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Completed

NCT Number: NCT01102153

Neuron Specific Enolase (NSE) as Outcome Parameter of Cooling Therapy 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.

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Key information

Conditions

Cardiac Arrest Body Temperature Changes Cardiovascular Diseases Death Death, Sudden Death, Sudden, Cardiac Heart Arrest Heart Diseases Hypothermia Pathologic Processes Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Coolgard

Device

invasive cooling via femoral ICY-catheter

Other names: CG

ArcticSun

Device

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

Other names: AS

Primary outcomes

  1. 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.

Secondary outcomes

  1. neurologic outcome

    Time frame: 6 months

    At 6 months after cardiac arrest, the cerebral performance category score is assessed to determine neurologic outcome.

  2. time to overall survival

    Time frame: one year

    At one year after cardiac arrest, overall survival of the cardiac arrest patients is assessed.

Sponsors and collaborators

Lead sponsor

University of Leipzig

Other

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Apr 13, 2010
Registry last updated
Apr 13, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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