Alterations of Conjunctival Microcirculation in Brain Dead Patients

Brain Death Clinical Trial

Official title:

Alterations of Conjunctival Microcirculation in Brain Dead Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02483273
• Other study ID #: P1-BE-2-19/2011
• Status: Completed
• Phase: N/A
• First received: June 18, 2015
• Last updated: March 2, 2016
• Start date: May 2011
• Est. completion date: March 2016

Study information

• Verified date: March 2016
• Source: Lithuanian University of Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: Lithuania: Bioethics Committee
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: March 2016
• Est. primary completion date: September 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Diagnosed brain dead

Exclusion Criteria:

• Conjunctival or sublingual mucosa damage

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Brain Death

Locations

Country	Name	City	State
Lithuania	Lithuanian University of Health Sciences	Kaunas

Sponsors (1)

Lead Sponsor	Collaborator
Lithuanian University of Health Sciences

Country where clinical trial is conducted

Lithuania, 

References & Publications (7)

De Backer D, Hollenberg S, Boerma C, Goedhart P, Büchele 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. — View Citation

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. Review. — View Citation

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. — View Citation

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. — View 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. — View 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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Microvascular flow index (MFI) of ocular conjunctiva.	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.	No
Primary	Total vessel density (TVD) of ocular concunctiva.	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.	No
Primary	Perfused vessel density (PVD) of ocular conjunctiva.	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.	No
Secondary	Microvascular flow index (MFI) of sublingual mucosa.	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.	No
Secondary	Total vessel density (TVD) of sublingual mucosa.	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.	No
Secondary	Perfused vessel density (PVD) of sublingual mucosa.	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.	No