ReliZORB for Multiple Organ Failure
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores whether RELiZORB™, a cartridge containing digestive enzymes, can help individuals with multiple organ failure absorb nutrients more effectively from tube feedings. RELiZORB™ has already received approval for some patients with tube feedings, but this trial specifically tests its use for those with multiple organ failure. Participants will receive either the RELiZORB™ cartridge or a placebo (an inactive, harmless cartridge) to compare outcomes. Suitable candidates for this trial include those experiencing multiple organ failure who are starting or have recently started tube feeding. As an unphased trial, this study provides a unique opportunity to enhance understanding of how RELiZORB™ may benefit patients with multiple organ failure.
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.
What prior data suggests that this device is safe for use in patients with multiple organ failure?
Research has shown that RELiZORB™ is safe and well-tolerated. Studies have found that using RELiZORB™ increases fatty acids in the blood, indicating improved fat absorption. Importantly, these studies reported no major safety issues. The FDA has approved RELiZORB™ for patients aged 5 and older who need help digesting tube feedings, which adds confidence in its safety for humans. While this study focuses on patients with multiple organ failure, RELiZORB™ has demonstrated safety in other situations.12345
Why are researchers excited about this trial?
ReliZORB is unique because it offers a novel way to deliver essential nutrients to patients with multiple organ failure. Unlike traditional treatments that rely on standard enteral feeding, ReliZORB uses a specialized cartridge that connects directly to feeding tubes. This allows for more efficient digestion and absorption of fats, which can be crucial for patients who are struggling with nutrient absorption due to organ failure. Researchers are excited about ReliZORB's potential to improve nutrient delivery and overall patient outcomes in a way that standard feeding methods can't match.
What evidence suggests that RELiZORB™ is effective for improving nutrition tolerance in patients with multiple organ failure?
Studies have shown that RELiZORB improves fat absorption in people with digestion issues due to pancreatic problems. This device uses a special enzyme called lipase to break down fats, making them easier for the body to use. Research indicates that many patients who used RELiZORB had better body mass index (BMI) scores after 12 months. It is safe and well tolerated, causing few side effects. In this trial, some participants will receive RELiZORB to explore its potential in helping people with multiple organ failure meet their nutritional needs, while others will receive a placebo for comparison.16789
Who Is on the Research Team?
George Kasotakis, MD MPH
Principal Investigator
Inova Fairfax Medical Campus
Are You a Good Fit for This Trial?
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive enteral nutrition through ReliZORB™ or placebo cartridges for 5 days
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
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.
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Placebo Group
RELiZORB™ cartridges connect in-line with existing enteral feeding pump tubing sets and patient extension sets or enteral feeding tubes.
Placebo cartridges connect in-line with existing enteral feeding pump tubing sets and patient extension sets or enteral feeding tubes
Find a Clinic Near You
Who Is Running the Clinical Trial?
Inova Health Care Services
Lead Sponsor
Duke University
Lead Sponsor
Alcresta Therapeutics, Inc.
Industry Sponsor
Citations
Evaluating the Utility of RELiZORB™ for Treating Feeding ...
The purpose of this research is to determine if the use of RELiZORB™ improves nutrition tolerance and helps critically ill patients meet their nutrition ...
Alcresta Therapeutics Announces Enrollment of First ...
Studies have demonstrated that RELiZORB is safe, well tolerated, and effective in improving fat absorption for patients with pancreatic ...
Alcresta Therapeutics Announces Enrollment of First ...
Studies have demonstrated that RELiZORB is safe, well tolerated, and effective in improving fat absorption for patients with pancreatic ...
Evaluating the Utility of RELiZORB™ for Treating Feeding ...
Overview. The purpose of this research is to determine if the use of RELiZORB™ improves nutrition tolerance and helps critically ill ...
Evaluation of the Effectiveness of In‐line Immobilized ...
Fifty percentage of patients achieved ≥50th percentile for body mass index at 12 months, compared with 37.1% at baseline. Immobilized lipase ...
Absorption and Safety With Sustained Use of RELiZORB ...
Conclusions: RELiZORB use was found to be safe, well tolerated, and resulted in increased levels of FAs in RBCs and plasma. This is the first prospective study ...
ReliZORB for Multiple Organ Failure
The purpose of this research is to determine if the use of RELiZORB™ improves nutrition tolerance and helps critically ill patients meet their nutrition ...
Clinical Studies
Results from this study demonstrated that RELiZORB, when used per the intended use, was safe and well-tolerated and reduced signs of gastrointestinal ...
Absorption and Safety With Sustained Use of RELiZORB ...
Protocol 0000498: Multicenter, open label study to evaluate the effect of sustained RELiZORB (immobilized lipase) cartridge use during enteral feeding on fat ...
Unbiased Results
We believe in providing patients with all the options.
Your Data Stays Your Data
We only share your information with the clinical trials you're trying to access.
Verified Trials Only
All of our trials are run by licensed doctors, researchers, and healthcare companies.