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NCT05112328 Clinical Trial

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

Critically Ill Clinical Trial

— PREZENT  

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

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05112328
Other study ID # 2008-185-1153
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date July 7, 2021
Est. completion date July 31, 2026

Study information
Verified date November 2021
Source Seoul National University Hospital
Contact Oh
Phone +82-2-2072-3538
Email faun1226@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

Recruitment information / eligibility
Status Recruiting
Enrollment 170
Est. completion date July 31, 2026
Est. primary completion date July 31, 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design

Related Conditions & MeSH terms

Intervention

Drug:
• Exocrine Pancreatic Enzyme
Pancreatic enzyme supplementation for critically ill patients on enteral nutrition
• Placebo
Placebo of Pancreatic enzyme for critically ill patients on enteral nutrition

Locations
Country Name City State
Korea, Republic of Seoul National University Hospital Seoul Jongno-gu

Sponsors (1)
Lead Sponsor Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 Skeletal Muscle Mass (SMM) (kg) Skeletal Muscle Mass (SMM) (kg) Baseline, 7 days after starting enteral nutrition, 14 days after starting enteral nutrition
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