Glycocalyx Damage in Critically Ill Patients

NCT03146585 | Completed Results

• 1 other identifier: AZVCR 9307_3
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Critical Illness

Keywords

Glycocalyx

Outcome Measures

Primary Outcomes (1)

• Perfused Boundary Region (PBR) in One Week

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

  One week on ICU

Study Arms (3)

Patients on artificial ventilation

Device: PBR assessment

Patients on renal replacement therapy

Device: PBR assessment

Patients with targeted temperature management

Device: PBR assessment

Interventions

PBR assessment DEVICE

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

Patients on artificial ventilation; Patients on renal replacement therapy; Patients with targeted temperature management

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients admitted to ICU meeting inclusion criteria.

You may qualify if:

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

You may not qualify if:

• pregnant women

Sponsors & Collaborators

• University Hospital Hradec Kralove: lead

Study Sites (1)

University Hospital Hradec Kralove

Hradec Králové, Třebeš, 50005, Czechia

Location

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr. David Astapenko
• Organization: University Hospital Hradec Kralove

astapenko.d@seznam.cz

+420608177374

Study Officials

• Vladimir Cerny, MD, PhD, FCCM

  University Hospital Hradec Kralove

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: May 7, 2017
• First Posted: May 10, 2017
• Study Start: November 1, 2015
• Primary Completion: December 31, 2017
• Study Completion: June 30, 2018
• Last Updated: March 30, 2020
• Results First Posted: March 30, 2020

Record last verified: 2020-03

Locations

CZ (1)