Skip to main content
Clinical Trials/NCT05602324
NCT05602324
Recruiting
Not Applicable

Nutritional Supplement for Patients With Severe Infection

University of British Columbia1 site in 1 country48 target enrollmentOctober 1, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Severe Infection
Sponsor
University of British Columbia
Enrollment
48
Locations
1
Primary Endpoint
Plasma HDL
Status
Recruiting
Last Updated
3 years ago

Overview

Brief Summary

This is a randomized trial testing a supplement that has been approved by Health Canada to support healthy cholesterol levels (i.e. high density lipoprotein (HDL) cholesterol). This trial is proposing to use this approved supplement to determine whether it is able to raise HDL cholesterol in patients treated in the intensive care unit (ICU) with severe infection who have detrimentally low levels of HDL cholesterol. Patients who present to the ICU with severe infection will be approached for consent. If they choose to participate, patients will be given usual care or a 150mL daily nutritional supplement containing lauric acid (15 ml) and Berberine (1000 mg) daily for 14 days. Participants will be followed during their stay in the ICU and will receive follow up phone calls at Day 28 and 90.

Registry
clinicaltrials.gov
Start Date
October 1, 2021
End Date
September 2023
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

john boyd

Associate Professor

University of British Columbia

Eligibility Criteria

Inclusion Criteria

  • Clinical diagnosis of Sepsis
  • plasma high density lipoprotein levels less than 1 mM
  • receiving enteral nutrition

Exclusion Criteria

  • known pregnancy/intending to get pregnant within 28 days of enrollment in study

Outcomes

Primary Outcomes

Plasma HDL

Time Frame: 14 days

Maximum Plasma Concentration \[Cmax\] HDL (mmol)

Secondary Outcomes

  • WBC(14 days)
  • Cytokines(14 days)
  • 28-day survival(28 days)

Study Sites (1)

Loading locations...

Similar Trials