The 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

Status

Recruiting

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05112328

Acronym

PREZENT

Enrollment

170

Registered

2021-11-08

Start date

2021-07-07

Completion date

2026-07-31

Last updated

2021-11-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Critically Ill, Enteral Feeding, Exocrine Pancreatic Insufficiency

Brief summary

Determine the effect of high-dose pancreatic enzyme supplementation on nutritional indicators and clinical course in critically ill patients undergoing enteral nutrition.

Interventions

DRUGExocrine Pancreatic Enzyme

Pancreatic enzyme supplementation for critically ill patients on enteral nutrition

DRUGPlacebo

Placebo of Pancreatic enzyme for critically ill patients on enteral nutrition

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

SUPPORTIVE_CARE

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Change of Phase angle (°)	Baseline, 7 days after starting enteral nutrition, 14 days after starting enteral nutrition	Change from Baseline Phase angle (°) at 2 weeks or discharge

Secondary

Measure	Time frame	Description
Skeletal Muscle Mass (SMM) (kg)	Baseline, 7 days after starting enteral nutrition, 14 days after starting enteral nutrition	Skeletal Muscle Mass (SMM) (kg)

Countries

South Korea

Contacts

Primary ContactOh

faun1226@gmail.com+82-2-2072-3538

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026