Enhanced Nutritional Optimization in LVAD (ENOL) Trial

Status: Recruiting
Location: See location...
Intervention Type: Dietary supplement
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

The goal of this clinical trial is to assess whether a peri-operative intervention with nutritional immune modulating intervention (Ensure Surgery Immunonutrition shake) has beneficial effects on the complex interplay between gut microbiome, systemic inflammation and malnutrition that is commonly present in advanced heart failure and the adverse events associated with left ventricular assist device (LVAD) placement in hospitalized advanced heart failure patients awaiting LVAD implantation. The main questions it aims to answer are: * Will pre-surgical supplementation with Ensure Surgery affect gut microbial composition and levels of inflammation among heart failure patients undergoing LVAD implantation? * Will pre-surgical supplementation with Ensure Surgery affect post-surgical morbidity (e.g., infections, intensive care unit length of stay (LOS)) and mortality? Participants will be evaluated for malnutrition and will be given Ensure Surgery Immunonutrition shake to drink in the days preceding their LVAD surgery. Blood and stool samples will be collected at prespecified timepoints before and after surgery. Researchers will compare malnourished participants drinking Ensure Surgery 3/day with well-nourished participants randomized to drink either 1/day or 3/day to see if any of the above supplementation strategies change the gut microbial composition, levels of inflammation, and post-surgical morbidity and mortality.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• age \>18 years

• hospitalized

• undergoing LVAD therapy (enrolled at time of acceptance)

Locations
United States
New York
Columbia University Medical Center
RECRUITING
New York
Contact Information
Primary
Melana Yuzefpolskaya, MD
my2249@cumc.columbia.edu
3472681454
Backup
Annamaria Ladanyi, MD
al4285@cumc.columbia.edu
3322177467
Time Frame
Start Date: 2022-09-22
Estimated Completion Date: 2026-01
Participants
Target number of participants: 50
Treatments
Experimental: Group 1 (Not malnourished) - 3 products per day
Patients assessed as well-nourished based on AND-ASPEN criteria and randomized to receive 3 Ensure Surgery Immunonutrition shake per day during the days from consent to LVAD implantation.
Experimental: Group 1 (Not malnourished) - 1 product per day
Patients assessed as well-nourished based on AND-ASPEN criteria and randomized to receive 1 Ensure Surgery Immunonutrition shake per day during the days from consent to LVAD implantation.
Experimental: Group 2 (at risk/malnourished)
Patients assessed as at risk for malnourishment or malnourished based on AND-ASPEN criteria automatically assigned to receive 3 Ensure Surgery Immunonutrition shake per day during the days from consent to LVAD implantation.
Related Therapeutic Areas
Sponsors
Leads: Columbia University
Collaborators: Abbott Nutrition

This content was sourced from clinicaltrials.gov