Ocular Microvascular Changes in Patients With Sepsis

NCT04214743 | Completed

• 1 other identifier: 2018/BE-2-18
• Study Type: observational
• Target: 76
• Locations: 1 country
• Sites: 1

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

Conditions

Sepsis; Retinal Microcirculation Disorder; Conjunctiva; Disorder

Keywords

Conjunctival microcirculation; retinal vessels; fundus imaging; IDF imaging; sepsis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Central retinal arteriolar equivalent of retinal vessels

  24 hours

Interventions

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Lithuanian University of Health Sciences: lead
• Research Council of Lithuania: collaborator

Study Sites (1)

Hospital of Lithuanian university of health sciences

Kaunas, LT-50161, Lithuania

Location

Related Publications (1)

• Simkiene J, Pranskuniene Z, Vitkauskiene A, Pilvinis V, Boerma EC, Pranskunas A. Ocular microvascular changes in patients with sepsis: a prospective observational study. Ann Intensive Care. 2020 Apr 7;10(1):38. doi: 10.1186/s13613-020-00655-x.

  PMID: 32266602 DERIVED

MeSH Terms

Conditions

Sepsis; Conjunctival Diseases

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Eye Diseases

Study Officials

• Andrius o Pranskunas

  Lithuanian University of Health Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: December 28, 2019
• First Posted: January 2, 2020
• Study Start: January 2, 2018
• Primary Completion: August 31, 2019
• Study Completion: August 31, 2019
• Last Updated: January 2, 2020

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

LI (1)