18 and older, any sex, with Critical Illness. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Perfused Boundary Region (PBR) in One WeekPrimary· One week on ICU
PBR is an indirect measure of assessment of the endothelial glycocalyx thickness in sublingual microcirculation.
Group
Value
95% CI
Patients on Artificial Ventilation
1.95
1.77 – 2.12
Patients on Renal Replacement Therapy
1.97
1.75 – 2.12
Patients With Targeted Temperature Management
2.02
1.71 – 2.15
Sponsor's own description
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.
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
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Sponsor: as reported to ClinicalTrials.gov by University Hospital Hradec Kralove
Last refreshed: 30 March 2020
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03146585.