Ignite Creation Date:
2025-12-26 @ 10:36 AM
Ignite Modification Date:
2026-01-01 @ 3:19 AM
Study NCT ID:
NCT05112328
Status:
RECRUITING
Last Update Posted:
2021-11-08
First Post:
2021-10-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effects of Pancreatic Enzyme Supplementation in Critically Ill Patients on Enteral Feeding
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016638', 'term': 'Critical Illness'}, {'id': 'D010188', 'term': 'Exocrine Pancreatic Insufficiency'}], 'ancestors': [{'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 170}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-07-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-11', 'completionDateStruct': {'date': '2026-07-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-11-04', 'studyFirstSubmitDate': '2021-10-07', 'studyFirstSubmitQcDate': '2021-11-04', 'lastUpdatePostDateStruct': {'date': '2021-11-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-11-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-07-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change of Phase angle (°)', 'timeFrame': 'Baseline, 7 days after starting enteral nutrition, 14 days after starting enteral nutrition', 'description': 'Change from Baseline Phase angle (°) at 2 weeks or discharge'}], 'secondaryOutcomes': [{'measure': 'Skeletal Muscle Mass (SMM) (kg)', 'timeFrame': 'Baseline, 7 days after starting enteral nutrition, 14 days after starting enteral nutrition', 'description': 'Skeletal Muscle Mass (SMM) (kg)'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Critically Ill', 'Enteral Feeding', 'Exocrine Pancreatic Insufficiency']}, 'descriptionModule': {'briefSummary': 'Determine the effect of high-dose pancreatic enzyme supplementation on nutritional indicators and clinical course in critically ill patients undergoing enteral nutrition.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults 19 years and older\n* Hospitalized in the surgical/medical intensive care unit of the Seoul National University Hospital\n* Enteral nutrition\n* Patients who consented to this study\n* Patients with risk factors for pancreatic exocrine dysfunction\n\n * Shock (Norepinephrine)\n * Sepsis (3 rd definition of sepsis)\n * Diabetes\n * Cardiac arrest\n * hyperlactatemia serum lactate \\> 2 mmol/L)\n * Mechanical ventilation\n * Continuous renal replacement therapy\n\nExclusion Criteria:\n\n* chronic pancreatitis\n* unresectable pancreatic cancer\n* History of pancreatectomy\n* Underlying diseases in which the effect of Exocrine pancreatic enzyme administration is difficult to show\n\n * Inflammatory bowel disease\n * Short bowel syndrome'}, 'identificationModule': {'nctId': 'NCT05112328', 'acronym': 'PREZENT', 'briefTitle': 'The Effects of Pancreatic Enzyme Supplementation in Critically Ill Patients on Enteral Feeding', 'organization': {'class': 'OTHER', 'fullName': 'Seoul National University Hospital'}, 'officialTitle': 'The Effects of Pancreatic Enzyme Supplementation in Critically Ill Patients on Enteral Feeding: Prospective Randomized Controlled Trial', 'orgStudyIdInfo': {'id': '2008-185-1153'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention', 'description': 'Exocrine Pacancreatic enzyme(Norzyme Capsule 40000 capsules) after meals 3 times a day', 'interventionNames': ['Drug: Exocrine Pancreatic Enzyme']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control', 'description': 'Placebo after meals 3 times a day', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Exocrine Pancreatic Enzyme', 'type': 'DRUG', 'otherNames': ['Norzyme'], 'description': 'Pancreatic enzyme supplementation for critically ill patients on enteral nutrition', 'armGroupLabels': ['Intervention']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo of Pancreatic enzyme for critically ill patients on enteral nutrition', 'armGroupLabels': ['Control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '03080', 'city': 'Seoul', 'state': 'Jongno-gu', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Seoul National University Hospital', 'role': 'CONTACT'}], 'facility': 'Seoul National University Hospital', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}], 'centralContacts': [{'name': 'Oh', 'role': 'CONTACT', 'email': 'faun1226@gmail.com', 'phone': '+82-2-2072-3538'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seoul National University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Assistant Professor', 'investigatorFullName': 'Seung-Young Oh', 'investigatorAffiliation': 'Seoul National University Hospital'}}}}