Use of ReliZORB for Feeding Intolerance in Critically Ill Patients

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Multi Organ Failure, Critical Illness

Intervention / Treatment
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* Drug: Relizorb
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 89 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ReliZORB<br>ReliZORB enzyme cartridges will be used with enteral feedings for 5 days | Drug: Relizorb<br>* Relizorb cartridges will be used with routine enteral feedings for 5 days<br>|
| Placebo Comparator: Placebo<br>Placebo enzyme cartridges will be used with enteral feedings for 5 days | Other: Placebo<br>* Placebo cartridges will be used with routine enteral feedings for 5 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of episodes of feeding intolerance | To assess the efficacy of ReliZORB™ in enhancing enteral nutrition tolerance in critically ill adults with multi-organ failure. | 5 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Daily maximum rate of enteral nutrition |  | 5 days | 
| Percent of goal nutrition calories achieved daily |  | 5 days | 
| Enteral nutrition formula when goal rate is achieved |  | 5 days | 
| Days from initiation of enteral feedings to achieved goal rate |  | 5 days | 
| Days on achieved goal rate |  | 5 days | 
| Enteral nutrition formula at end of study |  | 5 days | 
| Daily volume of enteral nutrition (in cc) |  | 5 days | 
| Total volume of enteral nutrition administered |  | 5 days | 
| Total calories administered |  | 5 days | 
| Total protein (grams) administered |  | 5 days |