Clinical trial NCT02826057: The Complement Lectin Pathway After Cardiac Arrest
Official title: The Complement Lectin Pathway in Patients Resuscitated After Cardiac Arrest
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Out-of-Hospital Cardiac Arrest
Post Cardiac Arrest Syndrome
Lead sponsor: University of Aarhus
Sponsor class: OTHER
First posted: 2016-07-07
Enrollment: 82
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.


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

Primary outcomes:
measure: MASP-2 concentration in plasma
timeFrame: 48 hours
Secondary outcomes:
measure: MASP-2 concentration in plasma
timeFrame: 24 hours, 48 hours and 72 hours
measure: MASP-2 concentration in plasma
timeFrame: 24 hours, 48 hours, 72 hours
measure: MASP-2 concentration in plasma
timeFrame: 24 hours to 72 hours
measure: MASP-1 concentration in plasma
timeFrame: 24 hours, 48 hours and 72 hours
measure: MASP-1 concentration in plasma
timeFrame: 24 hours to 72 hours
measure: MASP-1 concentration in plasma
timeFrame: 24 hours, 48 hours, 72 hours
measure: MASP-3 concentration in plasma
timeFrame: 24 hours, 48 hours and 72 hours
measure: MASP-3 concentration in plasma
timeFrame: 24 hours to 72 hours
measure: MASP-3 concentration in plasma
timeFrame: 24 hours, 48 hours, 72 hours
measure: Mannan-Binding-Lectin concentration in plasma
timeFrame: 24 hours, 48 hours and 72 hours
measure: Mannan-Binding-Lectin concentration in plasma
timeFrame: 24 hours to 72 hours
measure: Mannan-Binding-Lectin concentration in plasma
timeFrame: 24 hours, 48 hours, 72 hours
measure: MAp44 concentration in plasma
timeFrame: 24 hours, 48 hours and 72 hours
measure: Map44 concentration in plasma
timeFrame: 24 hours to 72 hours
measure: MAp44 concentration in plasma
timeFrame: 24 hours, 48 hours, 72 hours
measure: MAp19 concentration in plasma
timeFrame: 24 hours, 48 hours and 72 hours
measure: MAp19 concentration in plasma
timeFrame: 24 hours to 72 hours
measure: MAp19 concentration in plasma
timeFrame: 24 hours, 48 hours, 72 hours
measure: H-ficolin concentration in plasma
timeFrame: 24 hours, 48 hours and 72 hours
measure: H-ficolin concentration in plasma
timeFrame: 24 hours to 72 hours
measure: H-ficolin concentration in plasma
timeFrame: 24 hours, 48 hours, 72 hours
measure: M-ficolin concentration in plasma
timeFrame: 24 hours, 48 hours and 72 hours
measure: M-ficolin concentration in plasma
timeFrame: 24 hours to 72 hours
measure: M-ficolin concentration in plasma
timeFrame: 24 hours, 48 hours, 72 hours
measure: CL-L1 concentration in plasma
timeFrame: 24 hours, 48 hours and 72 hours
measure: CL-L1 concentration in plasma
timeFrame: 24 hours to 72 hours
measure: CL-L1 concentration in plasma
timeFrame: 24 hours, 48 hours, 72 hours
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Department of Biomedicine, Aarhus University
city: Aarhus
country: Denmark
facility: Department of Anesthesiology and Intensive Care, Aarhus University Hospital
city: Aarhus
country: Denmark
facility: Department of Clinical Biochemistry, Aarhus University Hospital
Study officials:
References: