Enhanced Nutritional Optimization in LVAD Trial
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorColumbia University
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
age >18 years
hospitalized
undergoing LVAD therapy (enrolled at time of acceptance)
Disqualifiers
intubated
congenital heart disease
infiltrative cardiomyopathy
unable to tolerate oral nutrition
Trial design
Design model
Parallel
Treatments tested in this trial
Ensure Surgery Immunonutrition shake
Dietary supplementNutrition shake to support immune health and recovery from surgery.
Treatment groups
50 Participants
are divided into 3 treatment groupsGroup A: Group 1 (Not malnourished) - 3 products per dayExperimental treatment 1 intervention
Group B: Group 1 (Not malnourished) - 1 product per dayExperimental treatment 1 intervention
Group C: Group 2 (at risk/malnourished)Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Change in Alpha Diversity (Baseline and Day 5)
Change in alpha diversity (a measure of microbiome diversity applicable to a single sample) in collected stool samples.
Time frame
Baseline and Day 52
Change in Alpha Diversity (Baseline and Pre-VAD)
Change in alpha diversity (a measure of microbiome diversity applicable to a single sample) in collected stool samples.
Time frame
Baseline and Pre-VAD (approximately Day 0-5)3
Change in Alpha Diversity (Baseline and Discharge)
Change in alpha diversity (a measure of microbiome diversity applicable to a single sample) in collected stool samples.
Time frame
Baseline and Discharge (approximately Day 25)4
Change in Alpha Diversity (Baseline and Post-Discharge Follow-up)
Change in alpha diversity (a measure of microbiome diversity applicable to a single sample) in collected stool samples.
Time frame
Baseline and Post-Discharge Follow-up (approximately Day 55)Secondary outcomes
1
Post-LVAD Infections
Number and type of infections experienced during index hospitalization following LVAD implantation
Time frame
Day 252
Post-LVAD Length of Stay in intensive care unit
Number of days spent in intensive care unit following LVAD implantation.
Time frame
Day 253
Post-LVAD Mortality
Number of participant deaths.
Time frame
Up to 2 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Columbia University
Lead sponsor
Abbott Nutrition
Collaborator
Source ClinicalTrials.gov