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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorSeoul National University Hospital

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

chronic pancreatitis

unresectable pancreatic cancer

History of pancreatectomy

Underlying diseases in which the effect of Exocrine pancreatic enzyme administration is difficult to show

Trial design

Design model

Parallel

Treatments tested in this trial

  • Exocrine Pancreatic Enzyme

    Drug

    Pancreatic enzyme supplementation for critically ill patients on enteral nutrition

  • Placebo

    Drug

    Placebo of Pancreatic enzyme for critically ill patients on enteral nutrition

Treatment groups

170 Participants
are divided into 2 treatment groups
Group A: InterventionExperimental treatment 1 intervention
Group B: ControlPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change of Phase angle (°)

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 outcomes

1

Skeletal Muscle Mass (SMM) (kg)

Skeletal Muscle Mass (SMM) (kg)

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

Other outcomes

Sponsors and contacts

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