Viral PneumoniaNCT04644302
Circulatory Coherence in COVID-19 and Non-COVID-19 Patients With Sepsis
An observational study of Viral Pneumonia and Sepsis, run by University Hospital Hradec Kralove at 1 site in Czechia.
Trial summary
This prospective observational pilot study investigates circulatory coherence in patients with COVID and non-COVID sepsis by comparison of microcirculation, endothelial glycocalyx, and clinical course Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Viral Pneumonia, Sepsis
- What is being tested?
- microcirculation recording
- How many people
- 28 participants
- Where
- 1 siteCzechia
- Study dates
- 1 Feb 2020to 1 Jul 2021
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients admitted to the ICU with signs of circulatory instability with any method of organ support. Patients expected to have a particular method of organ support for at least 3 days.
Who may be able to join
- adult
- ICU admission due to sepsis with organ failure
- need for organ support therapy (mechanical ventilation, CRRT, ECMO)
- clinical and/or laboratory signs of circulatory instability
Who cannot join
- family withdrawal/disagreement
- death within three days from ICU admission
Trial locations and contacts
1 site in 1 country.
Czechia1 site
University Hospital Hradec Kralove
Hradec Králové, Třebeš, 50005
About this study
Official title: Circulatory and Endothelial Coherence in COVID-19 and Non-COVID-19 Patients With Sepsis - Prospective, Observational Pilot Study
This prospective observational pilot study investigates circulatory coherence in patients with COVID and non-COVID sepsis by comparison of microcirculation, endothelial glycocalyx, and clinical course
Read the detailed description
This prospective observational pilot study investigates circulatory coherence in patients with COVID and non-COVID sepsis by comparison of microcirculation (sublingual area video recordings and biochemical parameters of endothelial cells activation and damage) endothelial glycocalyx (sublingual area video recordings and biochemical parameter of glycocalyx degradation), and clinical course.
- Conditions
- Viral Pneumonia, Sepsis
- Being tested
- microcirculation recording
- Keywords
- microcirculation, endothelial glycocalyx, COVID-19
- Medical subject headings
- Pneumonia, Viral, Sepsis, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
microcirculation recordingDiagnostic test
Also called biochemical markeres investigation
non-invasive recording of sublingual microcirculation and blood sampling together with regular withdraws
| Study group | Role | What they receive |
|---|---|---|
| non-COVID sepsis | Patients admitted to ICU with sepsis of non-COVID origin Receives: Diagnostic Test: microcirculation recording | |
| COVID sepsis | Patients admitted to ICU with sepsis of COVID origin Receives: Diagnostic Test: microcirculation recording |
What is being measured
The primary outcome is the main question the study is designed to answer.
change in Proportion of Perfused Vessels (PPV) parameter
PPV describes microcirculation dysfunction
Measured: 1st, 2nd and 3rd day
change in Syndecan-1 serum concentration
Syndecan-1 is a marker of endothelial glycocalyx
Measured: 1st, 2nd and 3rd day
Secondary outcomes (2)
change in albuminuria
albuminuria is a marker of glomerular endothelial cells dysfunction
Measured: 1st, 2nd and 3rd day
mortality in 28 days
mortality in 28 days from ICU admission
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2020
- Study start1 Feb 2020
- Primary completion1 Jul 2021
- Study completion1 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Viral PneumoniaStudies 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
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Hradec Kralove
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vladimir Cerny, University Hospital Hradec Kralove
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04644302
- Sponsor's protocol ID
- FNHK_IGS_8144
- Status last verified
- Sep 2021
- First submitted
- 24 Nov 2020
- Last updated
- 30 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Circulatory and Endothelial Coherence in COVID-19 and Non-COVID-19 Patients With Sepsis - Prospective, Observational Pilot Study
- ClinicalTrials.gov ID
- NCT04644302
- Acronym / sponsor ID
- FNHK_IGS_8144
- Conditions
- Viral Pneumonia, Sepsis
- Keywords
- microcirculation, endothelial glycocalyx, COVID-19
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- University Hospital Hradec KraloveUniversity, hospital or other
- Study start
- 1 Feb 2020 (actual)
- Primary completion
- 1 Jul 2021 (actual)
- Study completion
- 1 Jul 2021 (actual)
- First posted
- 25 Nov 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 prospective observational pilot study investigates circulatory coherence in patients with COVID and non-COVID sepsis by comparison of microcirculation, endothelial glycocalyx, and clinical course
Detailed description
This prospective observational pilot study investigates circulatory coherence in patients with COVID and non-COVID sepsis by comparison of microcirculation (sublingual area video recordings and biochemical parameters of endothelial cells activation and damage) endothelial glycocalyx (sublingual area video recordings and biochemical parameter of glycocalyx degradation), and clinical course.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| non-COVID sepsis | – | Diagnostic Test: microcirculation recordingPatients admitted to ICU with sepsis of non-COVID origin |
| COVID sepsis | – | Diagnostic Test: microcirculation recordingPatients admitted to ICU with sepsis of COVID origin |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients admitted to the ICU with signs of circulatory instability with any method of organ support. Patients expected to have a particular method of organ support for at least 3 days.
Key inclusion criteria (4 listed)
- adult
- ICU admission due to sepsis with organ failure
- need for organ support therapy (mechanical ventilation, CRRT, ECMO)
- clinical and/or laboratory signs of circulatory instability
Key exclusion criteria (2 listed)
- family withdrawal/disagreement
- death within three days from ICU admission
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 |
|---|---|---|
| microcirculation recordingAlso: biochemical markeres investigationnon-invasive recording of sublingual microcirculation and blood sampling together with regular withdraws | Diagnostic test | COVID sepsis, non-COVID sepsis |
Primary outcome
change in Proportion of Perfused Vessels (PPV) parameter
Time frame: 1st, 2nd and 3rd day
PPV describes microcirculation dysfunction
change in Syndecan-1 serum concentration
Time frame: 1st, 2nd and 3rd day
Syndecan-1 is a marker of endothelial glycocalyx
2 secondary outcomes
change in albuminuria
Time frame: 1st, 2nd and 3rd day
mortality in 28 days
Time frame: 30 days
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 30 Sep 2021.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Viral Pneumonia and Sepsis, run by University Hospital Hradec Kralove at 1 site in Czechia.
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 4 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 30 Sep 2021. 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 Czechia. 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?
change in Proportion of Perfused Vessels (PPV) parameter (time frame: 1st, 2nd and 3rd day). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 30 Sep 2021.