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

November 4, 2021 updated by: Seung-Young Oh, Seoul National University Hospital

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

170

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Korea, Republic of
    • Jongno-gu
      • Seoul, Jongno-gu, Korea, Republic of, 03080
        • Recruiting
        • Seoul National University Hospital
        • Contact:
          • Seoul National University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Intervention
Exocrine Pacancreatic enzyme(Norzyme Capsule 40000 capsules) after meals 3 times a day
Drug: Exocrine Pancreatic Enzyme
Pancreatic enzyme supplementation for critically ill patients on enteral nutrition
Other Names:
  • Norzyme
Placebo Comparator: Control
Placebo after meals 3 times a day
Drug: Placebo
Placebo of Pancreatic enzyme for critically ill patients on enteral nutrition

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Baseline, 7 days after starting enteral nutrition, 14 days after starting enteral nutrition

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Baseline, 7 days after starting enteral nutrition, 14 days after starting enteral nutrition

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 7, 2021

Primary Completion (Anticipated)

July 31, 2026

Study Completion (Anticipated)

July 31, 2026

Study Registration Dates

First Submitted

October 7, 2021

First Submitted That Met QC Criteria

November 4, 2021

First Posted (Actual)

November 8, 2021

Study Record Updates

Last Update Posted (Actual)

November 8, 2021

Last Update Submitted That Met QC Criteria

November 4, 2021

Last Verified

November 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2008-185-1153

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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