Trial Outcomes & Findings for Evaluation of Lipid Emulsion on GCX in Critically Ill Patients (NCT NCT03216850)

NCT ID: NCT03216850

Last Updated: 2019-11-27

Results Overview

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.

• Recruitment status: COMPLETED
• Target enrollment: 15 participants
• Primary outcome timeframe: One week within the ICU care
• Results posted on: 2019-11-27

Participant Flow

Participant milestones

Measure	Patients in ICU Requiring Parenteral Nutrition Sublingual microcirculation assessment: Non-invasive investigation of the endothelial glycocalyx in the sublingual microcirculation.
Overall Study STARTED	15
Overall Study COMPLETED	9
Overall Study NOT COMPLETED	6

Reasons for withdrawal

Measure	Patients in ICU Requiring Parenteral Nutrition Sublingual microcirculation assessment: Non-invasive investigation of the endothelial glycocalyx in the sublingual microcirculation.
Overall Study Pre-analytical error	6

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Patients in ICU Requiring Parenteral Nutrition n=15 Participants Sublingual microcirculation assessment: Non-invasive investigation of the endothelial glycocalyx in the sublingual microcirculation.
Age, Categorical <=18 years	0 Participants n=15 Participants
Age, Categorical Between 18 and 65 years	15 Participants n=15 Participants
Age, Categorical >=65 years	0 Participants n=15 Participants
Age, Continuous	64 years STANDARD_DEVIATION 12 • n=15 Participants
Sex: Female, Male Female	8 Participants n=15 Participants
Sex: Female, Male Male	7 Participants n=15 Participants
Region of Enrollment Czechia	15 participants n=15 Participants
PBR value	2.10 micrometer n=15 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Patients in ICU Requiring Parenteral Nutrition n=9 Participants Sublingual microcirculation assessment: Non-invasive investigation of the endothelial glycocalyx in the sublingual microcirculation.
Endothelial Glycocalyx Thickness	2.28 micrometer Interval 2.11 to 2.45

Adverse Events

Patients in ICU Requiring Parenteral Nutrition

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. David Astapenko

University Hospital Hradec Kralove

Phone: +420495833218

Email: astapenko.d@seznam.cz

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place