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

Cardiac Arrest Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01102153
• Other study ID #: COOL-NSE
• Status: Completed
• Phase: Phase 4
• First received: February 8, 2010
• Last updated: April 12, 2010
• Start date: April 2008
• Est. completion date: January 2010

Study information

• Verified date: January 2010
• Source: University of Leipzig
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ministry of Health
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 108
• Est. completion date: January 2010
• Est. primary completion date: January 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cardiac Arrest
• Death, Sudden, Cardiac
• Heart Arrest
• Hypothermia

Intervention

Device:
• Coolgard
invasive cooling via femoral ICY-catheter
• ArcticSun
non-invasive surface cooling by saline-cooled thermo-vest

Locations

Country	Name	City	State
Germany	University of Leipzig, Heart Center, Cardiology	Leipzig
Germany	University of Leipzig, Heart Center, Cardiology	Leipzig

Sponsors (1)

Lead Sponsor	Collaborator
University of Leipzig

Country where clinical trial is conducted

Germany, 

References & Publications (2)

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. Review. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	neuron specific enolase (NSE) as a parameter for cerebral damage	Blood samples were collected at predefined time-points within 72 hours to measure neuron specific enolase.	72 hours	No
Secondary	neurologic outcome	At 6 months after cardiac arrest, the cerebral performance category score is assessed to determine neurologic outcome.	6 months	No
Secondary	time to overall survival	At one year after cardiac arrest, overall survival of the cardiac arrest patients is assessed.	one year	No