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
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.
• 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.