The Complement Lectin Pathway After Cardiac Arrest

NCT ID: NCT02826057

Last Updated: 2016-07-07

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 82 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-02-29
• Study Completion Date: 2017-07-31

Brief Summary

This study includes comatose survivors of out-of-hospital cardiac arrest treated with 24 hours or 48 hours of targeted temperature management.

The overall aim is to evaluate the importance of plasma complement protein concentrations in patients resuscitated after out-of-hospital cardiac arrest and treated with 24 hours or 48 hours of targeted temperature management.

The specific aim is to evaluate:

• the concentration of plasma lectin pathway proteins the first, second and third day after cardiac arrest
• the relation between concentration of plasma lectin pathway proteins and mortality
• if prolonged targeted temperature management influences the concentration of plasma lectin pathway proteins

This study is a sub-study to the trial entitled: "Time-differentiated targeted temperature management (TTH48) (ClinicalTrials.gov Identifier: NCT01689077)"

The following Complement Lectin Pathway proteins will be measured: Mannan-Binding-Lectin, M-ficolin, H-ficolin, CL-L1, MASP-1, MASP-2, MASP-3, MAp19 and MAp44.

Conditions

Out-of-Hospital Cardiac Arrest; Post Cardiac Arrest Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: SINGLE

Study Groups

24 hour of targeted temperature management

Patients resuscitated after cardiac arrest and treated with 24 hours of targeted temperature management (33 degree Celsius)

Group Type: ACTIVE_COMPARATOR

Targeted temperature management (33 degree Celsius)

Intervention Type: OTHER

48 hour of targeted temperature management

Patients resuscitated after cardiac arrest and treated with 48 hours of targeted temperature management (33 degree Celsius)

Group Type: EXPERIMENTAL

Targeted temperature management (33 degree Celsius)

Intervention Type: OTHER

Interventions

Targeted temperature management (33 degree Celsius)

Intervention Type: OTHER

Eligibility Criteria

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 bloodpressure < 80 despite inotropic treatment)
• New apoplexy or cerebral hemorrhage
• Lack of consent from the relatives
• Lack of consent from the general practitioner
• Lack of consent from the patient

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Aarhus

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Department of Biomedicine, Aarhus University

Aarhus, , Denmark

Department of Anesthesiology and Intensive Care, Aarhus University Hospital

Aarhus, , Denmark

Department of Clinical Biochemistry, Aarhus University Hospital

Aarhus, , Denmark

Countries

Denmark

Other Identifiers

12345

Identifier Type: -

Identifier Source: org_study_id