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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01850485
First Posted: May 9, 2013
Last Update Posted: June 25, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Matty Koopmans, Medical Centre Leeuwarden
  Purpose
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.

Condition Intervention
Cardiac Arrest Device: microcirculation by SDF and NIRS, in 33 and 36 degrees

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Matty Koopmans, Medical Centre Leeuwarden:

Primary Outcome Measures:
  • Microvascular Flow Index (MFI) [ Time Frame: baseline measurement ]
    Microvascular Flow Index; minimum score = 0 (= no flow) and maximum score = 3 (=normal flow)


Secondary Outcome Measures:
  • RincStO2 [ Time Frame: baseline ]
    tissue oxygenation measured by Near Infrared Spectroscopy

  • Fluid Balance After 24 Hours [ Time Frame: 24 hours ]
  • Inotropes and Vasopressor Dose [ Time Frame: baseline ]
  • Cardiac Index [ Time Frame: 24 hours ]
    Cardiac Index is cardiac output indexed for body weight

  • Lactate [ Time Frame: 24 hours ]
    lactate levels in serum

  • SvO2 [ Time Frame: 24 hours ]
    (venous oxygen saturation)


Enrollment: 22
Study Start Date: February 2012
Study Completion Date: May 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
patients after out of hospital cardiac arrest
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01850485


Locations
Netherlands
Medical Center Leeuwarden
Leeuwarden, Netherlands, 8934 AD
Sponsors and Collaborators
Medical Centre Leeuwarden
Investigators
Principal Investigator: Matty Koopmans, RN Medical Center Leeuwarden
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Matty Koopmans, RN, Medical Centre Leeuwarden
ClinicalTrials.gov Identifier: NCT01850485     History of Changes
Other Study ID Numbers: TPO 745
First Submitted: April 23, 2012
First Posted: May 9, 2013
Results First Submitted: December 1, 2014
Results First Posted: June 25, 2015
Last Update Posted: June 25, 2015
Last Verified: June 2015

Keywords provided by Matty Koopmans, Medical Centre Leeuwarden:
cardiac arrest
therapeutic hypothermia
microcirculation

Additional relevant MeSH terms:
Heart Arrest
Out-of-Hospital Cardiac Arrest
Heart Diseases
Cardiovascular Diseases