Back to resultsUse of ReliZORB for Feeding Intolerance in Critically Ill Patients
Primary Purpose
Multi Organ Failure, Critical Illness
Status
Withdrawn
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Relizorb
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Multi Organ Failure
Eligibility Criteria
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
Sites / Locations
- Duke University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
ReliZORB
Placebo
Arm Description
ReliZORB enzyme cartridges will be used with enteral feedings for 5 days
Placebo enzyme cartridges will be used with enteral feedings for 5 days
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Daily maximum rate of enteral nutrition
Percent of goal nutrition calories achieved daily
Enteral nutrition formula when goal rate is achieved
Days from initiation of enteral feedings to achieved goal rate
Days on achieved goal rate
Enteral nutrition formula at end of study
Daily volume of enteral nutrition (in cc)
Total volume of enteral nutrition administered
Total calories administered
Total protein (grams) administered
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05710315
Brief Title
Use of ReliZORB for Feeding Intolerance in Critically Ill Patients
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Withdrawn
Why Stopped
PI initiated study closure. He will be leaving the study site for a new position in the coming months.
Study Start Date
May 1, 2023 (Anticipated)
Primary Completion Date
July 30, 2023 (Anticipated)
Study Completion Date
January 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multi Organ Failure, Critical Illness
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ReliZORB
Arm Type
Experimental
Arm Description
ReliZORB enzyme cartridges will be used with enteral feedings for 5 days
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo enzyme cartridges will be used with enteral feedings for 5 days
Intervention Type
Drug
Intervention Name(s)
Relizorb
Intervention Description
Relizorb cartridges will be used with routine enteral feedings for 5 days
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
Placebo cartridges will be used with routine enteral feedings for 5 days
Primary Outcome Measure Information:
Title
Number of episodes of feeding intolerance
Description
To assess the efficacy of ReliZORB™ in enhancing enteral nutrition tolerance in critically ill adults with multi-organ failure.
Time Frame
5 days
Secondary Outcome Measure Information:
Title
Daily maximum rate of enteral nutrition
Time Frame
5 days
Title
Percent of goal nutrition calories achieved daily
Time Frame
5 days
Title
Enteral nutrition formula when goal rate is achieved
Time Frame
5 days
Title
Days from initiation of enteral feedings to achieved goal rate
Time Frame
5 days
Title
Days on achieved goal rate
Time Frame
5 days
Title
Enteral nutrition formula at end of study
Time Frame
5 days
Title
Daily volume of enteral nutrition (in cc)
Time Frame
5 days
Title
Total volume of enteral nutrition administered
Time Frame
5 days
Title
Total calories administered
Time Frame
5 days
Title
Total protein (grams) administered
Time Frame
5 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
89 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
George Kasotakis, MD
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Duke University Hospital
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Use of ReliZORB for Feeding Intolerance in Critically Ill Patients
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