The Complement Lectin Pathway After Cardiac Arrest
Primary Purpose
Out-of-Hospital Cardiac Arrest, Post Cardiac Arrest Syndrome
Status
Unknown status
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Targeted temperature management (33 degree Celsius)
Sponsored by
About this trial
This is an interventional basic science trial for Out-of-Hospital Cardiac Arrest
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
Sites / Locations
- Department of Biomedicine, Aarhus University
- Department of Anesthesiology and Intensive Care, Aarhus University Hospital
- Department of Clinical Biochemistry, Aarhus University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
24 hour of targeted temperature management
48 hour of targeted temperature management
Arm Description
Patients resuscitated after cardiac arrest and treated with 24 hours of targeted temperature management (33 degree Celsius)
Patients resuscitated after cardiac arrest and treated with 48 hours of targeted temperature management (33 degree Celsius)
Outcomes
Primary Outcome Measures
MASP-2 concentration in plasma
Secondary Outcome Measures
MASP-2 concentration in plasma
MASP-2 concentration in plasma
MASP-2 concentration in plasma compared with 30-day mortality
MASP-2 concentration in plasma
MASP-1 concentration in plasma
MASP-1 concentration in plasma
MASP-1 concentration in plasma
MASP-1 concentration in plasma compared with 30-day mortality
MASP-3 concentration in plasma
MASP-3 concentration in plasma
MASP-3 concentration in plasma
MASP-3 concentration in plasma compared with 30-day mortality
Mannan-Binding-Lectin concentration in plasma
Mannan-Binding-Lectin concentration in plasma
Mannan-Binding-Lectin concentration in plasma
Mannan-Binding-Lectin concentration in plasma compared to 30-day mortality
MAp44 concentration in plasma
Map44 concentration in plasma
MAp44 concentration in plasma
MAp44 concentration in plasma compared with 30-day mortality
MAp19 concentration in plasma
MAp19 concentration in plasma
MAp19 concentration in plasma
MAp19 concentration in plasma compared with 30-day mortality
H-ficolin concentration in plasma
H-ficolin concentration in plasma
H-ficolin concentration in plasma
H-ficolin concentration in plasma compared with 30-day mortality
M-ficolin concentration in plasma
M-ficolin concentration in plasma
M-ficolin concentration in plasma
M-ficolin concentration in plasma compared with 30-day mortality
CL-L1 concentration in plasma
CL-L1 concentration in plasma
CL-L1 concentration in plasma
CL-L1 concentration in plasma compared with 30-day mortality
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02826057
Brief Title
The Complement Lectin Pathway After Cardiac Arrest
Official Title
The Complement Lectin Pathway in Patients Resuscitated After Cardiac Arrest
Study Type
Interventional
2. Study Status
Record Verification Date
June 2016
Overall Recruitment Status
Unknown status
Study Start Date
February 2016 (undefined)
Primary Completion Date
July 2016 (Anticipated)
Study Completion Date
July 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Aarhus
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Out-of-Hospital Cardiac Arrest, Post Cardiac Arrest Syndrome
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
82 (Actual)
8. Arms, Groups, and Interventions
Arm Title
24 hour of targeted temperature management
Arm Type
Active Comparator
Arm Description
Patients resuscitated after cardiac arrest and treated with 24 hours of targeted temperature management (33 degree Celsius)
Arm Title
48 hour of targeted temperature management
Arm Type
Experimental
Arm Description
Patients resuscitated after cardiac arrest and treated with 48 hours of targeted temperature management (33 degree Celsius)
Intervention Type
Other
Intervention Name(s)
Targeted temperature management (33 degree Celsius)
Primary Outcome Measure Information:
Title
MASP-2 concentration in plasma
Time Frame
48 hours
Secondary Outcome Measure Information:
Title
MASP-2 concentration in plasma
Time Frame
24 hours, 48 hours and 72 hours
Title
MASP-2 concentration in plasma
Description
MASP-2 concentration in plasma compared with 30-day mortality
Time Frame
24 hours, 48 hours, 72 hours
Title
MASP-2 concentration in plasma
Time Frame
24 hours to 72 hours
Title
MASP-1 concentration in plasma
Time Frame
24 hours, 48 hours and 72 hours
Title
MASP-1 concentration in plasma
Time Frame
24 hours to 72 hours
Title
MASP-1 concentration in plasma
Description
MASP-1 concentration in plasma compared with 30-day mortality
Time Frame
24 hours, 48 hours, 72 hours
Title
MASP-3 concentration in plasma
Time Frame
24 hours, 48 hours and 72 hours
Title
MASP-3 concentration in plasma
Time Frame
24 hours to 72 hours
Title
MASP-3 concentration in plasma
Description
MASP-3 concentration in plasma compared with 30-day mortality
Time Frame
24 hours, 48 hours, 72 hours
Title
Mannan-Binding-Lectin concentration in plasma
Time Frame
24 hours, 48 hours and 72 hours
Title
Mannan-Binding-Lectin concentration in plasma
Time Frame
24 hours to 72 hours
Title
Mannan-Binding-Lectin concentration in plasma
Description
Mannan-Binding-Lectin concentration in plasma compared to 30-day mortality
Time Frame
24 hours, 48 hours, 72 hours
Title
MAp44 concentration in plasma
Time Frame
24 hours, 48 hours and 72 hours
Title
Map44 concentration in plasma
Time Frame
24 hours to 72 hours
Title
MAp44 concentration in plasma
Description
MAp44 concentration in plasma compared with 30-day mortality
Time Frame
24 hours, 48 hours, 72 hours
Title
MAp19 concentration in plasma
Time Frame
24 hours, 48 hours and 72 hours
Title
MAp19 concentration in plasma
Time Frame
24 hours to 72 hours
Title
MAp19 concentration in plasma
Description
MAp19 concentration in plasma compared with 30-day mortality
Time Frame
24 hours, 48 hours, 72 hours
Title
H-ficolin concentration in plasma
Time Frame
24 hours, 48 hours and 72 hours
Title
H-ficolin concentration in plasma
Time Frame
24 hours to 72 hours
Title
H-ficolin concentration in plasma
Description
H-ficolin concentration in plasma compared with 30-day mortality
Time Frame
24 hours, 48 hours, 72 hours
Title
M-ficolin concentration in plasma
Time Frame
24 hours, 48 hours and 72 hours
Title
M-ficolin concentration in plasma
Time Frame
24 hours to 72 hours
Title
M-ficolin concentration in plasma
Description
M-ficolin concentration in plasma compared with 30-day mortality
Time Frame
24 hours, 48 hours, 72 hours
Title
CL-L1 concentration in plasma
Time Frame
24 hours, 48 hours and 72 hours
Title
CL-L1 concentration in plasma
Time Frame
24 hours to 72 hours
Title
CL-L1 concentration in plasma
Description
CL-L1 concentration in plasma compared with 30-day mortality
Time Frame
24 hours, 48 hours, 72 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Department of Biomedicine, Aarhus University
City
Aarhus
ZIP/Postal Code
8000
Country
Denmark
Facility Name
Department of Anesthesiology and Intensive Care, Aarhus University Hospital
City
Aarhus
ZIP/Postal Code
8200
Country
Denmark
Facility Name
Department of Clinical Biochemistry, Aarhus University Hospital
City
Aarhus
ZIP/Postal Code
8200
Country
Denmark
12. IPD Sharing Statement
Learn more about this trial
The Complement Lectin Pathway After Cardiac Arrest
We'll reach out to this number within 24 hrs