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

NCT ID: NCT05112328

Last Updated: 2021-11-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

170 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-07-07

Study Completion Date

2026-07-31

Brief Summary

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

Detailed Description

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Conditions

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Critically Ill Enteral Feeding Exocrine Pancreatic Insufficiency

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Intervention

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

Group Type EXPERIMENTAL

Exocrine Pancreatic Enzyme

Intervention Type DRUG

Pancreatic enzyme supplementation for critically ill patients on enteral nutrition

Control

Placebo after meals 3 times a day

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo of Pancreatic enzyme for critically ill patients on enteral nutrition

Interventions

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Exocrine Pancreatic Enzyme

Pancreatic enzyme supplementation for critically ill patients on enteral nutrition

Intervention Type DRUG

Placebo

Placebo of Pancreatic enzyme for critically ill patients on enteral nutrition

Intervention Type DRUG

Other Intervention Names

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Norzyme

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Seung-Young Oh

Clinical Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Seoul National University Hospital

Seoul, Jongno-gu, South Korea

Site Status RECRUITING

Countries

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South Korea

Central Contacts

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Oh

Role: CONTACT

Phone: +82-2-2072-3538

Email: [email protected]

Facility Contacts

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Seoul National University Hospital

Role: primary

Other Identifiers

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2008-185-1153

Identifier Type: -

Identifier Source: org_study_id