Critically IllPREZENTNCT05112328
The Effects of Pancreatic Enzyme Supplementation in Critically Ill Patients on Enteral Feeding
A study testing Exocrine Pancreatic Enzyme in people with Critically Ill and Enteral Feeding, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
Determine the effect of high-dose pancreatic enzyme supplementation on nutritional indicators and clinical course in critically ill patients undergoing enteral nutrition. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Critically Ill, Enteral Feeding, Exocrine Pancreatic Insufficiency
- What is being tested?
- Exocrine Pancreatic Enzyme
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 170 participants
- Where
- 1 siteSouth Korea
- Study dates
- 7 Jul 2021to 31 Jul 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Show all 12Show fewer
- Sepsis (3 rd definition of sepsis)
- Diabetes
- Cardiac arrest
- hyperlactatemia serum lactate > 2 mmol/L)
- Mechanical ventilation
- Continuous renal replacement therapy
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University Hospital
Seoul, Jongno-gu, 03080
Seoul National University Hospital
About this study
Official title: The Effects of Pancreatic Enzyme Supplementation in Critically Ill Patients on Enteral Feeding: Prospective Randomized Controlled Trial
Determine the effect of high-dose pancreatic enzyme supplementation on nutritional indicators and clinical course in critically ill patients undergoing enteral nutrition.
- Being tested
- Exocrine Pancreatic Enzyme, Placebo
- Medical subject headings
- Critical Illness, Exocrine Pancreatic Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exocrine Pancreatic EnzymeDrug
Also called Norzyme
Pancreatic enzyme supplementation for critically ill patients on enteral nutrition
PlaceboDrug
Placebo of Pancreatic enzyme for critically ill patients on enteral nutrition
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Exocrine Pacancreatic enzyme(Norzyme Capsule 40000 capsules) after meals 3 times a day Receives: Drug: Exocrine Pancreatic Enzyme |
| Control | Placebo comparator | Placebo after meals 3 times a day Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of Phase angle (°)
Change from Baseline Phase angle (°) at 2 weeks or discharge
Measured: 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)
Measured: Baseline, 7 days after starting enteral nutrition, 14 days after starting enteral nutrition
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2021
- Study start7 Jul 2021
- Primary completion31 Jul 2026 (estimated)
- Study completion31 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Critically IllStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 170 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Seung-Young Oh, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05112328
- Sponsor's protocol ID
- 2008-185-1153
- Acronym
- PREZENT
- Status last verified
- Nov 2021
- First submitted
- 7 Oct 2021
- Last updated
- 8 Nov 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Pancreatic Enzyme Supplementation in Critically Ill Patients on Enteral Feeding: Prospective Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05112328
- Acronym / sponsor ID
- PREZENT / 2008-185-1153
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 170 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 7 Jul 2021 (actual)
- Primary completion
- 31 Jul 2026 (estimated)
- Study completion
- 31 Jul 2026 (estimated)
- First posted
- 8 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Determine the effect of high-dose pancreatic enzyme supplementation on nutritional indicators and clinical course in critically ill patients undergoing enteral nutrition.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Drug: Exocrine Pancreatic EnzymeExocrine Pacancreatic enzyme(Norzyme Capsule 40000 capsules) after meals 3 times a day |
| Control | Placebo comparator | Drug: PlaceboPlacebo after meals 3 times a day |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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
Key exclusion criteria (6 listed)
- chronic pancreatitis
- unresectable pancreatic cancer
- History of pancreatectomy
- Underlying diseases in which the effect of Exocrine pancreatic enzyme administration is difficult to show
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exocrine Pancreatic EnzymeAlso: NorzymePancreatic enzyme supplementation for critically ill patients on enteral nutrition | Drug | Intervention |
| PlaceboPlacebo of Pancreatic enzyme for critically ill patients on enteral nutrition | Drug | Control |
Primary outcome
Change of Phase angle (°)
Time frame: Baseline, 7 days after starting enteral nutrition, 14 days after starting enteral nutrition
Change from Baseline Phase angle (°) at 2 weeks or discharge
1 secondary outcome
Skeletal Muscle Mass (SMM) (kg)
Time frame: Baseline, 7 days after starting enteral nutrition, 14 days after starting enteral nutrition
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exocrine Pancreatic Enzyme in people with Critically Ill and Enteral Feeding, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 8 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Oh (+82-2-2072-3538, faun1226@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of Phase angle (°) (time frame: Baseline, 7 days after starting enteral nutrition, 14 days after starting enteral nutrition). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2021.