SepsisNCT04214743
Ocular Microvascular Changes in Patients With Sepsis
An observational study of Sepsis and Retinal Microcirculation Disorder, run by Lithuanian University of Health Sciences at 1 site in Lithuania.
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 Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sepsis, Retinal Microcirculation Disorder, Conjunctiva; Disorder
- What is being tested?
- Incident dark field videomicroscope from Braedius and Fundus camera from Optomed
- Type of treatment
- Medical device
- How many people
- 76 participants
- Where
- 1 siteLithuania
- Study dates
- 2 Jan 2018to 31 Aug 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Adult patients with sepsis or septic shock within the first 24 hours after ICU admission
Who may be able to join
- adult patients with sepsis or septic shock within the first 24 hours after ICU admission
Who cannot join
- psychiatric disorders, brain diseases, chronic alcoholism, autoimmune rheumatic diseases
- ophthalmological diseases, such as glaucoma, age-related macular degeneration, diabetic retinopathy and cataract
Trial locations and contacts
1 site in 1 country.
Lithuania1 site
Hospital of Lithuanian university of health sciences
Kaunas, LT-50161
About this study
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.
- Being tested
- Incident dark field videomicroscope from Braedius, Fundus camera from Optomed
- Keywords
- Conjunctival microcirculation, retinal vessels, fundus imaging, IDF imaging, sepsis
- Medical subject headings
- Sepsis, Conjunctival Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Incident dark field videomicroscope from BraediusDevice
It allows to look at conjunctival microcirculation
Fundus camera from OptomedDevice
It allows to monitor retinal microvasculature
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2020
- Study start2 Jan 2018
- Primary completion31 Aug 2019
- Study completion31 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SepsisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lithuanian University of Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Research Council of Lithuania
- Responsible party
- Principal investigator, Andrius Pranskunas, Lithuanian University of Health Sciences
- Investigators
- Andrius o Pranskunas, Principal investigator, Lithuanian University of Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04214743
- Sponsor's protocol ID
- 2018/BE-2-18
- Status last verified
- Dec 2019
- First submitted
- 28 Dec 2019
- Last updated
- 2 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 2 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ocular Microvascular Changes in Patients With Sepsis
- ClinicalTrials.gov ID
- NCT04214743
- Acronym / sponsor ID
- 2018/BE-2-18
- Keywords
- Conjunctival microcirculation, retinal vessels, fundus imaging, IDF imaging, sepsis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Lithuanian University of Health SciencesUniversity, hospital or other
- Collaborators
- Research Council of Lithuania
- Study start
- 2 Jan 2018 (actual)
- Primary completion
- 31 Aug 2019 (actual)
- Study completion
- 31 Aug 2019 (actual)
- First posted
- 2 Jan 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with sepsis or septic shock within the first 24 hours after ICU admission
Key inclusion criteria (1 listed)
- adult patients with sepsis or septic shock within the first 24 hours after ICU admission
Key exclusion criteria (2 listed)
- psychiatric disorders, brain diseases, chronic alcoholism, autoimmune rheumatic diseases
- ophthalmological diseases, such as glaucoma, age-related macular degeneration, diabetic retinopathy and cataract
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Incident dark field videomicroscope from BraediusIt allows to look at conjunctival microcirculation | Device | – |
| Fundus camera from OptomedIt allows to monitor retinal microvasculature | Device | – |
Primary outcome
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
1 secondary outcome
Central retinal arteriolar equivalent of retinal vessels
Time frame: 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jan 2020.
- Derived from this study: PubMed 32266602Simkiene 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrius o Pranskunas principal investigator
Lithuanian University of Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sepsis and Retinal Microcirculation Disorder, run by Lithuanian University of Health Sciences at 1 site in Lithuania.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Lithuania. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Microvascular flow index in conjunctival small vessels (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04214743, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jan 2020.