MedPath

Nutritional Supplement for Patients With Severe Infection

Not Applicable
Recruiting
Conditions
Severe Infection
Registration Number
NCT05602324
Lead Sponsor
University of British Columbia
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
RECRUITING
Sex
All
Target Recruitment
48
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Primary Outcome Measures
NameTimeMethod
Plasma HDL14 days

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

Secondary Outcome Measures
NameTimeMethod
WBC14 days

Absolute count (cells per microliter)

Cytokines14 days

Maximum Plasma Concentration \[Cmax\] plasma IL-6, IL-8, IL-10

28-day survival28 days

28-day survival

Trial Locations

Locations (1)

St Paul's Hospital

🇨🇦

Vancouver, British Columbia, Canada

St Paul's Hospital
🇨🇦Vancouver, British Columbia, Canada
john boyd
Contact
6047106713
john.boyd@hli.ubc.ca

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