- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02483273
Alterations of Conjunctival Microcirculation in Brain Dead Patients
Study Overview
Status
Conditions
Detailed Description
Microcirculation videomicroscopy techniques are used to evaluate a global organ perfusion in various critical conditions using limited suitable sites available for visualisation. However, ocular microcirculation may become a window to specifically cerebral perfusion due to related blood supply, close anatomical proximity and easy accessibility for videomicroscopy. Cerebral perfusion mainly depends on cerebral flow and intracranial pressure and therefore we aim, for the first time, to demonstrate microcirculatory status of ocular conjunctiva in clinical conditions when cerebral flow is completely absent.
In a single center open label observational study investigators analyzed conjunctival and sublingual microcirculation using SDF videomicroscopy in brain dead patients after reaching systemic hemodynamic targets to optimise perfusion of donor organs. All brain death diagnoses were confirmed by cerebral angiography. Microcirculatory images obtained and analyzed using standardized published recommendations by experts in this field. Microcirculation of sublingual and conjunctival areas were recorded in matching number of healthy volunteers using same techniques.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Kaunas, Lithuania
- Lithuanian University of Health Sciences
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Diagnosed brain dead
Exclusion Criteria:
- Conjunctival or sublingual mucosa damage
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
---|
Brain dead patients
Brain dead patients certified by cerebral angiography.
|
Healthy volunteers
Any person with no known cerebral pathology.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Microvascular flow index (MFI) of ocular conjunctiva.
Time Frame: After confirmed diagnosis of brain death of any course using cerebral angiography at any time up to 24 hours.
|
Conjunctival convective oxygen transport presented as MFI of small vessels mostly capillaries with diameter cutoff value of 20µm.
Images of microcirculation were taken from at least three different points in each ocular conjunctiva and recorded for at least 20 seconds avoiding pressure artifacts.
Microcirculation images were obtained using SDF videomicroscopy (Microscan®, Microvision Medicals, Amsterdam, Netherlands).
Data recorded to the hard drive of personal computer using AVA 3.0v software (Microvision Medical, Amsterdam, Netherlands).
Video clips were then randomly blinded and later analyzed by 2 independent investigators.
|
After confirmed diagnosis of brain death of any course using cerebral angiography at any time up to 24 hours.
|
Total vessel density (TVD) of ocular concunctiva.
Time Frame: After confirmed diagnosis of brain death of any course using cerebral angiography at any time up to 24 hours.
|
Conjunctival microvascular diffusion distance presented as TVD (mm/mm²) of small vessels mostly capillaries with diameter cutoff value of 20µm.
Images of microcirculation were taken from at least three different points in each ocular conjunctiva and recorded for at least 20 seconds avoiding pressure artifacts.
Microcirculation images were obtained using SDF videomicroscopy (Microscan®, Microvision Medicals, Amsterdam, Netherlands).
Data recorded to the hard drive of personal computer using AVA 3.0v software (Microvision Medical, Amsterdam, Netherlands).
Video clips were then randomly blinded and later analyzed by 2 independent investigators.
|
After confirmed diagnosis of brain death of any course using cerebral angiography at any time up to 24 hours.
|
Perfused vessel density (PVD) of ocular conjunctiva.
Time Frame: After confirmed diagnosis of brain death of any course using cerebral angiography at any time up to 24 hours.
|
Conjunctival microvascular diffusion distance presented as PVD (mm/mm²) of small vessels mostly capillaries with diameter cutoff value of 20µm.
Images of microcirculation were taken from at least three different points in each ocular conjunctiva and recorded for at least 20 seconds avoiding pressure artifacts.
Microcirculation images were obtained using SDF videomicroscopy (Microscan®, Microvision Medicals, Amsterdam, Netherlands).
Data recorded to the hard drive of personal computer using AVA 3.0v software (Microvision Medical, Amsterdam, Netherlands).
Video clips were then randomly blinded and later analyzed by 2 independent investigators
|
After confirmed diagnosis of brain death of any course using cerebral angiography at any time up to 24 hours.
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Microvascular flow index (MFI) of sublingual mucosa.
Time Frame: After confirmed diagnosis of brain death of any course using cerebral angiography at any time up to 24 hours.
|
Sublingual mucosa convective oxygen transport presented as MFI of small vessels mostly capillaries with diameter cutoff value of 20µm.
Images of microcirculation were taken from at least three different points in sublingual mucosa and recorded for at least 20 seconds avoiding pressure artifacts.
Microcirculation images were obtained using SDF videomicroscopy (Microscan®, Microvision Medicals, Amsterdam, Netherlands).
Data recorded to the hard drive of personal computer using AVA 3.0v software (Microvision Medical, Amsterdam, Netherlands).
Video clips were then randomly blinded and later analyzed by 2 independent investigators.
|
After confirmed diagnosis of brain death of any course using cerebral angiography at any time up to 24 hours.
|
Total vessel density (TVD) of sublingual mucosa.
Time Frame: After confirmed diagnosis of brain death of any course using cerebral angiography at any time up to 24 hours.
|
Sublingual mucosa microvascular diffusion distance presented as TVD (mm/mm²) of small vessels mostly capillaries with diameter cutoff value of 20µm.
Images of microcirculation were taken from at least three different points in sublingual mucosa and recorded for at least 20 seconds avoiding pressure artifacts.
Microcirculation images were obtained using SDF videomicroscopy (Microscan®, Microvision Medicals, Amsterdam, Netherlands).
Data recorded to the hard drive of personal computer using AVA 3.0v software (Microvision Medical, Amsterdam, Netherlands).
Video clips were then randomly blinded and later analyzed by 2 independent investigators.
|
After confirmed diagnosis of brain death of any course using cerebral angiography at any time up to 24 hours.
|
Perfused vessel density (PVD) of sublingual mucosa.
Time Frame: After confirmed diagnosis of brain death of any course using cerebral angiography at any time up to 24 hours.
|
Sublingual mucosa microvascular diffusion distance presented as PVD (mm/mm²) of small vessels mostly capillaries with diameter cutoff value of 20µm.
Images of microcirculation were taken from at least three different points in sublingual mucosa and recorded for at least 20 seconds avoiding pressure artifacts.
Microcirculation images were obtained using SDF videomicroscopy (Microscan®, Microvision Medicals, Amsterdam, Netherlands).
Data recorded to the hard drive of personal computer using AVA 3.0v software (Microvision Medical, Amsterdam, Netherlands).
Video clips were then randomly blinded and later analyzed by 2 independent investigators.
|
After confirmed diagnosis of brain death of any course using cerebral angiography at any time up to 24 hours.
|
Collaborators and Investigators
Investigators
- Principal Investigator: Vidas Pilvinis, MD,PhD, Lithuanian UHS Intensive Care Clinic
Publications and helpful links
General Publications
- Ragauskas A, Matijosaitis V, Zakelis R, Petrikonis K, Rastenyte D, Piper I, Daubaris G. Clinical assessment of noninvasive intracranial pressure absolute value measurement method. Neurology. 2012 May 22;78(21):1684-91. doi: 10.1212/WNL.0b013e3182574f50. Epub 2012 May 9.
- Goedhart PT, Khalilzada M, Bezemer R, Merza J, Ince C. Sidestream Dark Field (SDF) imaging: a novel stroboscopic LED ring-based imaging modality for clinical assessment of the microcirculation. Opt Express. 2007 Nov 12;15(23):15101-14. doi: 10.1364/oe.15.015101.
- De Backer D, Hollenberg S, Boerma C, Goedhart P, Buchele G, Ospina-Tascon G, Dobbe I, Ince C. How to evaluate the microcirculation: report of a round table conference. Crit Care. 2007;11(5):R101. doi: 10.1186/cc6118.
- De Backer D, Ospina-Tascon G, Salgado D, Favory R, Creteur J, Vincent JL. Monitoring the microcirculation in the critically ill patient: current methods and future approaches. Intensive Care Med. 2010 Nov;36(11):1813-25. doi: 10.1007/s00134-010-2005-3. Epub 2010 Aug 6.
- Schaser KD, Settmacher U, Puhl G, Zhang L, Mittlmeier T, Stover JF, Vollmar B, Menger MD, Neuhaus P, Haas NP. Noninvasive analysis of conjunctival microcirculation during carotid artery surgery reveals microvascular evidence of collateral compensation and stenosis-dependent adaptation. J Vasc Surg. 2003 Apr;37(4):789-97. doi: 10.1067/mva.2003.139.
- Miller MM, Chang T, Keating R, Crouch E, Sable C. Blood flow velocities are reduced in the optic nerve of children with elevated intracranial pressure. J Child Neurol. 2009 Jan;24(1):30-5. doi: 10.1177/0883073808321050.
- Pranskunas A, Vellinga NA, Pilvinis V, Koopmans M, Boerma EC. Microcirculatory changes during open label magnesium sulphate infusion in patients with severe sepsis and septic shock. BMC Anesthesiol. 2011 Jun 14;11:12. doi: 10.1186/1471-2253-11-12.
- Tamosuitis T, Pranskunas A, Balciuniene N, Pilvinis V, Boerma EC. Conjunctival microcirculatory blood flow is altered but not abolished in brain dead patients: a prospective observational study. BMC Neurol. 2016 Jul 11;16:95. doi: 10.1186/s12883-016-0618-z.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- P1-BE-2-19/2011
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Brain Death
-
Liu YonghongEnrolling by invitationSudden Unexpected Death in Epilepsy | Near-Sudden Unexpected Death in EpilepsyChina
-
Hospices Civils de LyonTerminatedSudden Unexpected Death in Epilepsy (SUDEP)France
-
Centre Hospitalier Universitaire de NīmesTerminatedStress Disorders, Post-TraumaticFrance
-
Brigham and Women's HospitalNot yet recruitingEpilepsyUnited States
-
NYU Langone HealthRecruiting
-
Alexandria UniversityUnknownMaternal Death | Hypoxic Brain InjuryEgypt
-
Indiana UniversityGreenwich Biosciences; Child Neurology FoundationCompleted
-
Instituto de Investigación Hospital Universitario...Hospital de Santa Maria, PortugalCompletedPrevention of Kidney Injury Associated With Brain DeathSpain, Portugal
-
Fundació Institut de Recerca de l'Hospital de la...UnknownBiomarkers | Cardiac Sudden Death | Hypoxia Brain | Cell Membrane MicroparticlesSpain
-
Gorm GreisenCopenhagen Trial Unit, Center for Clinical Intervention Research; Elsass FoundationCompletedBrain Injuries | Infant, Extremely Premature | Death; Neonatal | Death, BrainDenmark