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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01102153

Enrollment

108

Registered

2010-04-13

Start date

2008-04-30

Completion date

2010-01-31

Last updated

2010-04-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiac Arrest, Hypothermia

Keywords

sudden cardiac arrest, Hypothermia, Coolgard, arctic sun, neurological outcome, neuron specific enolase

Brief summary

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.

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.

Interventions

DEVICECoolgard

invasive cooling via femoral ICY-catheter

DEVICEArcticSun

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

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

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

Secondary

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

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026