Single-center, Open-label, Prospective Randomized (Double-Blind) Study on the Use of ReliZORB™ for the Treatment of Feeding Intolerance in Critically Ill Adults With Multi Organ Failure

Pro00110857

The purpose of this study is to determine if the use of ReliZORB improves nutrition tolerance and helps critically ill patients meet their nutrition goals. Subjects in the intensive care unit will be enrolled and randomized 2:1 to receive ReliZORB or placebo cartridges with enteral feedings for 5 days. Blood and stool samples will be collected to test for nutrition and inflammation.

2023-05-01

2023-07-30

2024-01-30

Withdrawn

Early phase I

Inclusion Criteria: * Admission to Surgical or Medical Intensive Care Unit within 72 hours * Evidence of multi-organ failure * No enteral nutrition started Exclusion Criteria: * Pregnant women and prisoners * Hypotension is attributed to suspected or confirmed cardiogenic shock * Moribund patients (expected to pass within 72h) * Evidence of intestinal obstruction, ischemia, bleeding, perforation, fistulas or tract discontinuity * Sepsis suspected or confirmed due to an abdominal source * C. Difficile or other gastrointestinal infection that may manifest with diarrhea * Constipation as a pre-existing comorbidity * Use of pancreatic hormone stimulant or inhibitor during or immediately prior to hospital admission * Use of parenteral nutrition * Patients receiving cancer-related treatment in the last 6 months

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}}, 'enrollmentInfo': {'count': 0, 'type': 'ACTUAL'}}

2023-04-25