Histones and Free-plasma DNA After Cardiac Arrest

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

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

Study Overview

• Status: Completed
• Conditions: Heart Arrest; Hypothermia; Post Cardiac Arrest Syndrome
• Intervention / Treatment: Other: cardiac arrest

• Study Type: Observational
• Enrollment (Actual): 42

Contacts and Locations

Study Locations

• Denmark
  • Aarhus N
    • Aarhus, Aarhus N, Denmark, 8200
      • Dept of Anesthesiology and Intensive Care and Dept of Clinical Biochemistry, Aarhus University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Cardiac arrest patients with a presumed cardiac origin, treated with targeted temperature management for 24 hours.

For comparison; 20 healthy individuals were used.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
cardiac arrest patients; Patients who has suffered a cardiac arrest	Other: cardiac arrest

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Plasma histones	The level of plasma histones	Approximate 24 hours after cardiac arrest
Free-plasma DNA	The level of total free-plasma DNA	Approximate 24 hours after cardiac arrest

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Plasma histones	The level of plasma histones	Approximate 48 hours and 72 hours after cardiac arrest
Free-plasma DNA	The level of total free plasma DNA	Approximate 48 hours and 72 hours after cardiac arrest

Other Outcome Measures

Outcome Measure	Time Frame
Simplified Acute Physiology Score (SAPS) score	Approximate 24 hours, 48 hours and 72 hours after cardiac arrest
Platelet count	Approximate 24 hours, 48 hours and 72 hours after cardiac arrest

Collaborators and Investigators

• Sponsor: University of Aarhus

Study record dates

Study Major Dates

• Study Start: October 1, 2015
• Primary Completion (ACTUAL): June 1, 2016
• Study Completion (ACTUAL): September 1, 2016

Study Registration Dates

• First Submitted: March 30, 2016
• First Submitted That Met QC Criteria: April 4, 2016
• First Posted (ESTIMATE): April 11, 2016

Study Record Updates

• Last Update Posted (ACTUAL): June 2, 2017
• Last Update Submitted That Met QC Criteria: June 1, 2017
• Last Verified: June 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Postoperative Complications; Body Temperature Changes; Brain Injuries; Reperfusion Injury; Heart Arrest; Hypothermia; Post-Cardiac Arrest Syndrome
• Other Study ID Numbers: AU170878

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO