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NCT05710315 | Withdrawn | Multi Organ Failure


Use of ReliZORB for Feeding Intolerance in Critically Ill Patients
Sponsor:

Duke University

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.

Condition or disease

Multi Organ Failure

Critical Illness

Intervention/treatment

Relizorb

Placebo

Phase

Phase 4

Study Type : Interventional
Estimated Enrollment : 0 participants
Masking: Single
Primary Purpose: Treatment
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
Actual Study Start Date : May 1, 2023
Estimated Primary Completion Date : July 30, 2023
Estimated Study Completion Date : January 30, 2024
Arm Intervention/treatment

Experimental: ReliZORB

ReliZORB enzyme cartridges will be used with enteral feedings for 5 days

Drug: Relizorb

Placebo Comparator: Placebo

Placebo enzyme cartridges will be used with enteral feedings for 5 days

Other: Placebo

Ages Eligible for Study: 18 Years to 89 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
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

Use of ReliZORB for Feeding Intolerance in Critically Ill Patients

Location Details


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Use of ReliZORB for Feeding Intolerance in Critically Ill Patients

How to Participate

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Locations


Not yet recruiting

United States, North Carolina

Duke University Hospital

Durham, North Carolina, United States, 27710

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