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

Launched by INOVA HEALTH CARE SERVICES · Jan 24, 2023

Keywords

ClinConnect Summary

This clinical trial is studying a device called ReliZORB™, which helps critically ill patients with multi-organ failure better absorb nutrients from tube feedings. Many patients in this situation struggle with feeding intolerance, meaning their bodies have trouble digesting food. ReliZORB™ contains a digestive enzyme that helps break down fat, making it easier for the body to use the nutrients it needs to recover. The goal of the study is to see if using ReliZORB™ can help these patients meet their nutrition goals more effectively.

To be eligible for this trial, participants must be between 18 and 89 years old, have multi-organ failure, and need nutritional support through tube feeding. Patients must not have started their tube feedings yet. However, some individuals cannot participate, including pregnant women, those with certain severe medical conditions, or recent cancer treatments. If patients join the trial, they can expect to receive tube feedings with the ReliZORB™ device to see if it helps improve their nutrition tolerance. It's important to note that while ReliZORB™ is approved by the FDA for certain patients, its use for those with multi-organ failure is not yet a standard practice at this healthcare facility.

Gender

ALL

Eligibility criteria

• 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.