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

NCT05112328 | Recruiting

• 1 other identifier: 2008-185-1153
• Study Type: interventional
• Target: 170
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Critically Ill; Enteral Feeding; Exocrine Pancreatic Insufficiency

Outcome Measures

Primary Outcomes (1)

• 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 (1)

• Skeletal Muscle Mass (SMM) (kg)

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

Study Arms (2)

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

Exocrine Pancreatic Enzyme DRUG

Pancreatic enzyme supplementation for critically ill patients on enteral nutrition

Also known as: Norzyme

Intervention

Placebo DRUG

Placebo of Pancreatic enzyme for critically ill patients on enteral nutrition

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Hospital

Seoul, Jongno-gu, 03080, South Korea

RECRUITING

MeSH Terms

Conditions

Critical Illness; Exocrine Pancreatic Insufficiency

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pancreatic Diseases; Digestive System Diseases

Central Study Contacts

Oh

CONTACT

+82-2-2072-3538; faun1226@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor

Study Record Dates

• First Submitted: October 7, 2021
• First Posted: November 8, 2021
• Study Start: July 7, 2021
• Primary Completion (Estimated): July 31, 2026
• Study Completion (Estimated): July 31, 2026
• Last Updated: November 8, 2021

Record last verified: 2021-11

Locations

KR (1)