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

Phase 4Enrolling By InvitationNCT07583342

Northwell Health15 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Acute Pancreatitis (AP)Enhancing Enteral Nutrition Tolerance

Interventions

RELiZORB digestive enzyme (immobilized lipase) cartridgeDEVICE

An in-line digestive enzyme cartridge designed for hydrolyzing lipids within enteral nutrition will be used to improve tube feed tolerance in patients with moderate to severe pancreatitis.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (5)

South Shore University Hospital

Bay Shore, New York, United States

North Shore University Hospital

Manhasset, New York, United States

Lenox Hill Hospital

Manhattan, New York, United States

Long Island Jewish Medical Center

New Hyde Park, New York, United States

Outcomes

Primary Outcomes

Percent of goal nutrition delivered at 72 hours

Change from baseline in percentage of goal enteral nutrition (kcal/kg/day) received 3 days (72 hours) following initiation of RELiZORB. Baseline is considered the 24 hours prior to RELiZORB start.

Time frame: From enrollment to the end of treatment at 72 hours

Secondary Outcomes

Percent of goal nutrition delivered at 24 hours

Change from baseline in goal percentage of enteral nutrition (kcal/kg/day) received 1 day (24 hours) following initiation of RELiZORB.

Time frame: From enrollment to 24 hours after starting RELiZORB

Responders at 72 hours

Percent of patients considered responders defined as receiving ≥80% of their daily enteral nutritional goal 3 days (72 hours) following initiation of RELiZORB use.

Time frame: From enrollment to end of treatment at 72 hours

Responders at 24 hours

Percent of patients considered responders defined as receiving ≥80% of their daily enteral nutritional goal 1 day (24 hours) following initiation of RELiZORB use.

Time frame: From enrollment to 24 hours after starting treatment

Vomiting

Change in the number of vomiting episodes per 24 hour period from baseline to 24 and 72 hours following initiation of RELiZORB use

Time frame: From enrollment to completion of treatment at 72 hours

Stool volume

Change in stool volume per 24 hour period from baseline to 24 and 72 hours following initiation of RELiZORB use (if rectal tube is in place)

Time frame: From enrollment to completion of treatment at 72 hours

Data from ClinicalTrials.gov

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