Effects of pancreatic enzyme supplementation in critically ill patients on enteral feeding
The Effects of Pancreatic Enzyme Supplementation in Critically Ill Patients on Enteral Feeding: Prospective Randomized Controlled Trial
This study is testing if giving extra pancreatic enzymes to critically ill patients on feeding tubes can help them get better faster compared to a placebo.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 170 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Seoul National University Hospital Academic / other |
| Locations | 1 site (Seoul, Jongno-gu) |
| Trial ID | NCT05112328 on ClinicalTrials.gov |
What this trial studies
This study investigates the impact of high-dose pancreatic enzyme supplementation on nutritional indicators and the clinical course of critically ill patients receiving enteral nutrition. It aims to determine whether these supplements can improve outcomes in patients with exocrine pancreatic insufficiency. The trial will involve a comparison between the enzyme supplementation and a placebo in a controlled setting. Participants will be adults hospitalized in the intensive care unit who meet specific criteria related to their health status.
Who should consider this trial
Good fit: Ideal candidates are adults aged 19 and older who are hospitalized in the intensive care unit and receiving enteral nutrition with risk factors for pancreatic exocrine dysfunction.
Not a fit: Patients with chronic pancreatitis, unresectable pancreatic cancer, or other underlying diseases that complicate the effects of enzyme supplementation may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance nutritional outcomes and overall recovery for critically ill patients on enteral feeding.
How similar studies have performed: While there is limited information on similar studies, the approach of using pancreatic enzyme supplementation in critically ill patients is relatively novel and may provide new insights into treatment options.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adults 19 years and older * Hospitalized in the surgical/medical intensive care unit of the Seoul National University Hospital * Enteral nutrition * Patients who consented to this study * Patients with risk factors for pancreatic exocrine dysfunction * Shock (Norepinephrine) * Sepsis (3 rd definition of sepsis) * Diabetes * Cardiac arrest * hyperlactatemia serum lactate \> 2 mmol/L) * Mechanical ventilation * Continuous renal replacement therapy Exclusion Criteria: * chronic pancreatitis * unresectable pancreatic cancer * History of pancreatectomy * Underlying diseases in which the effect of Exocrine pancreatic enzyme administration is difficult to show * Inflammatory bowel disease * Short bowel syndrome
Where this trial is running
Seoul, Jongno-gu
- Seoul National University Hospital — Seoul, Jongno-gu, South Korea (Recruiting)
Study contacts
- Study coordinator: Oh
- Email: faun1226@gmail.com
- Phone: +82-2-2072-3538
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.