Microcirculatory Perfusion in Patients With Coma After Out-of-hospital Cardiac Arrest

Study Overview
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Brief Summary
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The hypothesis is: In patients after an out of hospital cardiac arrest, treated with therapeutic hypothermia (33°C) will be found significantly more microcirculatory abnormalities, compared to the same group of patients treated with 36°C.

Detailed Description
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The purpose of this study is to investigate the (sublingual) microcirculation in patients after an out of hospital cardiac arrest (OHCA). The microcirculation is measured in this study by Sublingual Side Stream Darkfield (SDF) Imaging and Near InfraRed Spectroscopy (NIRS) at admission and after 12 and 24 hours.

Official Title
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Microcirculatory Perfusion as Measured by Sublingual SDF Imaging and NIRS in Patients With Coma After Out-of-hospital Cardiac Arrest Treated With Mild Therapeutic Hypothermia (TH) or Not Treated With Mild-TH

Conditions
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Cardiac Arrest

Intervention / Treatment
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* Device: microcirculation by SDF and NIRS, in 33 and 36 degrees


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: out-of-hospital cardiac arrest > 18 years informed consent ROSC (return of spontaneous circulation) < 4 hours Exclusion Criteria: recent maxillofacial surgery participation in other clinical trials

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| normothermia, 36 degrees<br>microcirculation after cardiac arrest by SDF and NIRS, in patients treated with 36 degrees, difference is temperature, in this group 36 | Device: microcirculation by SDF and NIRS, in 33 and 36 degrees<br>* at baseline, after 12 and 24 hours in both arms<br>* Other names: in both arms;|
| 33 degrees, therapeutic hypothermia<br>microcirculation after cardiac arrest by SDF and NIRS, in patients treated with 33 degrees, difference is temperature, in this group 33 | Device: microcirculation by SDF and NIRS, in 33 and 36 degrees<br>* at baseline, after 12 and 24 hours in both arms<br>* Other names: in both arms;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Microvascular Flow Index (MFI) | Microvascular Flow Index; minimum score = 0 (= no flow) and maximum score = 3 (=normal flow) | baseline measurement | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| RincStO2 | tissue oxygenation measured by Near Infrared Spectroscopy | baseline | 
| Fluid Balance After 24 Hours |  | 24 hours | 
| Inotropes and Vasopressor Dose |  | baseline | 
| Cardiac Index | Cardiac Index is cardiac output indexed for body weight | 24 hours | 
| Lactate | lactate levels in serum | 24 hours | 
| SvO2 | (venous oxygen saturation) | 24 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cardiac arrest, therapeutic hypothermia, microcirculation