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

Not Applicable

Recruiting

• Conditions: Multi Organ Failure; Exocrine Pancreatic Insufficiency
• Interventions: Drug: Relizorb; Other: Placebo

• Registration Number: NCT05710315
• Lead Sponsor: Inova Health Care Services

Brief 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 over the previous 72 hours with evidence of MOF (defined as requiring inotropic/vasopressor support and mechanical ventilation) and who have not yet been initiated on enteral nutrition.

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.

Study Timeline

• Study First Submitted: 2023-01-24
• Study First Submitted QC: 2023-01-24
• Study First Posted: 2023-02-02
• Status Verified: 2025-05
• Study Start: 2025-05-07
• Last Update Submitted: 2025-05-21
• Last Update Posted: 2025-05-25
• Primary Completion: 2026-03-02
• Study Completion: 2026-03-02

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 32

Inclusion 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.

Exclusion Criteria

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
ReliZORB	Relizorb	ReliZORB enzyme cartridges will be used with enteral feedings for 5 days
Placebo	Placebo	Placebo enzyme cartridges will be used with enteral feedings for 5 days

Primary Outcome Measures

Name	Time	Method
Efficacy of RELiZORB™ in Enteral Nutrition Tolerance in Critically Ill Adults with Multiple Organ Failure Over Five Days	Duration of intervention (5 days)	Efficacy will be assessed by the total calories administered, expressed as the percentage of goal nutrition calories achieved daily, compared between the two groups over the five-day study period

Secondary Outcome Measures

Name	Time	Method
Number of intolerance-related enteral nutrition pauses	Duration of intervention (5 days)	The number of unplanned enteral nutrition pauses due to enteral nutrition intolerance
Insulin units used	Duration of intervention (5 days)	Insulin units used
Change in fecal elastase	From Baseline to end of intervention at 5 days	Change in fecal elastase as a measure of clinical exocrine pancreatic insufficiency

Trial Locations

Locations (1)

Inova Fairfax Medical Campus; 🇺🇸 Falls Church, Virginia, United States