Using RELiZORB™ to improve nutrition 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

This study is testing if a new digestive enzyme cartridge called RELiZORB™ can help critically ill adults with multi-organ failure better tolerate nutrition through feeding tubes.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 32 (estimated)
• Ages: 18 Years to 89 Years
• Sex: All
• Sponsor: Inova Health Care Services (Academic / other)
• Locations: 1 site (Falls Church, Virginia)
• Trial ID: NCT05710315 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to evaluate the effectiveness of RELiZORB™, a digestive enzyme cartridge, in enhancing nutrition tolerance for critically ill adults suffering from multi-organ failure. The study involves a double-blind, placebo-controlled design where patients will be randomized to receive either RELiZORB™ or a placebo while receiving enteral nutrition. Participants will be monitored for 5 days to assess their nutritional goals and overall health outcomes. The trial is conducted at Inova Fairfax Medical Campus and includes patients who have not yet started enteral nutrition.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-89 with multi-organ failure requiring inotropic support and mechanical ventilation who have not yet begun enteral nutrition.

Not a fit: Patients who are pregnant, prisoners, or those with conditions like cardiogenic shock or moribund status may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly improve nutritional support and recovery for critically ill patients with multi-organ failure.

How similar studies have performed: While the use of RELiZORB™ is FDA-approved for tube feedings, its application in multi-organ failure is not standard practice, making this a novel approach.

Eligibility criteria

Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Where this trial is running

Falls Church, Virginia

• Inova Fairfax Medical Campus — Falls Church, Virginia, United States (Recruiting)

Study contacts

• Principal investigator: George Kasotakis, MD MPH — Inova Fairfax Medical Campus
• Study coordinator: George J Kasotakis, MD MPH

Conditions Multi Organ Failure; Exocrine Pancreatic Insufficiency