Neuron Specific Enolase (NSE) as Outcome Parameter of Cooling Therapy After Survived Sudden Cardiac Death

April 12, 2010 updated by: University of Leipzig

NSE as an Outcome Predictor of Therapeutical Hypothermia After Survived Sudden Cardiac Death

Sudden cardiac death remains one of the major leading causes of death. Therapeutic hypothermia is a validated standard procedure to avoid or minimize cognitive deficits after cardiac arrest. To assess the efficiency of different cooling methods and further improve these methods, the investigators collected blood samples to measure the neuron specific enolase (NSE) in patients treated with invasive cooling as compared to patients treated with non-invasive cooling.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Consecutive patients with restoration of spontaneous circulation after resuscitation due to sudden cardiac death were randomized to either non-invasive or invasive cooling for at least 24 hours. NSE was collected at designated time points and compared between patients treated with invasive cooling and those treated with non-invasive cooling. Neurological outcome was assessed between groups at hospital discharge and 6 months after discharge.

Study Type

Observational

Enrollment (Actual)

108

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Leipzig, Germany, 04289
        • University of Leipzig, Heart Center, Cardiology
      • Leipzig, Germany
        • University of Leipzig, Heart Center, Cardiology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients who survived sudden cardiac arrest and where treated with cooling-therapies

Description

Inclusion Criteria:

  • ROSC after sudden cardiac death (SCA) due to VF/VT or PEA/Asystolia
  • GCS 3

Exclusion Criteria:

  • Non-cardiac sudden death
  • Pregnancy
  • Unstable circulation with high-dose inotropics
  • Life-expectancy reducing concomitant illness

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Coolgard
invasive cooling
Device: Coolgard
invasive cooling via femoral ICY-catheter
Other Names:
  • CG
ArcticSun
non-invasive (surface) cooling
Device: ArcticSun
non-invasive surface cooling by saline-cooled thermo-vest
Other Names:
  • AS

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
neuron specific enolase (NSE) as a parameter for cerebral damage
Time Frame: 72 hours
Blood samples were collected at predefined time-points within 72 hours to measure neuron specific enolase.
72 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
neurologic outcome
Time Frame: 6 months
At 6 months after cardiac arrest, the cerebral performance category score is assessed to determine neurologic outcome.
6 months
time to overall survival
Time Frame: one year
At one year after cardiac arrest, overall survival of the cardiac arrest patients is assessed.
one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Leipzig

Investigators

  • Principal Investigator: Holger Thiele, Associate Professor, Study Chair
  • Study Director: Undine Pittl, MD, Study Sub-Investigator
  • Study Director: Alexandra Schratter, MD, Study Sub-Investigator

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2008

Primary Completion (Actual)

January 1, 2010

Study Completion (Actual)

January 1, 2010

Study Registration Dates

First Submitted

February 8, 2010

First Submitted That Met QC Criteria

April 12, 2010

First Posted (Estimate)

April 13, 2010

Study Record Updates

Last Update Posted (Estimate)

April 13, 2010

Last Update Submitted That Met QC Criteria

April 12, 2010

Last Verified

January 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • COOL-NSE

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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