Glycocalyx Damage in Critically Ill Patients

NCT ID: NCT03146585

Last Updated: 2020-03-30

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

40 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-11-01

Study Completion Date

2018-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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Critical Illness

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients on artificial ventilation

PBR assessment

Intervention Type DEVICE

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

Patients on renal replacement therapy

PBR assessment

Intervention Type DEVICE

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

Patients with targeted temperature management

PBR assessment

Intervention Type DEVICE

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

Interventions

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PBR assessment

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

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* pregnant women
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital Hradec Kralove

OTHER

Sponsor Role lead

Responsible Party

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Vladimir Cerny

Clinical Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Vladimir Cerny, MD, PhD, FCCM

Role: PRINCIPAL_INVESTIGATOR

University Hospital Hradec Kralove

Locations

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University Hospital Hradec Kralove

Hradec Králové, Třebeš, Czechia

Site Status

Countries

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Czechia

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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AZVCR 9307_3

Identifier Type: -

Identifier Source: org_study_id

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