RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2025-05-07
Study Completion:2026-03-02
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05710315

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.

Ages Eligible for Study:18 Years to 89 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Male or female patients aged 18 - 89 years of age.
  2. * Patients who have Multi-Organ Failure (MOF) (defined as requiring inotropic/vasopressor support and mechanical ventilation).
  3. * 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.
  4. * Patients who lack the capacity to consent for themselves may be included upon receiving consent form their legally authorized representatives.
  1. * Pregnant women and prisoners.
  2. * Hypotension is attributed to suspected or confirmed cardiogenic shock.
  3. * Moribund patients (expected to expire within 120 hours).
  4. * Evidence of unresolved intestinal obstruction, ischemia, bleeding, perforation, fistulas or tract discontinuity, or other contraindication for enteral nutrition.
  5. * Sepsis suspected or confirmed due to an abdominal source and enteral nutrition is contraindicated.
  6. * C. Difficile or other gastrointestinal infection that may manifest with diarrhea.
  7. * Constipation as a pre-existing comorbidity (defined as laxative or stool softener use prior to admission to the hospital).
  8. * Use of pancreatic hormone stimulant or inhibitor (e.g. octreotide, pancreatic enzyme supplements) during or immediately prior to hospital admission.
  9. * Use of parenteral nutrition.
  10. * Patients receiving cancer-related treatment in the last 6 months.
  11. * Any other reason that the treating or investigator team considers to be a contraindication to enteral nutrition.

Contacts and Locations

Study Contact

George J Kasotakis, MD MPH
CONTACT
(703) 776-2274
George.Kasotakis@inova.org
Laura E Madarasz, MS, BA
CONTACT
(703) 776-2189
laura.madarasz@inova.org

Principal Investigator

George Kasotakis, MD MPH
PRINCIPAL_INVESTIGATOR
Inova Fairfax Medical Campus

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: Inova Health Care Services

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-05-07
Study Completion Date2026-03-02

Study Record Updates

Study Start Date2025-05-07
Study Completion Date2026-03-02

Terms related to this study

Keywords Provided by Researchers

  • Multi Organ Failure

Additional Relevant MeSH Terms

  • Multi Organ Failure
  • Exocrine Pancreatic Insufficiency