Evaluation of Lipid Emulsion on GCX in Critically Ill Patients

NCT ID: NCT03216850

Last Updated: 2019-11-27

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

15 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-01-01

Study Completion Date

2018-12-31

Brief Summary

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Characterisation of the lipidome and parenteral nutrition modulate the endothelial glycocalyx.

The aim of the study A is to detect any influence of the lipid emulsion on the endothelial glycocalyx in patients in critical care. The targeted cohort is patients on ICU with an indication for parenteral nutrition including lipid emulsion. 15 patients are planned to be enrolled.

Monitored variables: demographic data, type of the population, type of the lipid emulsion, selected variables of the lipid metabolism, sublingual microcirculation (SDF imaging),

Detailed Description

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Conditions

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Endothelial Dysfunction

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients in ICU requiring parenteral nutrition

Sublingual microcirculation assessment

Intervention Type DEVICE

Non-invasive investigation of the endothelial glycocalyx in the sublingual microcirculation.

Interventions

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Sublingual microcirculation assessment

Non-invasive investigation of the endothelial glycocalyx in the sublingual microcirculation.

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* patients in ICU
* indication for lipid administration as a part of TPN

Exclusion Criteria

* shock or clinical/laboratory signs of tissue hypoperfusion
* previous lipid infusions (within 3 months before entering study)
* hyperlipidaemia
* hyperglycaemia (over 10 mmol/l)
* current or previous (within 72 hours before entering the study) use of propofol
* pancreatitis
* severe liver failure
* current use of statins
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

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_5/a

Identifier Type: -

Identifier Source: org_study_id

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