ReliZORB for Multiple Organ Failure

Recruiting at 1 trial location

Overseen By Laura E Madarasz, MS, BA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Inova Health Care Services

Must not be taking: Pancreatic hormones, Parenteral nutrition

Disqualifiers: Pregnancy, Prisoners, Cancer treatment, others

Compensation: Varies

Number of Visits: 2

Duration: 5 days

32 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this research is to determine if the use of RELiZORB™ improves nutrition tolerance and helps critically ill patients meet their nutrition goals. RELiZORB™ is a digestive enzyme cartridge that contains lipase and works as a pancreatic enzyme replacement. It promotes breaking down fat and helps the body absorb it. The device connects with tube feedings to help the body with digestion. RELiZORB™ is approved by the U.S. Food and Drug Administration (FDA) for use with tube feedings in patients 5 years of age or older. While the use of RELiZORB™ in this study is consistent with the FDA approval, the use of RELiZORB™ in patients with multi organ failure is not in the current standard of care practice at Inova Health Care facilities.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you are using pancreatic hormone stimulants or inhibitors, you may not be eligible to participate.

Research Team

George Kasotakis, MD MPH

Principal Investigator

Inova Fairfax Medical Campus

Eligibility Criteria

This trial is for critically ill adults with multi-organ failure who have been admitted to the ICU within the last 72 hours and haven't started enteral nutrition. It excludes pregnant women, prisoners, those with certain infections or shock due to heart problems, recent cancer treatment recipients, and patients expected to pass away within 72 hours.

Inclusion Criteria

I need tube feeding but haven't started it yet.

I need medication to support my heart and a machine to help me breathe.

My legal representative has consented for me as I am unable to do so myself.

Exclusion Criteria

I have used medication that affects pancreatic hormone levels around the time I was admitted to the hospital.

I have a gastrointestinal infection causing diarrhea.

Pregnant women and prisoners

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1 week

1 visit (in-person)

Treatment

Participants receive enteral nutrition through ReliZORB™ or placebo cartridges for 5 days

5 days

Daily monitoring (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 week

1 visit (in-person)

Treatment Details

Interventions

• Placebo
• ReliZORB

Trial Overview The study tests if ReliZORB™ improves feeding tolerance in critically ill patients. ReliZORB™ is a digestive enzyme cartridge that helps break down fats during tube feedings. Participants will either receive ReliZORB™ or a placebo alongside their standard care.

Participant Groups

Group I: RELiZORB Experimental Treatment 1 Intervention

RELiZORB™ cartridges connect in-line with existing enteral feeding pump tubing sets and patient extension sets or enteral feeding tubes.

Group II: Placebo Placebo Group 1 Intervention

Placebo cartridges connect in-line with existing enteral feeding pump tubing sets and patient extension sets or enteral feeding tubes

Who Is Running the Clinical Trial?

Inova Health Care Services

Lead Sponsor

Trials

80

Recruited

22,700+

Duke University

Lead Sponsor

Trials

2,495

Recruited

5,912,000+

Alcresta Therapeutics, Inc.

Industry Sponsor

Trials

6

Recruited

240+