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

Primary Purpose

Critically Ill, Enteral Feeding, Exocrine Pancreatic Insufficiency

Status

Recruiting

Phase

Not Applicable

Locations

Korea, Republic of

Study Type

Interventional

Intervention

Exocrine Pancreatic Enzyme

Placebo

About this trial

This is an interventional supportive care trial for Critically Ill

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Seoul National University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Intervention

Control

Arm Description

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

Placebo after meals 3 times a day

Outcomes

Primary Outcome Measures

Change of Phase angle (°)

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

Secondary Outcome Measures

Skeletal Muscle Mass (SMM) (kg)

Full Information

NCT ID

NCT05112328

First Posted

October 7, 2021

Last Updated

November 4, 2021

Sponsor

Seoul National University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT05112328

Brief Title

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

Acronym

PREZENT

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2021

Overall Recruitment Status

Recruiting

Study Start Date

July 7, 2021 (Actual)

Primary Completion Date

July 31, 2026 (Anticipated)

Study Completion Date

July 31, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Seoul National University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Critically Ill, Enteral Feeding, Exocrine Pancreatic Insufficiency

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

170 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Intervention

Arm Type

Experimental

Arm Description

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

Arm Title

Control

Arm Type

Placebo Comparator

Arm Description

Placebo after meals 3 times a day

Intervention Type

Drug

Intervention Name(s)

Exocrine Pancreatic Enzyme

Other Intervention Name(s)

Norzyme

Intervention Description

Pancreatic enzyme supplementation for critically ill patients on enteral nutrition

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Placebo of Pancreatic enzyme for critically ill patients on enteral nutrition

Primary Outcome Measure Information:

Title

Change of Phase angle (°)

Description

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

Time Frame

Baseline, 7 days after starting enteral nutrition, 14 days after starting enteral nutrition

Secondary Outcome Measure Information:

Title

Skeletal Muscle Mass (SMM) (kg)

Description

Skeletal Muscle Mass (SMM) (kg)

Time Frame

Baseline, 7 days after starting enteral nutrition, 14 days after starting enteral nutrition

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Phone

+82-2-2072-3538

faun1226@gmail.com

Facility Information:

Facility Name

Seoul National University Hospital

City

Seoul

State/Province

Jongno-gu

ZIP/Postal Code

03080

Country

Korea, Republic of

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Seoul National University Hospital

12. IPD Sharing Statement

Learn more about this trial

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

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