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

Completed

• Conditions: Cardiac Arrest
• Interventions: Device: microcirculation by SDF and NIRS, in 33 and 36 degrees

• Registration Number: NCT01850485
• Lead Sponsor: Medical Centre Leeuwarden

Brief Summary

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

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.

Study Timeline

• Study Start: 2012-02
• Study First Submitted: 2012-04-23
• Primary Completion: 2013-01
• Study Completion: 2013-05
• Study First Submitted QC: 2013-05-06
• Study First Posted: 2013-05-09
• Results First Submitted: 2014-12-01
• Status Verified: 2015-06
• Results First Submitted QC: 2015-06-22
• Last Update Submitted: 2015-06-22
• Results First Posted: 2015-06-25
• Last Update Posted: 2015-06-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
33 degrees, therapeutic hypothermia	microcirculation by SDF and NIRS, in 33 and 36 degrees	microcirculation after cardiac arrest by SDF and NIRS, in patients treated with 33 degrees, difference is temperature, in this group 33
normothermia, 36 degrees	microcirculation by SDF and NIRS, in 33 and 36 degrees	microcirculation after cardiac arrest by SDF and NIRS, in patients treated with 36 degrees, difference is temperature, in this group 36

Primary Outcome Measures

Name	Time	Method
Microvascular Flow Index (MFI)	baseline measurement	Microvascular Flow Index; minimum score = 0 (= no flow) and maximum score = 3 (=normal flow)

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Medical Center Leeuwarden; 🇳🇱 Leeuwarden, Netherlands