Nutritional Supplement for Patients With Severe Infection

Study 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.

Official Title
-----------------
Nutritional Supplement for Patients With Severe Infection

Conditions
-----------------
Severe Infection

Intervention / Treatment
-----------------
* Dietary Supplement: Lauric Acid and Berberine


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 19 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lauric Acid and Berberine<br>Participants in this arm of the trial will receive 15 ml lauric acid and 1000 mg berberine daily (via feed tube) for the duration of time that they are receiving enteral feeding, up to a maximum time of 14 days | Dietary Supplement: Lauric Acid and Berberine<br>* intervention (15 ml lauric acid + 1000 mg berberine) will be provided daily to participants in this arm for the duration of time that they receive enteral nutrition for a period of 14 days maximum<br>|
| No Intervention: No-intervention<br>participants in this arm will receive no additional intervention, beyond standard of care | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma HDL | Maximum Plasma Concentration [Cmax] HDL (mmol) | 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| WBC | Absolute count (cells per microliter) | 14 days | 
| Cytokines | Maximum Plasma Concentration [Cmax] plasma IL-6, IL-8, IL-10 | 14 days | 
| 28-day survival | 28-day survival | 28 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
dyslipidemia