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

An observational study of Cardiac Arrest, run by Frisius Medisch Centrum at 1 site in Netherlands.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Cardiac Arrest
What is being tested?: microcirculation by SDF and NIRS, in 33 and 36 degrees
Type of treatment: Medical device
How many people: 22 participants
Where: 1 siteNetherlands
Study dates: Feb 2012to May 2013
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: patients after out of hospital cardiac arrest

Who may be able to join

out-of-hospital cardiac arrest
> 18 years
informed consent
ROSC (return of spontaneous circulation) < 4 hours

Who cannot join

recent maxillofacial surgery
participation in other clinical trials

Trial locations and contacts

1 site in 1 country.

Netherlands1 site

Medical Center Leeuwarden
Leeuwarden, 8934 AD

Other trials in Netherlands

About this study

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

Read the 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.

Conditions: Cardiac Arrest
Being tested: microcirculation by SDF and NIRS, in 33 and 36 degrees
Keywords: cardiac arrest, therapeutic hypothermia, microcirculation
Medical subject headings: Heart Arrest

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

microcirculation by SDF and NIRS, in 33 and 36 degreesDevice
Also called measurements of the microcirculation by SDF and NIRS, in both arms
at baseline, after 12 and 24 hours in both arms

Study groups in NCT01850485
Study group	Role	What they receive
normothermia, 36 degrees		microcirculation after cardiac arrest by SDF and NIRS, in patients treated with 36 degrees, difference is temperature, in this group 36 Receives: Device: microcirculation by SDF and NIRS, in 33 and 36 degrees
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 Receives: Device: microcirculation by SDF and NIRS, in 33 and 36 degrees

What is being measured

The primary outcome is the main question the study is designed to answer.

Microvascular Flow Index (MFI)
Microvascular Flow Index; minimum score = 0 (= no flow) and maximum score = 3 (=normal flow)
Measured: baseline measurement

Secondary outcomes (6)

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 2012May 2013

First posted9 May 2013 (estimated)
Study startFeb 2012
Primary completionJan 2013
Study completionMay 2013

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Cardiac ArrestStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Time perspective: Prospective
Enrolment: 22 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01850485
Sponsor's protocol ID: TPO 745
Status last verified: Jun 2015
First submitted: 23 Apr 2012
Last updated: 25 Jun 2015
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

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.
PubMed 25449350

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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AI-powered ECG Analysis Using Willem™ Software in High-risk Cardiac Patients (WILLEM)
Cardiomyopathies, Cardiac Arrest
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Assessment of Combined CCM and ICD Device in HFrEF
Heart Failure, Heart Failure With Reduced Ejection Fraction
Not yet recruitingObservational study
CAROTID DOPPLER AND CEREBRAL OXIMERY IN POST CARDIAC ARREST ICU PATIENTS
Cardiac Arrest (CA), Carotid Doppler
Active, not recruitingPhase 3
The Danish Out-of-Hospital Cardiac Arrest Study
Out-Of-Hospital Cardiac Arrest, Post-Cardiac Arrest Syndrome
RecruitingObservational study
Evaluation of Acid-base Disorders and Ventilation Settings in Cardiogenic Shock and Post-cardiac Arrest Patients: Comparison With VentilO Algorithm
Cardiac Arrest (CA), Cardiogenic Shock

All Cardiac Arrest trials

Study at a glance

From the registry record, last updated by the sponsor on 25 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT01850485
Acronym / sponsor ID: TPO 745
Conditions: Cardiac Arrest
Keywords: cardiac arrest, therapeutic hypothermia, microcirculation
Study type: Observational
Recruitment status: Completed
Enrolment: 22 participants (actual)
Lead sponsor: Frisius Medisch CentrumUniversity, hospital or other
Study start: Feb 2012
Primary completion: Jan 2013 (actual)
Study completion: May 2013 (actual)
First posted: 9 May 2013 (estimated)
Results: Posted 25 Jun 2015

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Time perspective: Prospective
Number of arms: 2

Arm	Type	Receives
normothermia, 36 degrees	–	Device: microcirculation by SDF and NIRS, in 33 and 36 degreesmicrocirculation after cardiac arrest by SDF and NIRS, in patients treated with 36 degrees, difference is temperature, in this group 36
33 degrees, therapeutic hypothermia	–	Device: microcirculation by SDF and NIRS, in 33 and 36 degreesmicrocirculation after cardiac arrest by SDF and NIRS, in patients treated with 33 degrees, difference is temperature, in this group 33

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: patients after out of hospital cardiac arrest

Key inclusion criteria (4 listed)

out-of-hospital cardiac arrest
> 18 years
informed consent
ROSC (return of spontaneous circulation) < 4 hours

Key exclusion criteria (2 listed)

recent maxillofacial surgery
participation in other clinical trials

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
microcirculation by SDF and NIRS, in 33 and 36 degreesAlso: measurements of the microcirculation by SDF and NIRS, in both armsat baseline, after 12 and 24 hours in both arms	Device	33 degrees, therapeutic hypothermia, normothermia, 36 degrees

Primary outcome

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

6 secondary outcomes

RincStO2
Time frame: baseline
Fluid Balance After 24 Hours
Time frame: 24 hours
Inotropes and Vasopressor Dose
Time frame: baseline
Cardiac Index
Time frame: 24 hours
Lactate
Time frame: 24 hours
SvO2
Time frame: 24 hours

Results and safety

Results posted to the registry on 25 Jun 2015, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Normothermia, 36 Degrees	9	9
33 Degrees, Therapeutic Hypothermia	13	13

Primary outcome: Microvascular Flow Index (MFI)

Time frame: baseline measurement. Median (Inter-Quartile Range). Unit: units on a scale

Measure	Normothermia, 36 Degrees n = 9	33 Degrees, Therapeutic Hypothermia n = 13
Value	1.7 (0.7 to 2.4)	1.1 (0.4 to 1.9)

6 secondary outcomes are reported in the full results.

Adverse events

Time frame: 11 months. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Normothermia, 36 Degrees	0 of 9 (0%)	0 of 9 (0%)	Not reported
33 Degrees, Therapeutic Hypothermia	0 of 13 (0%)	0 of 13 (0%)	Not reported

Limitations and caveats (from the sponsor): Relative small sample size Large inter individual variability in microvascular reactivity

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2015.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 25449350Koopmans 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.

Related trials for Cardiac Arrest

RecruitingObservational study
AI-powered ECG Analysis Using Willem™ Software in High-risk Cardiac Patients (WILLEM)
Cardiomyopathies, Cardiac Arrest
Active, not recruiting
Assessment of Combined CCM and ICD Device in HFrEF
Heart Failure, Heart Failure With Reduced Ejection Fraction
Not yet recruitingObservational study
CAROTID DOPPLER AND CEREBRAL OXIMERY IN POST CARDIAC ARREST ICU PATIENTS
Cardiac Arrest (CA), Carotid Doppler
Active, not recruitingPhase 3
The Danish Out-of-Hospital Cardiac Arrest Study
Out-Of-Hospital Cardiac Arrest, Post-Cardiac Arrest Syndrome
RecruitingObservational study
Evaluation of Acid-base Disorders and Ventilation Settings in Cardiogenic Shock and Post-cardiac Arrest Patients: Comparison With VentilO Algorithm
Cardiac Arrest (CA), Cardiogenic Shock

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Matty Koopmans, RN principal investigator

medical center leeuwarden

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Cardiac Arrest, run by Frisius Medisch Centrum at 1 site in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 25 Jun 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Microvascular Flow Index (MFI) (time frame: baseline measurement). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01850485, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2015.