CClinicalTrials.gg
CompletedNCT04214743Updated Jan 2, 2020

Ocular Microvascular Changes in Patients With Sepsis

An observational study in Sepsis, Retinal Microcirculation Disorder and Conjunctiva; Disorder, sponsored by Lithuanian University of Health Sciences. Completed at 1 site in Lithuania. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-01-02.

Sponsored by Lithuanian University of Health Sciences · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
76
Ages
18 Years and older
Sex
All
01

Study 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

Read the 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.

02

Conditions studied

  • Sepsis
  • Retinal Microcirculation Disorder
  • Conjunctiva; Disorder

Browse trials for

Keywords

  • Conjunctival microcirculation
  • retinal vessels
  • fundus imaging
  • IDF imaging
  • sepsis
03

In context

Sepsis

1,894 studies on the registry are indexed under Sepsis; 458 are open to participants now.

This study's enrollment of 76 is below the median of 160 across 929 observational studies indexed under Sepsis.

Browse Sepsis studies →

Lead sponsor

Lithuanian University of Health Sciences is the lead sponsor of 102 studies on the registry; 31 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

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

Inclusion criteria

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

Exclusion criteria

Exclusion Criteria:

  • psychiatric disorders, brain diseases, chronic alcoholism, autoimmune rheumatic diseases
  • ophthalmological diseases, such as glaucoma, age-related macular degeneration, diabetic retinopathy and cataract
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
76 participants (actual)
Patient registry
No

Interventions

  • DeviceIncident dark field videomicroscope from Braedius

    It allows to look at conjunctival microcirculation

  • DeviceFundus camera from Optomed

    It allows to monitor retinal microvasculature

06

What researchers measure

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

    Time frame: 24 hours

Secondary outcomes

  1. 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

    Time frame: 24 hours

07

Study locations

1 site
  • Hospital of Lithuanian university of health sciences
    Kaunas, LT-50161, Lithuania
08

References and documents

Publications

  • 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. PubMed 32266602 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jan 2, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04214743
Lead sponsor
Lithuanian University of Health Sciences
Collaborators
Research Council of Lithuania
Responsible party
Andrius Pranskunas (MD, Lithuanian University of Health Sciences) — Principal investigator
First posted
Jan 2, 2020
Start date
Jan 2, 2018
Primary completion
Aug 31, 2019
Completion
Aug 31, 2019
Last update
Jan 2, 2020

Study contacts

Andrius o Pranskunas
principal investigator · Lithuanian University of Health Sciences

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2019. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion