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
Inova Health Care Services
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.
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 with evidence of MOF (defined as requiring mechanical ventilation and demonstrating at least one more system failure on the SOFA score on the day of ICU admission) and who have not yet been initiated on enteral nutrition or were initiated on enteral nutrition up to 48 hours prior. After informed consent has been obtained, two patients will receive enteral formula administered through RELiZORB™ as test subjects (will be excluded f…
Eligibility
- Age range
- 18–89 years
- Sex
- All
- Healthy volunteers
- No
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 ro…
Interventions
- DeviceRELiZORB™
RELiZORB cartridges will be used with routine enteral feedings for 5 days for randomized participants
- OtherPlacebo
Placebo cartridges will be used with routine enteral feedings for 5 days for randomized participants
Location
- Inova Fairfax Medical CampusFalls Church, Virginia