NCT01531426

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
94

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2012

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 6, 2012

Completed
7 days until next milestone

First Posted

Study publicly available on registry

February 13, 2012

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2013

Completed
Last Updated

February 25, 2013

Status Verified

February 1, 2013

Enrollment Period

1 year

First QC Date

February 6, 2012

Last Update Submit

February 22, 2013

Conditions

Cardiac Arrest

Keywords

resuscitationhypothermiaoutcome

Outcome Measures

Primary Outcomes (1)

  • neurological outcome (death; CPC: 5)

    Cerebral Performance Category 5: death

    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

    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

Study Arms (1)

NIRS continuous monitoring

Device: near infrared spectroscopy (INVOS®, Covidien)

Interventions

near infrared spectroscopy (INVOS®, Covidien)DEVICE

Measurement of regional cerebral oxygen saturation with non-invasive near-infrared INVOS® (In-Vivo Optical Spectroscopy) monitor by Covidien.

Also known as: INVOS® (In-Vivo Optical Spectroscopy), Covidien
NIRS continuous monitoring

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients after cardiac arrest

You may qualify if:

  • over 18 years

You may not qualify if:

  • under 18 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Charité Universitätsmedizin

Berlin, 13353, Germany

Location

MeSH Terms

Conditions

Heart ArrestHypothermia

Interventions

Spectroscopy, Near-Infrared

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesBody Temperature ChangesSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diagnostic ImagingDiagnostic Techniques and ProceduresDiagnosisSpectrum AnalysisChemistry Techniques, AnalyticalInvestigative Techniques

Study Officials

  • Christian Storm, MD

    Charite University, Berlin, Germany

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 6, 2012

First Posted

February 13, 2012

Study Start

January 1, 2012

Primary Completion

January 1, 2013

Study Completion

January 1, 2013

Last Updated

February 25, 2013

Record last verified: 2013-02

Locations

DE(1)