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

Seoul National University

Status: Enrolling

Conditions: Enteral Feeding; Critically Ill; Exocrine Pancreatic Insufficiency

Treatments: Drug: Placebo; Drug: Exocrine Pancreatic Enzyme

Study type: Interventional

Funder types: Other

Identifiers

NCT05112328

2008-185-1153

Details and patient eligibility

About

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

Enrollment: 170 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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170 participants in 2 patient groups, including a placebo group

Intervention

Experimental group

Description:

Exocrine Pacancreatic enzyme(Norzyme Capsule 40000 capsules) after meals 3 times a day

Treatment:

Drug: Exocrine Pancreatic Enzyme

Control

Placebo Comparator group

Description:

Placebo after meals 3 times a day

Treatment:

Drug: Placebo