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NCT03146585

Glycocalyx Damage in Critically Ill Patients

Completed Results posted Last updated 30 March 2020
What this trial tests

trial testing PBR assessment in Critical Illness in 40 participants. Completed in 30 June 2018.

Timeline
1 November 2015
Primary endpoint
31 December 2017
30 June 2018

Quick facts

Lead sponsorUniversity Hospital Hradec Kralove
StatusCompleted
Study typeOBSERVATIONAL
Enrollment40
Start date1 November 2015
Primary completion31 December 2017
Estimated completion30 June 2018
Sites1 location across Czechia

Drugs / interventions tested

Conditions studied

Sponsor

University Hospital Hradec Kralove

Who can join

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 Week Primary · One week on ICU

PBR is an indirect measure of assessment of the endothelial glycocalyx thickness in sublingual microcirculation.

GroupValue95% CI
Patients on Artificial Ventilation1.951.77 – 2.12
Patients on Renal Replacement Therapy1.971.75 – 2.12
Patients With Targeted Temperature Management2.021.71 – 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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Other recruiting trials for Critical Illness

Currently open trials in the same condition.

Other University Hospital Hradec Kralove trials

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Data sources for this page

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.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing