Histones and Free-plasma DNA After Cardiac Arrest

Hypothermia Clinical Trial

Official title:

Histones and Free-plasma DNA in the Days Following the Cardiac Arrest

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02733146
• Other study ID #: AU170878
• Status: Completed
• Phase: N/A
• First received: March 30, 2016
• Last updated: June 1, 2017
• Start date: October 2015
• Est. completion date: September 2016

Study information

• Verified date: June 2017
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

To evaluate the significance of free-plasma deoxyribonucleic acid (DNA) and plasma histones in cardiac arrest patients.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: September 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Out of hospital cardiac arrest of presumed cardiac cause

• Return of spontaneous circulation (ROSC)

• Glasgow Coma Score < 8

• Age > 18 years and < 80 years

Exclusion Criteria:

• >60 minutes from the circulatory collapse to ROSC

• Time interval > 4 hours from cardiac arrest to initiation of targeted temperature management

• Terminal illness

• Coagulation disorder

• Unwitnessed asystolia

• Cerebral performance category 3-4 before the cardiac arrest

• Severe persistent cardiogenic shock

• Pregnancy

• Persistent cardiogenic shock (systolic blood pressure < 80 despite inotropic treatment)

• New apoplexy or intracerebral hemorrhage

• Lack of consent from the relatives

• Lack of consent from the general practitioner

• Lack of consent from the patient if he/she wakes up and is relevant

Related Conditions & MeSH terms

• Heart Arrest
• Hypothermia
• Post Cardiac Arrest Syndrome

Intervention

Other:
• cardiac arrest

Locations

Country	Name	City	State
Denmark	Dept of Anesthesiology and Intensive Care and Dept of Clinical Biochemistry, Aarhus University Hospital	Aarhus	Aarhus N

Sponsors (1)

Lead Sponsor	Collaborator
University of Aarhus

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Simplified Acute Physiology Score (SAPS) score		Approximate 24 hours, 48 hours and 72 hours after cardiac arrest
Other	Platelet count		Approximate 24 hours, 48 hours and 72 hours after cardiac arrest
Primary	Plasma histones	The level of plasma histones	Approximate 24 hours after cardiac arrest
Primary	Free-plasma DNA	The level of total free-plasma DNA	Approximate 24 hours after cardiac arrest
Secondary	Plasma histones	The level of plasma histones	Approximate 48 hours and 72 hours after cardiac arrest
Secondary	Free-plasma DNA	The level of total free plasma DNA	Approximate 48 hours and 72 hours after cardiac arrest