Endothelial DysfunctionNCT03216850
Evaluation of Lipid Emulsion on GCX in Critically Ill Patients
An observational study of Endothelial Dysfunction, run by University Hospital Hradec Kralove at 1 site in Czechia.
Trial summary
Characterisation of the lipidome and parenteral nutrition modulate the endothelial glycocalyx. The aim of the study A is to detect any influence of the lipid emulsion on the endothelial glycocalyx in patients in critical care. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Endothelial Dysfunction
- What is being tested?
- Sublingual microcirculation assessment
- Type of treatment
- Medical device
- How many people
- 15 participants
- Where
- 1 siteCzechia
- Study dates
- 1 Jan 2018to 31 Dec 2018
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Adult, Older adult
Study population: All patients who meet the inclusion criteria admitted to the ICU.
Who may be able to join
- patients in ICU
- indication for lipid administration as a part of TPN
Who cannot join
- shock or clinical/laboratory signs of tissue hypoperfusion
- previous lipid infusions (within 3 months before entering study)
- hyperlipidaemia
- hyperglycaemia (over 10 mmol/l)
- current or previous (within 72 hours before entering the study) use of propofol
- pancreatitis
- severe liver failure
- current use of statins
Trial locations and contacts
1 site in 1 country.
Czechia1 site
University Hospital Hradec Kralove
Hradec Králové, Třebeš, 50005
About this study
Official title: Alterations of Glycocalyx in Critical Illness and During Major Surgery and Approaches for Glycocalyx Protection. Effect of Parenteral Nutrition and Plasma Lipidome on GCX
Characterisation of the lipidome and parenteral nutrition modulate the endothelial glycocalyx.
The aim of the study A is to detect any influence of the lipid emulsion on the endothelial glycocalyx in patients in critical care. The targeted cohort is patients on ICU with an indication for parenteral nutrition including lipid emulsion. 15 patients are planned to be enrolled.
Monitored variables: demographic data, type of the population, type of the lipid emulsion, selected variables of the lipid metabolism, sublingual microcirculation (SDF imaging),
- Conditions
- Endothelial Dysfunction
- Being tested
- Sublingual microcirculation assessment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sublingual microcirculation assessmentDevice
Non-invasive investigation of the endothelial glycocalyx in the sublingual microcirculation.
| Study group | Role | What they receive |
|---|---|---|
| Patients in ICU requiring parenteral nutrition | Not described Receives: Device: Sublingual microcirculation assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Endothelial Glycocalyx Thickness
Endothelial glycocalyx thickness was measured indirectly by PBR, which is a lateral movement of the red blood cells from the median column in the microcirculation in micrometers. The higher the PBR is the more damaged the endothelial glycocalyx is.
Measured: One week within the ICU care
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2017
- Study start1 Jan 2018
- Primary completion31 Aug 2018
- Study completion31 Dec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Endothelial DysfunctionStudies 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
- 15 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
- Investigators
- Vladimir Cerny, MD, Principal investigator, University Hospital Hradec Kralove
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03216850
- Sponsor's protocol ID
- AZVCR 9307_5/a
- Status last verified
- Nov 2019
- First submitted
- 11 Jul 2017
- Last updated
- 27 Nov 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Alterations of Glycocalyx in Critical Illness and During Major Surgery and Approaches for Glycocalyx Protection. Effect of Parenteral Nutrition and Plasma Lipidome on GCX
- ClinicalTrials.gov ID
- NCT03216850
- Acronym / sponsor ID
- AZVCR 9307_5/a
- Conditions
- Endothelial Dysfunction
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University Hospital Hradec KraloveUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 31 Aug 2018 (actual)
- Study completion
- 31 Dec 2018 (actual)
- First posted
- 13 Jul 2017 (actual)
- Results
- Posted 27 Nov 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Characterisation of the lipidome and parenteral nutrition modulate the endothelial glycocalyx.
The aim of the study A is to detect any influence of the lipid emulsion on the endothelial glycocalyx in patients in critical care. The targeted cohort is patients on ICU with an indication for parenteral nutrition including lipid emulsion. 15 patients are planned to be enrolled.
Monitored variables: demographic data, type of the population, type of the lipid emulsion, selected variables of the lipid metabolism, sublingual microcirculation (SDF imaging),
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients in ICU requiring parenteral nutrition | – | Device: Sublingual microcirculation assessment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- All patients who meet the inclusion criteria admitted to the ICU.
Key inclusion criteria (2 listed)
- patients in ICU
- indication for lipid administration as a part of TPN
Key exclusion criteria (8 listed)
- shock or clinical/laboratory signs of tissue hypoperfusion
- previous lipid infusions (within 3 months before entering study)
- hyperlipidaemia
- hyperglycaemia (over 10 mmol/l)
- current or previous (within 72 hours before entering the study) use of propofol
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 |
|---|---|---|
| Sublingual microcirculation assessmentNon-invasive investigation of the endothelial glycocalyx in the sublingual microcirculation. | Device | Patients in ICU requiring parenteral nutrition |
Primary outcome
Endothelial Glycocalyx Thickness
Time frame: One week within the ICU care
Endothelial glycocalyx thickness was measured indirectly by PBR, which is a lateral movement of the red blood cells from the median column in the microcirculation in micrometers. The higher the PBR is the more damaged the endothelial glycocalyx is.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
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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.
Vladimir Cerny, MD principal investigator
University Hospital Hradec Kralove
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 Endothelial Dysfunction, 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 2 inclusion and 8 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 27 Nov 2019. 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?
Yes. Results are posted in the registry (first posted 27 Nov 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Endothelial Glycocalyx Thickness (time frame: One week within the ICU care). 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 27 Nov 2019.