Nutritional Supplement for Patients With Severe Infection
NUWISE
1 other identifier
interventional
48
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Oct 2021
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2021
CompletedFirst Submitted
Initial submission to the registry
October 26, 2022
CompletedFirst Posted
Study publicly available on registry
November 2, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2023
CompletedNovember 2, 2022
October 1, 2022
1.5 years
October 26, 2022
October 31, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Plasma HDL
Maximum Plasma Concentration \[Cmax\] HDL (mmol)
14 days
Secondary Outcomes (3)
WBC
14 days
Cytokines
14 days
28-day survival
28 days
Study Arms (2)
Lauric Acid and Berberine
EXPERIMENTALParticipants 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
No-intervention
NO INTERVENTIONparticipants in this arm will receive no additional intervention, beyond standard of care
Interventions
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
Eligibility Criteria
You may qualify if:
- Clinical diagnosis of Sepsis
- plasma high density lipoprotein levels less than 1 mM
- receiving enteral nutrition
You may not qualify if:
- known pregnancy/intending to get pregnant within 28 days of enrollment in study
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
St Paul's Hospital
Vancouver, British Columbia, v6k 2a8, Canada
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
October 26, 2022
First Posted
November 2, 2022
Study Start
October 1, 2021
Primary Completion
April 1, 2023
Study Completion
September 1, 2023
Last Updated
November 2, 2022
Record last verified: 2022-10
Data Sharing
- IPD Sharing
- Will not share
we are in the process of developing a plan to share data from this study