Nutritional Supplement for Patients With Severe Infection (NUWISE)
Primary Purpose
Severe Infection
Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Lauric Acid and Berberine
Sponsored by
About this trial
This is an interventional treatment trial for Severe Infection focused on measuring dyslipidemia
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
Sites / Locations
- St Paul's HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Lauric Acid and Berberine
No-intervention
Arm Description
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
participants in this arm will receive no additional intervention, beyond standard of care
Outcomes
Primary Outcome Measures
Plasma HDL
Maximum Plasma Concentration [Cmax] HDL (mmol)
Secondary Outcome Measures
WBC
Absolute count (cells per microliter)
Cytokines
Maximum Plasma Concentration [Cmax] plasma IL-6, IL-8, IL-10
28-day survival
28-day survival
Full Information
NCT ID
NCT05602324
First Posted
October 26, 2022
Last Updated
October 31, 2022
Sponsor
University of British Columbia
1. Study Identification
Unique Protocol Identification Number
NCT05602324
Brief Title
Nutritional Supplement for Patients With Severe Infection
Acronym
NUWISE
Official Title
Nutritional Supplement for Patients With Severe Infection
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 1, 2021 (Actual)
Primary Completion Date
April 2023 (Anticipated)
Study Completion Date
September 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of British Columbia
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Severe Infection
Keywords
dyslipidemia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
48 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Lauric Acid and Berberine
Arm Type
Experimental
Arm Description
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
Arm Title
No-intervention
Arm Type
No Intervention
Arm Description
participants in this arm will receive no additional intervention, beyond standard of care
Intervention Type
Dietary Supplement
Intervention Name(s)
Lauric Acid and Berberine
Intervention Description
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
Primary Outcome Measure Information:
Title
Plasma HDL
Description
Maximum Plasma Concentration [Cmax] HDL (mmol)
Time Frame
14 days
Secondary Outcome Measure Information:
Title
WBC
Description
Absolute count (cells per microliter)
Time Frame
14 days
Title
Cytokines
Description
Maximum Plasma Concentration [Cmax] plasma IL-6, IL-8, IL-10
Time Frame
14 days
Title
28-day survival
Description
28-day survival
Time Frame
28 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Lynda Lazosky
Phone
778-389-9074
Email
llazosky@providencehealth.bc.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Niki Boyd, PhD
Email
boyd.niki@gmail.com
Facility Information:
Facility Name
St Paul's Hospital
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
v6k 2a8
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
john boyd
Phone
6047106713
Email
john.boyd@hli.ubc.ca
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
we are in the process of developing a plan to share data from this study
Learn more about this trial
Nutritional Supplement for Patients With Severe Infection
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