Ocular Microvascular Changes in Patients With Sepsis

Sepsis Clinical Trial

Official title:

Ocular Microvascular Changes in Patients With Sepsis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04214743
• Other study ID #: 2018/BE-2-18
• Status: Completed
• Start date: January 2, 2018
• Est. completion date: August 31, 2019

Study information

• Verified date: December 2019
• Source: Lithuanian University of Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 76
• Est. completion date: August 31, 2019
• Est. primary completion date: August 31, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Conjunctiva; Disorder
• Conjunctival Diseases
• Disease
• Retinal Microcirculation Disorder
• Sepsis
• Toxemia

Intervention

Device:
• Incident dark field videomicroscope from Braedius
It allows to look at conjunctival microcirculation
• Fundus camera from Optomed
It allows to monitor retinal microvasculature

Locations

Country	Name	City	State
Lithuania	Hospital of Lithuanian university of health sciences	Kaunas

Sponsors (2)

Lead Sponsor	Collaborator
Lithuanian University of Health Sciences	Research Council of Lithuania

Country where clinical trial is conducted

Lithuania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Microvascular flow index in conjunctival small vessels	Differences in MFI in conjunctival small vessels between septic patients and healthy controls and differences between survivors and non-survivors	24 hours
Secondary	Central retinal arteriolar equivalent of retinal vessels	Differences in central retinal arteriolar equivalent of retinal vessels between septic patients and healthy controls and differences between survivors and non-survivors	24 hours