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OpenTrials
Completed

NCT Number: NCT01850485

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

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.

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Key information

Conditions

Cardiac Arrest Cardiovascular Diseases Heart Arrest Heart Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Medical Center Leeuwarden

Leeuwarden, 8934 AD, Netherlands

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

microcirculation by SDF and NIRS, in 33 and 36 degrees

Device

at baseline, after 12 and 24 hours in both arms

Other names: measurements of the microcirculation by SDF and NIRS, in both arms

Primary outcomes

  1. Microvascular Flow Index (MFI)

    Time frame: baseline measurement

    Microvascular Flow Index; minimum score = 0 (= no flow) and maximum score = 3 (=normal flow)

Secondary outcomes

  1. RincStO2

    Time frame: baseline

    tissue oxygenation measured by Near Infrared Spectroscopy

  2. Fluid Balance After 24 Hours

    Time frame: 24 hours

  3. Inotropes and Vasopressor Dose

    Time frame: baseline

  4. Cardiac Index

    Time frame: 24 hours

    Cardiac Index is cardiac output indexed for body weight

  5. Lactate

    Time frame: 24 hours

    lactate levels in serum

  6. SvO2

    Time frame: 24 hours

    (venous oxygen saturation)

Sponsors and collaborators

Lead sponsor

Frisius Medisch Centrum

Other

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
May 9, 2013
Registry last updated
Jun 25, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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