Cardiac ArrestCoCaHYpNCT01531426
Cerebral Oxygenation in Cardiac Arrest and Hypothermia
An observational study of Cardiac Arrest, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial summary
Data indicate that neurological prognostication is difficult after cardiac arrest if mild therapeutic hypothermia is part of the post resuscitation care. Cerebral oxygenation detected by near-infrared spectroscopy, could be a new, non-invasive index marker for outcome assessment after cardiac arrest. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Arrest
- What is being tested?
- near infrared spectroscopy (INVOS®, Covidien)
- Type of treatment
- Medical device
- How many people
- 94 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2012to Jan 2013
- 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: Patients after cardiac arrest
Who may be able to join
- over 18 years
Who cannot join
- under 18 years
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Cerebral Oxygen Saturation as Outcome Predictor in Cardiac Arrest Patients Undergoing Mild Therapeutic Hypothermia
Data indicate that neurological prognostication is difficult after cardiac arrest if mild therapeutic hypothermia is part of the post resuscitation care. Cerebral oxygenation detected by near-infrared spectroscopy, could be a new, non-invasive index marker for outcome assessment after cardiac arrest. The investigators hypothesize that cardiac arrest survivors with a continuously low cerebral oxygenation index have a poor prognosis.
Read the detailed description
The measurement of cerebral oxygen saturation by a non-invasive near-infrared monitor, INVOS® (In-Vivo Optical Spectroscopy; Covidien) can detect changes in oxygen levels reflecting regional blood oxygen saturation of the brain tissue beneath the sensor. If this monitoring can add further information towards reliable prognostication after cardiac arrest is unknown so far.
- Conditions
- Cardiac Arrest
- Being tested
- near infrared spectroscopy (INVOS®, Covidien)
- Keywords
- resuscitation, hypothermia, outcome
- Medical subject headings
- Heart Arrest, Hypothermia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
near infrared spectroscopy (INVOS®, Covidien)Device
Also called INVOS® (In-Vivo Optical Spectroscopy), Covidien
Measurement of regional cerebral oxygen saturation with non-invasive near-infrared INVOS® (In-Vivo Optical Spectroscopy) monitor by Covidien.
| Study group | Role | What they receive |
|---|---|---|
| NIRS continuous monitoring | Not described Receives: Device: near infrared spectroscopy (INVOS®, Covidien) |
What is being measured
The primary outcome is the main question the study is designed to answer.
neurological outcome (death; CPC: 5)
Cerebral Performance Category 5: death
Measured: participants will be followed for the duration of hospital stay, an expected average of 3-6 weeks
Secondary outcomes (1)
neurological outcome CPC 1-5
CPC 1: Conscious and alert with normal function or only slight disability CPC 2: Conscious and alert with moderate disability CPC 3: Conscious with severe disability CPC 4: Comatose or persistent vegetative state CPC 5: death
Measured: participants will be followed for the duration of hospital stay, an expected average of 3-6 weeks and a 12 month follow up will be performed
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2012 (estimated)
- Study startJan 2012
- Primary completionJan 2013
- Study completionJan 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac ArrestStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Collaborators
- Medtronic - MITG
- Responsible party
- Principal investigator, C. Storm, Charite University, Berlin, Germany
- Investigators
- Christian Storm, MD, Principal investigator, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01531426
- Sponsor's protocol ID
- CoCa-01-12
- Acronym
- CoCaHYp
- Status last verified
- Feb 2013
- First submitted
- 6 Feb 2012
- Last updated
- 25 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cerebral Oxygen Saturation as Outcome Predictor in Cardiac Arrest Patients Undergoing Mild Therapeutic Hypothermia
- ClinicalTrials.gov ID
- NCT01531426
- Acronym / sponsor ID
- CoCaHYp / CoCa-01-12
- Conditions
- Cardiac Arrest
- Keywords
- resuscitation, hypothermia, outcome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Collaborators
- Medtronic - MITG
- Study start
- Jan 2012
- Primary completion
- Jan 2013 (actual)
- Study completion
- Jan 2013 (actual)
- First posted
- 13 Feb 2012 (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.
Data indicate that neurological prognostication is difficult after cardiac arrest if mild therapeutic hypothermia is part of the post resuscitation care. Cerebral oxygenation detected by near-infrared spectroscopy, could be a new, non-invasive index marker for outcome assessment after cardiac arrest. The investigators hypothesize that cardiac arrest survivors with a continuously low cerebral oxygenation index have a poor prognosis.
Detailed description
The measurement of cerebral oxygen saturation by a non-invasive near-infrared monitor, INVOS® (In-Vivo Optical Spectroscopy; Covidien) can detect changes in oxygen levels reflecting regional blood oxygen saturation of the brain tissue beneath the sensor. If this monitoring can add further information towards reliable prognostication after cardiac arrest is unknown so far.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| NIRS continuous monitoring | – | Device: near infrared spectroscopy (INVOS®, Covidien) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients after cardiac arrest
Key inclusion criteria (1 listed)
- over 18 years
Key exclusion criteria (1 listed)
- under 18 years
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| near infrared spectroscopy (INVOS®, Covidien)Also: INVOS® (In-Vivo Optical Spectroscopy), CovidienMeasurement of regional cerebral oxygen saturation with non-invasive near-infrared INVOS® (In-Vivo Optical Spectroscopy) monitor by Covidien. | Device | NIRS continuous monitoring |
Primary outcome
neurological outcome (death; CPC: 5)
Time frame: participants will be followed for the duration of hospital stay, an expected average of 3-6 weeks
Cerebral Performance Category 5: death
1 secondary outcome
neurological outcome CPC 1-5
Time frame: participants will be followed for the duration of hospital stay, an expected average of 3-6 weeks and a 12 month follow up will be performed
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Feb 2013.
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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.
Christian Storm, MD principal investigator
Charite University, Berlin, Germany
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, run by Charite University, Berlin, Germany at 1 site in Germany.
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 1 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: finished, as of the sponsor's last update on 25 Feb 2013. 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 Germany. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
neurological outcome (death; CPC: 5) (time frame: participants will be followed for the duration of hospital stay, an expected average of 3-6 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Feb 2013.