The Effects of Pancreatic Enzyme Supplementation in Critically Ill Patients on Enteral Feeding

Not Applicable

Recruiting

• Conditions: Critically Ill; Enteral Feeding; Exocrine Pancreatic Insufficiency
• Interventions: Drug: Exocrine Pancreatic Enzyme; Drug: Placebo

• Registration Number: NCT05112328
• Lead Sponsor: Seoul National University Hospital

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2021-07-07
• Study First Submitted: 2021-10-07
• Status Verified: 2021-11
• Study First Submitted QC: 2021-11-04
• Last Update Submitted: 2021-11-04
• Study First Posted: 2021-11-08
• Last Update Posted: 2021-11-08
• Primary Completion: 2026-07-31
• Study Completion: 2026-07-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 170

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention	Exocrine Pancreatic Enzyme	Exocrine Pacancreatic enzyme(Norzyme Capsule 40000 capsules) after meals 3 times a day
Control	Placebo	Placebo after meals 3 times a day

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Skeletal Muscle Mass (SMM) (kg)	Baseline, 7 days after starting enteral nutrition, 14 days after starting enteral nutrition	Skeletal Muscle Mass (SMM) (kg)

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Jongno-gu, Korea, Republic of