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

NCT ID: NCT01102153

Last Updated: 2010-04-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

108 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-04-30

Study Completion Date

2010-01-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Cardiac Arrest Hypothermia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Coolgard

invasive cooling

Coolgard

Intervention Type DEVICE

invasive cooling via femoral ICY-catheter

ArcticSun

non-invasive (surface) cooling

ArcticSun

Intervention Type DEVICE

non-invasive surface cooling by saline-cooled thermo-vest

Interventions

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Coolgard

invasive cooling via femoral ICY-catheter

Intervention Type DEVICE

ArcticSun

non-invasive surface cooling by saline-cooled thermo-vest

Intervention Type DEVICE

Other Intervention Names

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CG AS

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Leipzig

OTHER

Sponsor Role lead

Responsible Party

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University of Leipzig, Heart Center

Principal Investigators

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Holger Thiele, Associate Professor

Role: PRINCIPAL_INVESTIGATOR

Study Chair

Undine Pittl, MD

Role: STUDY_DIRECTOR

Study Sub-Investigator

Alexandra Schratter, MD

Role: STUDY_DIRECTOR

Study Sub-Investigator

Locations

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University of Leipzig, Heart Center, Cardiology

Leipzig, , Germany

Site Status

University of Leipzig, Heart Center, Cardiology

Leipzig, , Germany

Site Status

Countries

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Germany

References

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Sulaj M, Saniova B, Drobna E, Schudichova J. Serum neuron specific enolase and malondialdehyde in patients after out-of-hospital cardiac arrest. Cell Mol Neurobiol. 2009 Sep;29(6-7):807-10. doi: 10.1007/s10571-009-9361-y. Epub 2009 Feb 25.

Reference Type BACKGROUND
PMID: 19241153 (View on PubMed)

Shinozaki K, Oda S, Sadahiro T, Nakamura M, Hirayama Y, Abe R, Tateishi Y, Hattori N, Shimada T, Hirasawa H. S-100B and neuron-specific enolase as predictors of neurological outcome in patients after cardiac arrest and return of spontaneous circulation: a systematic review. Crit Care. 2009;13(4):R121. doi: 10.1186/cc7973. Epub 2009 Jul 22.

Reference Type BACKGROUND
PMID: 19624826 (View on PubMed)

Other Identifiers

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COOL-NSE

Identifier Type: -

Identifier Source: org_study_id

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