CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 40 enrolled
Drug / intervention
PBR assessmentdevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03146585
NCT03146585N/ACompleted

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

University Hospital Hradec Kralove·observational·Posted May 10, 2017·Updated Mar 30, 2020

In Brief

An observational study evaluating PBR assessment for Critical Illness. Completed, enrolled 40 participants across 1 site.

Detailed 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. 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesCzechia
Collaborators--

Timeline

N/ACompletedFinished
20162017201820192020202120222023202420252026
First PostedMay 10, 2017
Enrollment StartNov 1, 2015
Primary CompletionDec 31, 2017
Study CompletionJun 30, 2018
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 9.1 years ago

Interventions

PBR assessmentdevice

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