Evaluating the Utility of RELiZORB™ for Treating Feeding Intolerance in Critically Ill Adults With Multi-Organ Failure

Description

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

Multi Organ Failure, Exocrine Pancreatic Insufficiency

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Study Overview

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Study Details

Study overview

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.

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

Evaluating the Utility of RELiZORB™ for Treating Feeding Intolerance in Critically Ill Adults With Multi-Organ Failure

Condition
Multi Organ Failure
Intervention / Treatment

-

Contacts and Locations

Falls Church

Inova Fairfax Medical Campus, Falls Church, Virginia, United States, 22042

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Male or female patients aged 18 - 89 years of age.
  • * Patients who have Multi-Organ Failure (MOF) (defined as requiring inotropic/vasopressor support and mechanical ventilation).
  • * Patients who have not yet been initiated on enteral nutrition, yet enteral nutritional support is needed. 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 form their legally authorized representatives.
  • * Pregnant women and prisoners.
  • * Hypotension is attributed to suspected or confirmed cardiogenic shock.
  • * Moribund patients (expected to expire within 120 hours).
  • * 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.
  • * Constipation as a pre-existing comorbidity (defined as laxative or stool softener use prior to admission to the hospital).
  • * Use of pancreatic hormone stimulant or inhibitor (e.g. octreotide, pancreatic enzyme supplements) during or immediately prior to hospital admission.
  • * Use of parenteral nutrition.
  • * Patients receiving cancer-related treatment in the last 6 months.
  • * Any other reason that the treating or investigator team considers to be a contraindication to enteral nutrition.

Ages Eligible for Study

18 Years to 89 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Inova Health Care Services,

George Kasotakis, MD MPH, PRINCIPAL_INVESTIGATOR, Inova Fairfax Medical Campus

Study Record Dates

2026-03-02