Trial Outcomes & Findings for Glycocalyx Damage in Critically Ill Patients (NCT NCT03146585)
NCT ID: NCT03146585
Last Updated: 2020-03-30
Results Overview
PBR is an indirect measure of assessment of the endothelial glycocalyx thickness in sublingual microcirculation.
Recruitment status
COMPLETED
Target enrollment
40 participants
Primary outcome timeframe
One week on ICU
Results posted on
2020-03-30
Participant Flow
Adult patients admitted to our ICU with any kind of organ support.
Participant milestones
| Measure |
Patients on Artificial Ventilation
PBR assessment: Sublingual microcirculation will be investigated by specialized handheld videomicroscopy device for PBR index.
|
Patients on Renal Replacement Therapy
PBR assessment: Sublingual microcirculation will be investigated by specialized handheld videomicroscopy device for PBR index.
|
Patients With Targeted Temperature Management
PBR assessment: Sublingual microcirculation will be investigated by specialized handheld videomicroscopy device for PBR index.
|
|---|---|---|---|
|
Overall Study
STARTED
|
25
|
10
|
5
|
|
Overall Study
COMPLETED
|
25
|
10
|
5
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Patients on Artificial Ventilation
n=25 Participants
PBR assessment: Sublingual microcirculation will be investigated by specialized handheld videomicroscopy device for PBR index.
|
Patients on Renal Replacement Therapy
n=10 Participants
PBR assessment: Sublingual microcirculation will be investigated by specialized handheld videomicroscopy device for PBR index.
|
Patients With Targeted Temperature Management
n=5 Participants
PBR assessment: Sublingual microcirculation will be investigated by specialized handheld videomicroscopy device for PBR index.
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=25 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=40 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
25 Participants
n=25 Participants
|
10 Participants
n=10 Participants
|
5 Participants
n=5 Participants
|
40 Participants
n=40 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=25 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=40 Participants
|
|
Age, Continuous
|
45 years
STANDARD_DEVIATION 5 • n=25 Participants
|
50 years
STANDARD_DEVIATION 6 • n=10 Participants
|
62 years
STANDARD_DEVIATION 3 • n=5 Participants
|
60 years
STANDARD_DEVIATION 5 • n=40 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=25 Participants
|
3 Participants
n=10 Participants
|
2 Participants
n=5 Participants
|
15 Participants
n=40 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=25 Participants
|
7 Participants
n=10 Participants
|
3 Participants
n=5 Participants
|
25 Participants
n=40 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Czechia
|
25 Participants
n=25 Participants
|
10 Participants
n=10 Participants
|
5 Participants
n=5 Participants
|
40 Participants
n=40 Participants
|
|
PBR value
|
2.02 micrometer
n=25 Participants
|
2.13 micrometer
n=10 Participants
|
2.07 micrometer
n=5 Participants
|
2.10 micrometer
n=40 Participants
|
PRIMARY outcome
Timeframe: One week on ICUPBR is an indirect measure of assessment of the endothelial glycocalyx thickness in sublingual microcirculation.
Outcome measures
| Measure |
Patients on Artificial Ventilation
n=25 Participants
PBR assessment: Sublingual microcirculation will be investigated by specialized handheld videomicroscopy device for PBR index.
|
Patients on Renal Replacement Therapy
n=10 Participants
PBR assessment: Sublingual microcirculation will be investigated by specialized handheld videomicroscopy device for PBR index.
|
Patients With Targeted Temperature Management
n=5 Participants
PBR assessment: Sublingual microcirculation will be investigated by specialized handheld videomicroscopy device for PBR index.
|
|---|---|---|---|
|
Perfused Boundary Region (PBR) in One Week
|
1.95 micrometer
Interval 1.77 to 2.12
|
1.97 micrometer
Interval 1.75 to 2.12
|
2.02 micrometer
Interval 1.71 to 2.15
|
Adverse Events
Patients on Artificial Ventilation
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Patients on Renal Replacement Therapy
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Patients With Targeted Temperature Management
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Dr. David Astapenko
University Hospital Hradec Kralove
Phone: +420608177374
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place