Clinical trial NCT01102153: Neuron Specific Enolase (NSE) as Outcome Parameter of Cooling Therapy After Survived Sudden Cardiac Death
Official title: NSE as an Outcome Predictor of Therapeutical Hypothermia After Survived Sudden Cardiac Death
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiac Arrest
Hypothermia
Keywords: sudden cardiac arrest
Hypothermia
Coolgard
arctic sun
neurological outcome
neuron specific enolase
Lead sponsor: University of Leipzig
Sponsor class: OTHER
First posted: 2010-04-13
Enrollment: 108
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients who survived sudden cardiac arrest and where treated with cooling-therapies

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.

Eligibility criteria: 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

Primary outcomes:
measure: neuron specific enolase (NSE) as a parameter for cerebral damage
timeFrame: 72 hours
Secondary outcomes:
measure: neurologic outcome
timeFrame: 6 months
measure: time to overall survival
timeFrame: one year
Other outcomes:
Locations:
city: Leipzig
country: Germany
facility: University of Leipzig, Heart Center, Cardiology
city: Leipzig
country: Germany
facility: University of Leipzig, Heart Center, Cardiology
Study officials:
affiliation: Study Chair
name: Holger Thiele, Associate Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: Study Sub-Investigator
name: Undine Pittl, MD
role: STUDY_DIRECTOR
affiliation: Study Sub-Investigator
name: Alexandra Schratter, MD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.