Actively Recruiting
Evaluating the Utility of RELiZORB™ for Treating Feeding Intolerance in Critically Ill Adults With Multi-Organ Failure
Led by Inova Health Care Services · Updated on 2026-02-04
32
Participants Needed
1
Research Sites
55 weeks
Total Duration
On this page
Sponsors
I
Inova Health Care Services
Lead Sponsor
A
Alcresta Therapeutics, Inc.
Collaborating Sponsor
AI-Summary
What this Trial Is About
The purpose of this research is to determine if the use of RELiZORB™ improves nutrition tolerance and helps critically ill patients meet their nutrition goals. RELiZORB™ is a digestive enzyme cartridge that contains lipase and works as a pancreatic enzyme replacement. It promotes breaking down fat and helps the body absorb it. The device connects with tube feedings to help the body with digestion. RELiZORB™ is approved by the U.S. Food and Drug Administration (FDA) for use with tube feedings in patients 5 years of age or older. While the use of RELiZORB™ in this study is consistent with the FDA approval, the use of RELiZORB™ in patients with multi organ failure is not in the current standard of care practice at Inova Health Care facilities.
CONDITIONS
Official Title
Evaluating the Utility of RELiZORB™ for Treating Feeding Intolerance in Critically Ill Adults With Multi-Organ Failure
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female patients aged 18 to 89 years
- Patients with multi-organ failure requiring mechanical ventilation and at least one other organ failure on SOFA score at ICU admission
- Patients who have not started enteral nutrition yet but need it, or started enteral nutrition within the past 48 hours
- Enteral nutrition support via any gastrointestinal feeding tube (nasogastric, nasoduodenal, gastrostomy, jejunostomy, or similar)
- Patients lacking capacity to consent may be included if legally authorized representatives consent
You will not qualify if you...
- Pregnant women and prisoners
- Hypotension due to suspected or confirmed cardiogenic shock
- Unresolved intestinal obstruction, ischemia, bleeding, perforation, fistulas, or contraindications to enteral nutrition
- Suspected or confirmed abdominal source sepsis contraindicating enteral nutrition
- C. Difficile or other gastrointestinal infections causing diarrhea
- Use of pancreatic hormone stimulants or inhibitors (e.g., octreotide, pancreatic enzyme supplements) during or immediately before hospital admission
- Any other contraindication to enteral nutrition as determined by treating or investigator team
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Inova Fairfax Medical Campus
Falls Church, Virginia, United States, 22042
Actively Recruiting
Research Team
G
George J Kasotakis, MD MPH
CONTACT
L
Laura E Madarasz, MS, BA
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
DIAGNOSTIC
Number of Arms
2
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