Ocular Microvascular Changes in Patients With Sepsis

Completed

• Conditions: Retinal Microcirculation Disorder; Conjunctiva; Disorder; Sepsis

• Registration Number: NCT04214743
• Lead Sponsor: Lithuanian University of Health Sciences

Brief 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

Detailed 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.

Study Timeline

• Study Start: 2018-01-02
• Primary Completion: 2019-08-31
• Study Completion: 2019-08-31
• Status Verified: 2019-12
• Study First Submitted: 2019-12-28
• Study First Submitted QC: 2019-12-30
• Last Update Submitted: 2019-12-30
• Study First Posted: 2020-01-02
• Last Update Posted: 2020-01-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 76

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Microvascular flow index in conjunctival small vessels	24 hours	Differences in MFI in conjunctival small vessels between septic patients and healthy controls and differences between survivors and non-survivors

Secondary Outcome Measures

Name	Time	Method
Central retinal arteriolar equivalent of retinal vessels	24 hours	Differences in central retinal arteriolar equivalent of retinal vessels between septic patients and healthy controls and differences between survivors and non-survivors

Trial Locations

Locations (1)

Hospital of Lithuanian university of health sciences; 🇱🇹 Kaunas, Lithuania