The Effects of Pancreatic Enzyme Supplementation in Criti... | NCT05112328

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

NCT05112328

Sponsor

Seoul National University Hospital

Status

Recruiting

Last Update Posted

Nov 8, 2021Actual

Enrollment

170Estimated

Phase

Not Applicable

Conditions

Critically Ill
Enteral Feeding
Exocrine Pancreatic Insufficiency

Interventions

Exocrine Pancreatic Enzyme
Placebo

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2021

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 7, 2021Actual

Primary Completion Date

Jul 31, 2026Estimated

Completion Date

Jul 31, 2026Estimated

First Submitted Date

Oct 7, 2021

First Submission Date that Met QC Criteria

Nov 4, 2021

First Posted Date

Nov 8, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 4, 2021

Last Update Posted Date

Nov 8, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

170Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Intervention	Experimental	Exocrine Pacancreatic enzyme(Norzyme Capsule 40000 capsules) after meals 3 times a day	Drug: Exocrine Pancreatic Enzyme
Control	Placebo Comparator	Placebo after meals 3 times a day	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Exocrine Pancreatic Enzyme	Drug	Pancreatic enzyme supplementation for critically ill patients on enteral nutrition	Intervention

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change of Phase angle (°)	Change from Baseline Phase angle (°) at 2 weeks or discharge	Baseline, 7 days after starting enteral nutrition, 14 days after starting enteral nutrition

Secondary Outcomes

Measure	Description	Time Frame
Skeletal Muscle Mass (SMM) (kg)	Skeletal Muscle Mass (SMM) (kg)	Baseline, 7 days after starting enteral nutrition, 14 days after starting enteral nutrition

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Name	Role	Phone	Extension	Email
Oh	Contact	+82-2-2072-3538		faun1226@gmail.com

Facility	Status	City	State	ZIP	Country	Contacts
Seoul National University Hospital	Recruiting	Seoul	Jongno-gu	03080	South Korea

Condition Browse Module

MeSH Terms

ID	Term
D016638	Critical Illness
D010188	Exocrine Pancreatic Insufficiency

Ancestor Terms

ID	Term
D020969	Disease Attributes
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D010182	Pancreatic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided