RecruitingNot ApplicableNCT05710315

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


Sponsor

Inova Health Care Services

Enrollment

32 participants

Start Date

May 7, 2025

Study Type

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

Min Age: 18 YearsMax Age: 89 Years

Plain Language Summary

Simplified for easier understanding

This study tests a device called RELiZORB — an enzyme cartridge attached to feeding tubes — in critically ill adults with multi-organ failure (MOF). Many ICU patients cannot digest fats well due to their critical illness, leading to poor nutrition even when tube feeding is provided. RELiZORB breaks down fats in the feeding formula before they reach the gut, which may improve calorie absorption and nutritional outcomes for very ill patients. You may be eligible if: - You are between 18 and 89 years old - You are in the ICU with multi-organ failure (requiring mechanical ventilation plus at least one other organ failure) - You have not yet started tube feeding or started within the past 48 hours - If you cannot consent yourself, a legally authorized representative may consent on your behalf You may NOT be eligible if: - You are pregnant or a prisoner - You have low blood pressure due to suspected cardiogenic shock - You have an intestinal obstruction, ischemia, bleeding, perforation, fistula, or other contraindication to tube feeding - Your sepsis is suspected to originate from an abdominal source and tube feeding is contraindicated - You have a C. diff or other gastrointestinal infection with diarrhea - You are taking pancreatic enzyme supplements or hormones (e.g., octreotide) - The treating team has another reason to avoid tube feeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICERELiZORB™

RELiZORB cartridges will be used with routine enteral feedings for 5 days for randomized participants

OTHERPlacebo

Placebo cartridges will be used with routine enteral feedings for 5 days for randomized participants


Locations(1)

Inova Fairfax Medical Campus

Falls Church, Virginia, United States

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NCT05710315


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