NCT05710315

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 32 (estimated)
• Sponsor: Inova Health Care Services · Academic / Other
• Sex: All
• Age: 18 Years – 89 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a double-blind, placebo-controlled, parallel design study. A total of 32 adult patients who have been admitted to the Surgical or Medical Intensive Care Unit with evidence of MOF (defined as requiring mechanical ventilation and demonstrating at least one more system failure on the SOFA score on the day of ICU admission) and who have not yet been initiated on enteral nutrition or were initiated on enteral nutrition up to 48 hours prior. After informed consent has been obtained, two patients will receive enteral formula administered through RELiZORB™ as test subjects (will be excluded from analysis). Subsequently, patients will be randomized to RELiZORB™ vs placebo cartridges in a 1:1 ratio. Enteral nutrition will be administered through RELiZORB™ cartridges (up to 6 cartridges per day depending on the volume of enteral nutrition). Patients will be studied for a total of 5 days (considered to be the end of study). Patients will return to the original form of nutritional support per their routine clinical care.

Conditions

• Multi Organ Failure
• Exocrine Pancreatic Insufficiency

Interventions

Type	Name	Description
DEVICE	RELiZORB™	RELiZORB cartridges will be used with routine enteral feedings for 5 days for randomized participants
OTHER	Placebo	Placebo cartridges will be used with routine enteral feedings for 5 days for randomized participants

Timeline

• Start date: 2025-05-07
• Primary completion: 2026-05-31
• Completion: 2026-05-31
• First posted: 2023-02-02
• Last updated: 2026-02-04

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study