Cerebral Oxygenation in Cardiac Arrest and Hypothermia (CoCaHYp)
This study has been completed.
Sponsor:
Charite University, Berlin, Germany
Collaborator:
Covidien
Information provided by (Responsible Party):
C. Storm, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:
NCT01531426
First received: February 6, 2012
Last updated: February 22, 2013
Last verified: February 2013
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | February 6, 2012 | ||||
| Last Updated Date | February 22, 2013 | ||||
| Start Date ICMJE | January 2012 | ||||
| Primary Completion Date | January 2013 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
neurological outcome (death; CPC: 5) [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 3-6 weeks ] [ Designated as safety issue: No ] Cerebral Performance Category 5: death |
||||
| Original Primary Outcome Measures ICMJE |
neurological outcome (death; CPC: 5) [ Time Frame: participants will be followed for the duration of hospital stay, an expected average of 3-6 weeks ] [ Designated as safety issue: No ] Cerebral Performance Categorie 5: death |
||||
| Change History | Complete list of historical versions of study NCT01531426 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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 ] [ Designated as safety issue: No ] 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 |
||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Cerebral Oxygenation in Cardiac Arrest and Hypothermia | ||||
| Official Title ICMJE | Cerebral Oxygen Saturation as Outcome Predictor in Cardiac Arrest Patients Undergoing Mild Therapeutic Hypothermia | ||||
| Brief 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. 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 Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
||||
| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | Patients after cardiac arrest |
||||
| Condition ICMJE | Cardiac Arrest | ||||
| Intervention ICMJE | Device: near infrared spectroscopy (INVOS®, Covidien)
Measurement of regional cerebral oxygen saturation with non-invasive near-infrared INVOS® (In-Vivo Optical Spectroscopy) monitor by Covidien.
Other Names:
|
||||
| Study Group/Cohort (s) | NIRS continuous monitoring
Intervention: Device: near infrared spectroscopy (INVOS®, Covidien) |
||||
| Publications * | Not Provided | ||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||
| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 94 | ||||
| Completion Date | January 2013 | ||||
| Primary Completion Date | January 2013 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
||||
| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Germany | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01531426 | ||||
| Other Study ID Numbers ICMJE | CoCa-01-12 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | C. Storm, Charite University, Berlin, Germany | ||||
| Study Sponsor ICMJE | Charite University, Berlin, Germany | ||||
| Collaborators ICMJE | Covidien | ||||
| Investigators ICMJE |
|
||||
| Information Provided By | Charite University, Berlin, Germany | ||||
| Verification Date | February 2013 | ||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||