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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Matty Koopmans, Medical Centre Leeuwarden
ClinicalTrials.gov Identifier:
NCT01850485
First received: April 23, 2012
Last updated: May 6, 2013
Last verified: May 2013
  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 Medical Centre Leeuwarden:

Primary Outcome Measures:
  • Microvascular Flow Index (MFI) [ Time Frame: difference between timepoint 0, 12 and 24 ] [ Designated as safety issue: No ]
    MFI sublingual (SDF)


Secondary Outcome Measures:
  • RincStO2 (NIRS)= tissue oxygenation [ Time Frame: timepoint 0, 12 and 24 hours ] [ Designated as safety issue: No ]
  • Fluid balance after 24 hours [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
  • Inotropes and vasopressor dose [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
  • Cardiac Index [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
  • Lactate [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
  • SvO2 (venous oxygen saturation) [ Time Frame: 24 hours ] [ Designated as safety issue: No ]

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
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
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Matty Koopmans, RN, Medical Centre Leeuwarden
ClinicalTrials.gov Identifier: NCT01850485     History of Changes
Other Study ID Numbers: TPO 745
Study First Received: April 23, 2012
Last Updated: May 6, 2013
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

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

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

ClinicalTrials.gov processed this record on September 16, 2014