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

NCT ID: NCT01850485

Last Updated: 2015-06-25

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

22 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-02-29

Study Completion Date

2013-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Cardiac Arrest

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

normothermia, 36 degrees

microcirculation after cardiac arrest by SDF and NIRS, in patients treated with 36 degrees, difference is temperature, in this group 36

microcirculation by SDF and NIRS, in 33 and 36 degrees

Intervention Type DEVICE

at baseline, after 12 and 24 hours 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

microcirculation by SDF and NIRS, in 33 and 36 degrees

Intervention Type DEVICE

at baseline, after 12 and 24 hours in both arms

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

microcirculation by SDF and NIRS, in 33 and 36 degrees

at baseline, after 12 and 24 hours in both arms

Intervention Type DEVICE

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

measurements of the microcirculation by SDF and NIRS in both arms

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Frisius Medisch Centrum

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Matty Koopmans

RN

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Matty Koopmans, RN

Role: PRINCIPAL_INVESTIGATOR

medical center leeuwarden

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Medical Center Leeuwarden

Leeuwarden, , Netherlands

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Netherlands

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 25449350 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

TPO 745

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Mild Hypothermia in Acute Ischemic Stroke
NCT00987922 COMPLETED PHASE2