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

NCT05710315 | Recruiting FDA Device

• 1 other identifier: INOVA-2023-42
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

Conditions

Multi Organ Failure; Exocrine Pancreatic Insufficiency

Keywords

Multi Organ Failure

Outcome Measures

Primary Outcomes (1)

• Efficacy of RELiZORB™ in Enteral Nutrition Tolerance in Critically Ill Adults with Multiple Organ Failure Over Five 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

  Duration of intervention (5 days)

Secondary Outcomes (3)

• Number of intolerance-related enteral nutrition pauses

  Duration of intervention (5 days)

• Insulin units used

  Duration of intervention (5 days)

• Change in fecal elastase

  From Baseline to end of intervention at 5 days

Study Arms (2)

RELiZORB

EXPERIMENTAL

RELiZORB™ cartridges connect in-line with existing enteral feeding pump tubing sets and patient extension sets or enteral feeding tubes.

Device: RELiZORB™

Placebo

PLACEBO COMPARATOR

Placebo cartridges connect in-line with existing enteral feeding pump tubing sets and patient extension sets or enteral feeding tubes

Other: Placebo

Interventions

RELiZORB™ DEVICE

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

RELiZORB

Placebo OTHER

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

Placebo

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female patients aged 18 - 89 years of age.
• Patients who have Multi-Organ Failure (MOF) (defined as requiring mechanical ventilation and demonstrating at least one more system failure on the SOFA score on the day of ICU admission).
• Patients who have not yet been initiated on enteral nutrition, yet enteral nutritional support is needed, or patients who have been initiated on enteral nutrition within the previous 48 hours. 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 from their legally authorized representatives.

You may not qualify if:

• Pregnant women and prisoners.
• Hypotension is attributed to suspected or confirmed cardiogenic shock.
• 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.
• Use of pancreatic hormone stimulant or inhibitor (e.g. octreotide, pancreatic enzyme supplements) during or immediately prior to hospital admission.
• Any other reason that the treating or investigator team considers to be a contraindication to enteral nutrition.

Sponsors & Collaborators

• Inova Health Care Services: lead
• Alcresta Therapeutics, Inc.: collaborator

Study Sites (1)

Inova Fairfax Medical Campus

Falls Church, Virginia, 22042, United States

RECRUITING

Related Publications (21)

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MeSH Terms

Conditions

Multiple Organ Failure; Exocrine Pancreatic Insufficiency

Condition Hierarchy (Ancestors)

Shock; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pancreatic Diseases; Digestive System Diseases

Study Officials

• George Kasotakis, MD MPH

  Inova Fairfax Medical Campus

  PRINCIPAL INVESTIGATOR

Central Study Contacts

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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 Record Dates

• First Submitted: January 24, 2023
• First Posted: February 2, 2023
• Study Start: May 7, 2025
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): May 31, 2026
• Last Updated: February 4, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)