The Complement Lectin Pathway After Cardiac Arrest

Not Applicable

• Conditions: Post Cardiac Arrest Syndrome; Out-of-Hospital Cardiac Arrest
• Interventions: Other: Targeted temperature management (33 degree Celsius)

• Registration Number: NCT02826057
• Lead Sponsor: University of Aarhus

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-02
• Status Verified: 2016-06
• Study First Submitted: 2016-06-16
• Primary Completion: 2016-07
• Study First Submitted QC: 2016-07-04
• Last Update Submitted: 2016-07-04
• Study First Posted: 2016-07-07
• Last Update Posted: 2016-07-07
• Study Completion: 2017-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 82

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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
24 hour of targeted temperature management	Targeted temperature management (33 degree Celsius)	Patients resuscitated after cardiac arrest and treated with 24 hours of targeted temperature management (33 degree Celsius)
48 hour of targeted temperature management	Targeted temperature management (33 degree Celsius)	Patients resuscitated after cardiac arrest and treated with 48 hours of targeted temperature management (33 degree Celsius)

Primary Outcome Measures

Name	Time	Method
MASP-2 concentration in plasma	48 hours

Secondary Outcome Measures

Name	Time	Method
Mannan-Binding-Lectin concentration in plasma	24 hours, 48 hours, 72 hours	Mannan-Binding-Lectin concentration in plasma compared to 30-day mortality
MASP-2 concentration in plasma	24 hours to 72 hours
MASP-1 concentration in plasma	24 hours, 48 hours, 72 hours	MASP-1 concentration in plasma compared with 30-day mortality
MASP-3 concentration in plasma	24 hours, 48 hours, 72 hours	MASP-3 concentration in plasma compared with 30-day mortality
MAp44 concentration in plasma	24 hours, 48 hours, 72 hours	MAp44 concentration in plasma compared with 30-day mortality
Map44 concentration in plasma	24 hours to 72 hours
MAp19 concentration in plasma	24 hours, 48 hours, 72 hours	MAp19 concentration in plasma compared with 30-day mortality
H-ficolin concentration in plasma	24 hours, 48 hours, 72 hours	H-ficolin concentration in plasma compared with 30-day mortality
M-ficolin concentration in plasma	24 hours, 48 hours, 72 hours	M-ficolin concentration in plasma compared with 30-day mortality
CL-L1 concentration in plasma	24 hours, 48 hours, 72 hours	CL-L1 concentration in plasma compared with 30-day mortality

Trial Locations

Locations (3)

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