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

June 22, 2015 updated by: Matty Koopmans, Medical Centre Leeuwarden

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

22

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Netherlands
      • Leeuwarden, Netherlands, 8934 AD
        • Medical Center Leeuwarden

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

patients after out of hospital cardiac arrest

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
normothermia, 36 degrees
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
at baseline, after 12 and 24 hours in both arms
Other Names:
  • measurements of the microcirculation by SDF and NIRS
  • in both arms
33 degrees, therapeutic hypothermia
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
at baseline, after 12 and 24 hours in both arms
Other Names:
  • measurements of the microcirculation by SDF and NIRS
  • in both arms

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Medical Centre Leeuwarden

Investigators

  • Principal Investigator: Matty Koopmans, RN, Medical Center Leeuwarden

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2012

Primary Completion (Actual)

January 1, 2013

Study Completion (Actual)

May 1, 2013

Study Registration Dates

First Submitted

April 23, 2012

First Submitted That Met QC Criteria

May 6, 2013

First Posted (Estimate)

May 9, 2013

Study Record Updates

Last Update Posted (Estimate)

June 25, 2015

Last Update Submitted That Met QC Criteria

June 22, 2015

Last Verified

June 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TPO 745

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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