Use of ReliZORB for Feeding Intolerance in Critically Ill Patients

Critical Illness Clinical Trial

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05710315
• Other study ID #: Pro00110857
• Status: Withdrawn
• Phase: Phase 4
• Start date: May 1, 2023
• Est. completion date: January 30, 2024

Study information

• Verified date: April 2023
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: January 30, 2024
• Est. primary completion date: July 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 89 Years

Eligibility

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

Related Conditions & MeSH terms

• Critical Illness
• Multi Organ Failure
• Multiple Organ Failure

Intervention

Drug:
• Relizorb
Relizorb cartridges will be used with routine enteral feedings for 5 days

Other:
• Placebo
Placebo cartridges will be used with routine enteral feedings for 5 days

Locations

Country	Name	City	State
United States	Duke University Hospital	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Daily maximum rate of enteral nutrition		5 days
Secondary	Percent of goal nutrition calories achieved daily		5 days
Secondary	Enteral nutrition formula when goal rate is achieved		5 days
Secondary	Days from initiation of enteral feedings to achieved goal rate		5 days
Secondary	Days on achieved goal rate		5 days
Secondary	Enteral nutrition formula at end of study		5 days
Secondary	Daily volume of enteral nutrition (in cc)		5 days
Secondary	Total volume of enteral nutrition administered		5 days
Secondary	Total calories administered		5 days
Secondary	Total protein (grams) administered		5 days