or both) within the Jerusalem district.
Key inclusion criteria (1 listed)
- All victims of non-traumatic out-of hospital cardiopulmonary arrest (defined as the absence of either spontaneous respiration or palpable pulse or both) within the Jerusalem district.
Key exclusion criteria (2 listed)
- Patients with do-not-resuscitate orders or an advance directive to that effect.
- Patients with intracranial hemorrhage
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
Poor versus good patient outcome at discharge was used to test the study hypotheses of improved prediction attributable to S100B and NSE concentration.
Time frame: within 24 hours of discharge
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Nov 2020.
- Results publication: PubMed 23391666Einav S, Kaufman N, Algur N, Strauss-Liviatan N, Kark JD. Brain biomarkers and management of uncertainty in predicting outcome of cardiopulmonary resuscitation: a nomogram paints a thousand words. Resuscitation. 2013 Aug;84(8):1083-8. doi: 10.1016/j.resuscitation.2013.01.031. Epub 2013 Feb 4.
- Results publication: PubMed 22813607Einav S, Kaufman N, Algur N, Kark JD. Modeling serum biomarkers S100 beta and neuron-specific enolase as predictors of outcome after out-of-hospital cardiac arrest: an aid to clinical decision making. J Am Coll Cardiol. 2012 Jul 24;60(4):304-11. doi: 10.1016/j.jacc.2012.04.020.
- Individual participant dataSharing planned: Yes
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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.
Sharon Einav, MD principal investigator
Shaare Zedek Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiopulmonary Arrest Outcome, run by Shaare Zedek Medical Center at 2 sites in Israel.
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 1 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 16 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Israel. 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?
Results are not available in the source record.
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.
What does the primary outcome measure?
Poor versus good patient outcome at discharge was used to test the study hypotheses of improved prediction attributable to S100B and NSE concentration. (time frame: within 24 hours of discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00814814, which also lists 2 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 16 Nov 2020.