Nutritional Supplement for Patients With Severe Infection
- 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
- Clinical diagnosis of Sepsis
- plasma high density lipoprotein levels less than 1 mM
- receiving enteral nutrition
• known pregnancy/intending to get pregnant within 28 days of enrollment in study
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method Plasma HDL 14 days Maximum Plasma Concentration \[Cmax\] HDL (mmol)
- Secondary Outcome Measures
Name Time Method WBC 14 days Absolute count (cells per microliter)
Cytokines 14 days Maximum Plasma Concentration \[Cmax\] plasma IL-6, IL-8, IL-10
28-day survival 28 days 28-day survival
Trial Locations
- Locations (1)
St Paul's Hospital
🇨🇦Vancouver, British Columbia, Canada
St Paul's Hospital🇨🇦Vancouver, British Columbia, Canadajohn boydContact6047106713john.boyd@hli.ubc.ca