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

U

University of Leipzig

Status

Completed

Conditions

Hypothermia
Cardiac Arrest

Treatments

Device: Coolgard
Device: ArcticSun

Study type

Observational

Funder types

Other

Identifiers

NCT01102153
COOL-NSE

Details and patient eligibility

About

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.

Full 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.

Enrollment

108 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

108 participants in 2 patient groups

Coolgard
Description:
invasive cooling
Treatment:
Device: Coolgard
ArcticSun
Description:
non-invasive (surface) cooling
Treatment:
Device: ArcticSun

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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