Microcirculatory Perfusion in Patients With Coma After Out-of-hospital Cardiac Arrest
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
1 other identifier
observational
22
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Feb 2012
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2012
CompletedFirst Submitted
Initial submission to the registry
April 23, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2013
CompletedFirst Posted
Study publicly available on registry
May 9, 2013
CompletedResults Posted
Study results publicly available
June 25, 2015
CompletedJune 25, 2015
June 1, 2015
11 months
April 23, 2012
December 1, 2014
June 22, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Microvascular Flow Index (MFI)
Microvascular Flow Index; minimum score = 0 (= no flow) and maximum score = 3 (=normal flow)
baseline measurement
Secondary Outcomes (6)
RincStO2
baseline
Fluid Balance After 24 Hours
24 hours
Inotropes and Vasopressor Dose
baseline
Cardiac Index
24 hours
Lactate
24 hours
- +1 more secondary outcomes
Study Arms (2)
normothermia, 36 degrees
microcirculation after cardiac arrest by SDF and NIRS, in patients treated with 36 degrees, difference is temperature, in this group 36
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
Interventions
at baseline, after 12 and 24 hours in both arms
Eligibility Criteria
patients after out of hospital cardiac arrest
You may qualify if:
- out-of-hospital cardiac arrest
- \> 18 years
- informed consent
- ROSC (return of spontaneous circulation) \< 4 hours
You may not qualify if:
- recent maxillofacial surgery
- participation in other clinical trials
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Medical Center Leeuwarden
Leeuwarden, 8934 AD, Netherlands
Related Publications (1)
Koopmans M, Kuiper MA, Endeman H, Veenstra G, Vellinga NA, de Vos R, Boerma EC. Microcirculatory perfusion and vascular reactivity are altered in post cardiac arrest patients, irrespective of target temperature management to 33 degrees C vs 36 degrees C. Resuscitation. 2015 Jan;86:14-8. doi: 10.1016/j.resuscitation.2014.09.025. Epub 2014 Oct 18.
PMID: 25449350DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
Relative small sample size Large inter individual variability in microvascular reactivity
Results Point of Contact
- Title
- Matty Koopmans, MSc
- Organization
- Medical Center Leeuwarden
Study Officials
- PRINCIPAL INVESTIGATOR
Matty Koopmans, RN
medical center leeuwarden
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- observational
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- RN
Study Record Dates
First Submitted
April 23, 2012
First Posted
May 9, 2013
Study Start
February 1, 2012
Primary Completion
January 1, 2013
Study Completion
May 1, 2013
Last Updated
June 25, 2015
Results First Posted
June 25, 2015
Record last verified: 2015-06