Evaluating RELiZORB Use for the Treatment of Feeding Intolerance in Adults With Moderate to Severe Acute Pancreatitis

Northwell Health

Status and phase: Invitation-only; Phase 4

Conditions: Enhancing Enteral Nutrition Tolerance; Acute Pancreatitis (AP)

Treatments: Device: RELiZORB digestive enzyme (immobilized lipase) cartridge

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT07583342

25-0106-LIJ

Details and patient eligibility

About

The goal of this study is to learn if Relizorb, a fat-digesting enzyme, can improve tolerance of tube feeds in adult patients with moderate to severe pancreatitis. The main question it aims to answer is:

Does Relizorb allow more nutrition to be delivered to participants than they received without it?

Participants will be observed with standard, universal monitoring after adding Relizorb to their nutrition regimen.

Enrollment: 15 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or female aged 18 + years of age
• Admission to the Surgical Intensive Care Unit in the Northwell Health hospital system
• Moderate to severe acute pancreatitis based on Atlanta criteria
• Inability to tolerate ≥75% of goal EN (25 kcal/kg/d)

Exclusion criteria

• Moribund patients expected to expire within 120 hours
• Evidence of unresolved intestinal obstruction, ischemia, bleeding, perforation, fistulas or tract discontinuity, or other contraindication for enteral nutrition
• Diagnosis or evidence of C. Difficile or other gastrointestinal infection that may manifest with diarrhea
• Pre-existing constipation defined as laxative or stool softener use prior to admission to the hospital
• Patients receiving cancer-related treatment in the last 3 months
• History of cystic fibrosis
• Any other reason that the treating or investigator team considers to be a contraindication to enteral nutrition

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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15 participants in 1 patient group

Relizorb treatment

Experimental group

Description:

Patients with moderate to severe pancreatitis who are not tolerating sufficient enteral nutrition will have a lipase-containing cartridge (Relizorb) placed in-line with their enteral nutrition tubing, to digest the fat in the formula prior to entering the patient's intestine.

Treatment:

Device: RELiZORB digestive enzyme (immobilized lipase) cartridge