Evaluating the Utility of RELiZORB™ for Treating Feeding Intolerance in Critically Ill Adults With Multi-Organ Failure
Single-center, Proof of Concept, Prospective Study Evaluating the Utility of RELiZORB™ for the Treatment of Feeding Intolerance in Critically Ill Adults With Multi-Organ Failure
Inova Health Care Services
32 participants
May 7, 2025
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria4
- Male or female patients aged 18 - 89 years of age.
- Patients who have Multi-Organ Failure (MOF) (defined as requiring mechanical ventilation and demonstrating at least one more system failure on the SOFA score on the day of ICU admission).
- Patients who have not yet been initiated on enteral nutrition, yet enteral nutritional support is needed, or patients who have been initiated on enteral nutrition within the previous 48 hours. Enteral nutrition support defined as support planned to be given via any route connected to the gastrointestinal system (i.e., the enteral route). This includes tube feeding using nasogastric, nasoduodenal, gastrostomy, jejunostomy tubes, or similar.
- Patients who lack the capacity to consent for themselves may be included upon receiving consent from their legally authorized representatives.
Exclusion Criteria7
- Pregnant women and prisoners.
- Hypotension is attributed to suspected or confirmed cardiogenic shock.
- Evidence of unresolved intestinal obstruction, ischemia, bleeding, perforation, fistulas or tract discontinuity, or other contraindication for enteral nutrition.
- Sepsis suspected or confirmed due to an abdominal source and enteral nutrition is contraindicated.
- C. Difficile or other gastrointestinal infection that may manifest with diarrhea.
- Use of pancreatic hormone stimulant or inhibitor (e.g. octreotide, pancreatic enzyme supplements) during or immediately prior to hospital admission.
- Any other reason that the treating or investigator team considers to be a contraindication to enteral nutrition.
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Interventions
RELiZORB cartridges will be used with routine enteral feedings for 5 days for randomized participants
Placebo cartridges will be used with routine enteral feedings for 5 days for randomized participants
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT05710315