Evaluation of Lipid Emulsion on GCX in Critically Ill Patients

November 8, 2019 updated by: Vladimir Cerny, University Hospital Hradec Kralove

Alterations of Glycocalyx in Critical Illness and During Major Surgery and Approaches for Glycocalyx Protection. Effect of Parenteral Nutrition and Plasma Lipidome on GCX

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),

Study Overview

Status

Completed

Study Type

Observational

Enrollment (Actual)

15

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Třebeš
      • Hradec Králové, Třebeš, Czechia, 50005
        • University hospital Hradec Králové

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

All patients who meet the inclusion criteria admitted to the ICU.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients in ICU requiring parenteral nutrition
Non-invasive investigation of the endothelial glycocalyx in the sublingual microcirculation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Endothelial Glycocalyx Thickness
Time Frame: One week within the ICU care
Endothelial glycocalyx thickness was measured indirectly by PBR, which is a lateral movement of the red blood cells from the median column in the microcirculation in micrometers. The higher the PBR is the more damaged the endothelial glycocalyx is.
One week within the ICU care

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Vladimir Cerny, MD, University hospital Hradec Králové

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2018

Primary Completion (Actual)

August 31, 2018

Study Completion (Actual)

December 31, 2018

Study Registration Dates

First Submitted

July 11, 2017

First Submitted That Met QC Criteria

July 11, 2017

First Posted (Actual)

July 13, 2017

Study Record Updates

Last Update Posted (Actual)

November 27, 2019

Last Update Submitted That Met QC Criteria

November 8, 2019

Last Verified

November 1, 2019

More Information

Terms related to this study

Other Study ID Numbers

  • AZVCR 9307_5/a

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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