Clinical trial NCT02483273: Alterations of Conjunctival Microcirculation in Brain Dead Patients
Official title: Alterations of Conjunctival Microcirculation in Brain Dead Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Brain Death
Keywords: Conjunctival microcirculation
Sublingual microcirculation
Sidestream Dark Field (SDF) microscopy
Lead sponsor: Lithuanian University of Health Sciences
Sponsor class: OTHER
First posted: 2015-06-26
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All single center tertiary level Neurosurgery Intensive Care unit patients angiographically confirmed brain dead.

Brief summary: Study hypothesize that ocular microcirculation is reflecting cerebral perfusion. The purpose of this study is to evaluate ocular microcirculation in brain dead patients using side dark field (SDF) videomicroscope and compare it with microcirculatory parameters of healthy volunteers.

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.

Eligibility criteria: Inclusion Criteria:

* Diagnosed brain dead

Exclusion Criteria:

* Conjunctival or sublingual mucosa damage

Primary outcomes:
measure: Microvascular flow index (MFI) of ocular conjunctiva.
timeFrame: After confirmed diagnosis of brain death of any course using cerebral angiography at any time up to 24 hours.
measure: Total vessel density (TVD) of ocular concunctiva.
timeFrame: After confirmed diagnosis of brain death of any course using cerebral angiography at any time up to 24 hours.
measure: Perfused vessel density (PVD) of ocular conjunctiva.
timeFrame: After confirmed diagnosis of brain death of any course using cerebral angiography at any time up to 24 hours.
Secondary outcomes:
measure: Microvascular flow index (MFI) of sublingual mucosa.
timeFrame: After confirmed diagnosis of brain death of any course using cerebral angiography at any time up to 24 hours.
measure: Total vessel density (TVD) of sublingual mucosa.
timeFrame: After confirmed diagnosis of brain death of any course using cerebral angiography at any time up to 24 hours.
measure: Perfused vessel density (PVD) of sublingual mucosa.
timeFrame: After confirmed diagnosis of brain death of any course using cerebral angiography at any time up to 24 hours.
Other outcomes:
Locations:
city: Kaunas
country: Lithuania
facility: Lithuanian University of Health Sciences
Study officials:
affiliation: Lithuanian UHS Intensive Care Clinic
name: Vidas Pilvinis, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: 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.
citation: 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.
citation: 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.