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NCT Number: NCT05112328

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

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

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Key information

Conditions

Critically Ill Critical Illness Digestive System Diseases Disease Attributes Enteral Feeding Exocrine Pancreatic Insufficiency Pancreatic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seoul National University Hospital

Seoul, Jongno-gu, 03080, South Korea

Location status: Recruiting

Location contact

Seoul National University Hospital

CONTACT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Exocrine Pancreatic Enzyme

Drug

Pancreatic enzyme supplementation for critically ill patients on enteral nutrition

Other names: Norzyme

Placebo

Drug

Placebo of Pancreatic enzyme for critically ill patients on enteral nutrition

Primary outcomes

  1. Change of Phase angle (°)

    Time frame: Baseline, 7 days after starting enteral nutrition, 14 days after starting enteral nutrition

    Change from Baseline Phase angle (°) at 2 weeks or discharge

Secondary outcomes

  1. Skeletal Muscle Mass (SMM) (kg)

    Time frame: Baseline, 7 days after starting enteral nutrition, 14 days after starting enteral nutrition

    Skeletal Muscle Mass (SMM) (kg)

Study contacts

Contact information is provided by the study sponsor or research team.

Oh

CONTACT

[email protected]

+82-2-2072-3538

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

The Effects of Pancreatic Enzyme Supplementation in Critically Ill Patients on Enteral Feeding: Prospective Randomized Controlled Trial

Acronym: PREZENT

Important dates

Study start
2021
Primary completion
2026
Study completion
2026
First posted
Nov 8, 2021
Registry last updated
Nov 8, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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