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

Completed

• Conditions: Hypothermia; Cardiac Arrest
• Interventions: Device: ArcticSun; Device: Coolgard

• Registration Number: NCT01102153
• Lead Sponsor: University of Leipzig

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.

Study Timeline

• Study Start: 2008-04
• Status Verified: 2010-01
• Primary Completion: 2010-01
• Study Completion: 2010-01
• Study First Submitted: 2010-02-08
• Study First Submitted QC: 2010-04-12
• Last Update Submitted: 2010-04-12
• Study First Posted: 2010-04-13
• Last Update Posted: 2010-04-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 108

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
ArcticSun	ArcticSun	non-invasive (surface) cooling
Coolgard	Coolgard	invasive cooling

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

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

Trial Locations

Locations (1)

University of Leipzig, Heart Center, Cardiology; 🇩🇪 Leipzig, Germany