NCT01083069

Brief Summary

Sudden cardiac arrest (SCA) remains one of the major leading causes of death. Cognitive deficits are common in survivors of SCA. Postresuscitative mild induced hypothermia (MIH) lowers mortality and reduces neurologic damage after cardiac arrest. The investigators evaluated the long term neurological outcome after mild hypothermia after restoration of spontaneous circulation.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2010

Geographic Reach
1 country

1 active site

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 25, 2010

Completed
12 days until next milestone

First Posted

Study publicly available on registry

March 9, 2010

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2010

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2011

Completed
Last Updated

March 9, 2010

Status Verified

January 1, 2010

Enrollment Period

11 months

First QC Date

February 25, 2010

Last Update Submit

March 8, 2010

Conditions

Cardiac ArrestHypothermia

Keywords

Sudden cardiac arresthypothermianeurological outcome

Outcome Measures

Primary Outcomes (1)

  • Neurological outcome after 6 month after MIH, Quality of life-survey

    Neurological outcome after 6 month after MIH measured by questionnaire.

    6 Month

Secondary Outcomes (4)

  • Managing daily activities

    6 Month

  • Surviving after hospitalization

    6 Month

  • Neurological outcome depending of the beginning of MIH

    6 month

  • Neurological Outcome in consideration of the practice of the treating instances.

    6 month

Study Arms (2)

COOL

Patients after therapy with mild hypothermia

UnCool

Patients without therapy with mild hypothermia due to non-operational cooling-devices

Eligibility Criteria

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

Patients after restoration of spontaneous circulation

You may qualify if:

  • survived cardiac arrest
  • voluntary consent

You may not qualify if:

  • no voluntary consent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Leipzig, Heart Center, Cardiology

Leipzig, Germany

RECRUITING

MeSH Terms

Conditions

Heart ArrestHypothermiaDeath, Sudden, Cardiac

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesBody Temperature ChangesSigns and SymptomsPathological Conditions, Signs and SymptomsDeath, SuddenDeathPathologic Processes

Study Officials

  • Holger Thiele, Associate Professor

    Study Chair

    PRINCIPAL INVESTIGATOR

  • Undine Pittl, MD

    Study Sub-invesigator

    STUDY DIRECTOR

Central Study Contacts

Undine Pittl, MD

CONTACT

0049-341-8651427undine.pittl@gmail.com

Holger Thiele, Associate Professor

CONTACT

0049-341-8651427thielh@med.uni-leipzig.de

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 25, 2010

First Posted

March 9, 2010

Study Start

January 1, 2010

Primary Completion

December 1, 2010

Study Completion

June 1, 2011

Last Updated

March 9, 2010

Record last verified: 2010-01

Locations

DE(1)