Acute Pancreatitis (AP), Enhancing Enteral Nutrition Tolerance
Conditions
Keywords
RELiZORB, Acute Pancreatitis, AP, EN support, Enteral nutrition (EN), Immobilized lipase cartridge, Digestive enzyme cartridge, Feeding intolerance, Enteral nutrition intolerance, Fat malabsorption
Brief summary
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.
Interventions
DEVICERELiZORB digestive enzyme (immobilized lipase) cartridge
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.
Sponsors
Northwell Health
Alcresta Therapeutics, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percent of goal nutrition delivered at 72 hours | From enrollment to the end of treatment 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent of goal nutrition delivered at 24 hours | From enrollment to 24 hours after starting RELiZORB | Change from baseline in goal percentage of enteral nutrition (kcal/kg/day) received 1 day (24 hours) following initiation of RELiZORB. |
| Responders at 72 hours | From enrollment to end of treatment 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. |
| Responders at 24 hours | From enrollment to 24 hours after starting treatment | Percent of patients considered responders defined as receiving ≥80% of their daily enteral nutritional goal 1 day (24 hours) following initiation of RELiZORB use. |
| Vomiting | From enrollment to completion of treatment at 72 hours | Change in the number of vomiting episodes per 24 hour period from baseline to 24 and 72 hours following initiation of RELiZORB use |
| Stool volume | From enrollment to completion of treatment at 72 hours | 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) |
| Bowel movements | From enrollment to completion of treatment at 72 hours | Change in number of bowel movement episodes in 24 hours from baseline to 24 hours and 72 hours after RELiZORB (if no rectal tube) |
| Feeding Interruptions | From enrollment to completion of treatment at 72 hours | Number of unplanned interruptions in tube feeding from baseline to 24 hours and 72 hours following initiation of RELiZORB use |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORLaura Hansen, MD
Northwell Health
PRINCIPAL_INVESTIGATORRafael Barrera, MD
Northwell Health
Outcome results
None listed