Glycocalyx Damage in Critically Ill Patients

An observational study of Critical Illness, run by University Hospital Hradec Kralove at 1 site in Czechia.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The hypothesis to be tested: GCX damage and its dynamics correlate to various patient related factors and to using organ-supporting measures. There is a correlation between length of organ support and GCX damage. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Critical Illness
What is being tested?: PBR assessment
Type of treatment: Medical device
How many people: 40 participants
Where: 1 siteCzechia
Study dates: 1 Nov 2015to 30 Jun 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
No healthy volunteers
Adult, Older adult

Study population: All patients admitted to ICU meeting inclusion criteria.

Who may be able to join

adult patients admitted to ICU
artifitial ventilation
renal replacement therapy
targeted temperatura management

Who cannot join

pregnant women

Trial locations and contacts

1 site in 1 country.

Czechia1 site

University Hospital Hradec Kralove
Hradec Králové, Třebeš, 50005

Other trials in Czechia

About this study

Official title: Alterations of Glycocalyx in Critical Illness and During Major Surgery and Approaches for Glycocalyx Protection

The aim of the study: Evaluation of the relationship between GCX damage and duration of various organ supporting measures.

Type of the study: Observational. Subjects: Adult patients admitted to ICU and requiring organ supporting therapy.

Sample size: We plan enrollment of 75 patients on invasive ventilatory support in the duration of least 5 days, 50 patients on renal supporting therapy lasting at least 5 days and 20 patients with target temperature management for neuroprotection.

Intervention: none Data to be recorded and analysed: Demographics, type of patients (trauma, post surgical, medical, after cardiac arrest), severity score - Apache II, SOFA, fluid balance, presence of delirium, clinical outcome, sublingual microcirculation by SDF imaging at time points: before or at the start of organ support, after 24 hours (day 1), day 3, 5, 7 and/or at discharge or before death, microcirculatory data, and Perfused Boundary Region.

Conditions: Critical Illness
Being tested: PBR assessment
Keywords: Glycocalyx
Medical subject headings: Critical Illness

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PBR assessmentDevice
Sublingual microcirculation will be investigated by specialized handheld videomicroscopy device for PBR index.

Study groups in NCT03146585
Study group	Role	What they receive
Patients on artificial ventilation		Not described Receives: Device: PBR assessment
Patients on renal replacement therapy		Not described Receives: Device: PBR assessment
Patients with targeted temperature management		Not described Receives: Device: PBR assessment

What is being measured

The primary outcome is the main question the study is designed to answer.

Perfused Boundary Region (PBR) in One Week
PBR is an indirect measure of assessment of the endothelial glycocalyx thickness in sublingual microcirculation.
Measured: One week on ICU

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Nov 201530 Jun 2018

First posted10 May 2017
Study start1 Nov 2015
Primary completion31 Dec 2017
Study completion30 Jun 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 Critical IllnessStudies 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: 40 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03146585
Sponsor's protocol ID: AZVCR 9307_3
Status last verified: Mar 2020
First submitted: 7 May 2017
Last updated: 30 Mar 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Undecided

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

RecruitingPhase 4
Effect of a Furosemide Stress Test-Guided Strategy on Liberation From Continuous Renal Replacement Therapy in Critically Ill Patients With Acute Kidney Injury
Acute Kidney Injury
Not yet recruiting
Building Resilience Through Anxiety Virtual Education in PICU Survivors
Critical Illness Recovery, Mental Health
Active, not recruiting
PICU Up!: A Pilot Stepped-wedge Trial of a Multicomponent Early Mobility Intervention for Critically Ill Children
Critical Illness
RecruitingPhase 3
A Trial of Adjunctive Fludrocortisone (50mcg, 100mcg or Placebo) in Critically Ill Patients With Septic Shock Receiving Hydrocortisone, Evaluating Survival and Functional Recovery and the Influence of Transcriptomic Response
Septic Shock
Not yet recruiting
Feasibility Study on the Use of a Walking Exoskeleton in the Intensive Care Unit
Neuromuscular Disease in Post-Intensive Care Syndrome

All Critical Illness trials

Study at a glance

From the registry record, last updated by the sponsor on 30 Mar 2020. 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
ClinicalTrials.gov ID: NCT03146585
Acronym / sponsor ID: AZVCR 9307_3
Conditions: Critical Illness
Keywords: Glycocalyx
Study type: Observational
Recruitment status: Completed
Enrolment: 40 participants (actual)
Lead sponsor: University Hospital Hradec KraloveUniversity, hospital or other
Study start: 1 Nov 2015 (actual)
Primary completion: 31 Dec 2017 (actual)
Study completion: 30 Jun 2018 (actual)
First posted: 10 May 2017 (actual)
Results: Posted 30 Mar 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

The aim of the study: Evaluation of the relationship between GCX damage and duration of various organ supporting measures.

Type of the study: Observational. Subjects: Adult patients admitted to ICU and requiring organ supporting therapy.

Study design

Observational model: Cohort
Time perspective: Prospective
Number of arms: 3

Arm	Type	Receives
Patients on artificial ventilation	–	Device: PBR assessment
Patients on renal replacement therapy	–	Device: PBR assessment
Patients with targeted temperature management	–	Device: PBR assessment

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: All patients admitted to ICU meeting inclusion criteria.

Key inclusion criteria (4 listed)

adult patients admitted to ICU
artifitial ventilation
renal replacement therapy
targeted temperatura management

Key exclusion criteria (1 listed)

pregnant women

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
PBR assessmentSublingual microcirculation will be investigated by specialized handheld videomicroscopy device for PBR index.	Device	Patients on artificial ventilation, Patients on renal replacement therapy, Patients with targeted temperature management

Primary outcome

Perfused Boundary Region (PBR) in One Week
Time frame: One week on ICU
PBR is an indirect measure of assessment of the endothelial glycocalyx thickness in sublingual microcirculation.

Results and safety

Results posted to the registry on 30 Mar 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Patients on Artificial Ventilation	25	25
Patients on Renal Replacement Therapy	10	10
Patients With Targeted Temperature Management	5	5

Primary outcome: Perfused Boundary Region (PBR) in One Week

Time frame: One week on ICU. Median (Inter-Quartile Range). Unit: micrometer

Measure	Patients on Artificial Ventilation n = 25	Patients on Renal Replacement Therapy n = 10	Patients With Targeted Temperature Management n = 5
Value	1.95 (1.77 to 2.12)	1.97 (1.75 to 2.12)	2.02 (1.71 to 2.15)

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events
Patients on Artificial Ventilation	0 of 0	0 of 0
Patients on Renal Replacement Therapy	0 of 0	0 of 0
Patients With Targeted Temperature Management	0 of 0	0 of 0

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Undecided

Related trials for Critical Illness

RecruitingPhase 4
Effect of a Furosemide Stress Test-Guided Strategy on Liberation From Continuous Renal Replacement Therapy in Critically Ill Patients With Acute Kidney Injury
Acute Kidney Injury
Not yet recruiting
Building Resilience Through Anxiety Virtual Education in PICU Survivors
Critical Illness Recovery, Mental Health
Active, not recruiting
PICU Up!: A Pilot Stepped-wedge Trial of a Multicomponent Early Mobility Intervention for Critically Ill Children
Critical Illness
RecruitingPhase 3
A Trial of Adjunctive Fludrocortisone (50mcg, 100mcg or Placebo) in Critically Ill Patients With Septic Shock Receiving Hydrocortisone, Evaluating Survival and Functional Recovery and the Influence of Transcriptomic Response
Septic Shock
Not yet recruiting
Feasibility Study on the Use of a Walking Exoskeleton in the Intensive Care Unit
Neuromuscular Disease in Post-Intensive Care Syndrome

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, PhD, FCCM 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 Critical Illness, 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 1 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 Mar 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 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 30 Mar 2020). 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?

Perfused Boundary Region (PBR) in One Week (time frame: One week on ICU). 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 NCT03146585.

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 Mar 2020.