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Completed

NCT Number: NCT04214743

Ocular Microvascular Changes in Patients With Sepsis

This study evaluates differences in the ocular microcirculation between septic patients and healthy subjects and the course of ocular microvasculature in survivors and non-survivors over a 24 hours period of time in septic patients

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Key information

Conditions

Sepsis Conjunctiva; Disorder Conjunctival Diseases Eye Diseases Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Retinal Microcirculation Disorder Systemic Inflammatory Response Syndrome

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital of Lithuanian university of health sciences

Kaunas, LT-50161, Lithuania

About this study

Conjunctival imaging, using IDF video microscope, and retinal imaging, using portable digital fundus camera, as well as systemic hemodynamic measurements, were performed in septic patients at three time points: at baseline, 6 hours and 24 hours. Baseline conjunctival and retinal microcirculatory parameters were compared with healthy controls.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • adult patients with sepsis or septic shock within the first 24 hours after ICU admission

Exclusion criteria

  • psychiatric disorders, brain diseases, chronic alcoholism, autoimmune rheumatic diseases
  • ophthalmological diseases, such as glaucoma, age-related macular degeneration, diabetic retinopathy and cataract

Treatment and study plan

Incident dark field videomicroscope from Braedius

Device

It allows to look at conjunctival microcirculation

Fundus camera from Optomed

Device

It allows to monitor retinal microvasculature

Primary outcomes

  1. Microvascular flow index in conjunctival small vessels

    Time frame: 24 hours

    Differences in MFI in conjunctival small vessels between septic patients and healthy controls and differences between survivors and non-survivors

Secondary outcomes

  1. Central retinal arteriolar equivalent of retinal vessels

    Time frame: 24 hours

    Differences in central retinal arteriolar equivalent of retinal vessels between septic patients and healthy controls and differences between survivors and non-survivors

Sponsors and collaborators

Lead sponsor

Lithuanian University of Health Sciences

Other

Collaborators

  • Research Council of Lithuania

Registry information

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Jan 2, 2020
Registry last updated
Jan 2, 2020

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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