Ignite Creation Date:
2025-12-24 @ 4:15 PM
Ignite Modification Date:
2025-12-28 @ 3:42 PM
Study NCT ID:
NCT01507766
Status:
COMPLETED
Last Update Posted:
2012-11-16
First Post:
2012-01-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Correlations Between Early Enteral Nutrition and Intra-abdominal Pressure in Severe Acute Pancreatitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010195', 'term': 'Pancreatitis'}, {'id': 'D059325', 'term': 'Intra-Abdominal Hypertension'}], 'ancestors': [{'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D003161', 'term': 'Compartment Syndromes'}, {'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-11', 'completionDateStruct': {'date': '2011-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-11-15', 'studyFirstSubmitDate': '2012-01-03', 'studyFirstSubmitQcDate': '2012-01-10', 'lastUpdatePostDateStruct': {'date': '2012-11-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-01-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Enteral nutrition', 'timeFrame': '14 days', 'description': 'The caloric intake and tolerance of feeding were recorded daily after enteral nutrition was started'}, {'measure': 'Intra-abdominal pressure', 'timeFrame': '14 days', 'description': 'The value of intra-abdominal pressure (per 6 hours) and the incidence of intra-abdominal hypertension'}], 'secondaryOutcomes': [{'measure': 'Clinical outcome variables', 'timeFrame': '14 days', 'description': 'Hospital mortality; Duration of ICU stay; The development of multiple organ dysfunction syndrome and pancreatic infection; APACHEII score; SOFA score; CRP levels'}, {'measure': 'Immune parameters', 'timeFrame': '14 days', 'description': 'IgA, IgG, IgM, CD4+/CD8+T cell and HLA-DR'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['severe acute pancreatitis', 'intra-abdominal pressure', 'enteral nutrition'], 'conditions': ['Acute Pancreatitis', 'Intra-abdominal Hypertension']}, 'referencesModule': {'references': [{'pmid': '23674254', 'type': 'DERIVED', 'citation': 'Sun JK, Li WQ, Ke L, Tong ZH, Ni HB, Li G, Zhang LY, Nie Y, Wang XY, Ye XH, Li N, Li JS. Early enteral nutrition prevents intra-abdominal hypertension and reduces the severity of severe acute pancreatitis compared with delayed enteral nutrition: a prospective pilot study. World J Surg. 2013 Sep;37(9):2053-60. doi: 10.1007/s00268-013-2087-5.'}, {'pmid': '23431120', 'type': 'DERIVED', 'citation': 'Sun JK, Mu XW, Li WQ, Tong ZH, Li J, Zheng SY. Effects of early enteral nutrition on immune function of severe acute pancreatitis patients. World J Gastroenterol. 2013 Feb 14;19(6):917-22. doi: 10.3748/wjg.v19.i6.917.'}]}, 'descriptionModule': {'briefSummary': 'As an important management of severe acute pancreatitis (SAP), enteral nutrition (EN), especially early enteral nutrition (EEN) increases the blood flow of gut mucosa and stimulates the intestinal motility. Moreover, EEN maintains the gut integrity, prevents bacterial and endotoxin translocation and thereby theoretically reduces the incidence of infections. Therefore, EEN has the ability to reduce the infectious complications, length of hospital stay and mortality of patients with SAP.\n\nHowever, the role of EEN is considered to be influenced by intra-abdominal hypertension (IAH) in patients with SAP. The previous studies showed that gut was the most sensitive splanchnic organ to the increase of intra-abdominal pressure (IAP). When IAH occurs, it reduces the blood flow of gut, and then results in the development of intestinal ischemia and edema. The hypoxia and hypoperfusion of intestine leads to the increase of permeability of the intestinal mucosal barrier, and then leads to bacterial translocation. Therefore, IAH could result in the gastrointestinal dysfunction. Nevertheless, the different impacts of specific IAP values on the tolerance of EEN have not been reported.\n\nFurthermore, the effects of early enteral feeding on the IAP in SAP also remain unknown. Due to the severe inflammatory response of SAP, could EEN increase the burden of bowel, cause expansion of intestinal cavity, thus increase IAP? However, there were rare literatures up to date reporting the association between EEN and IAH in patients with SAP. Therefore, the present study aimed to investigate the influence of specific IAP on the tolerance of early enteral feeding, as well as the effects of EEN on IAP in SAP patients. Moreover, the impacts of EEN on the disease severity and clinical outcome of SAP were also researched.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The diagnosis of acute pancreatitis accords with the Atlanta criteria in 1992\n* Within 3 days from the onset of the disease\n* Hemodynamics stable\n\nExclusion Criteria:\n\n* Decompressive measures and enteral nutrition was performed before admission\n* Ileus of lower digestive tract\n* Pregnant pancreatitis\n* Chronic organs dysfunction\n* Immunodeficiency'}, 'identificationModule': {'nctId': 'NCT01507766', 'briefTitle': 'The Correlations Between Early Enteral Nutrition and Intra-abdominal Pressure in Severe Acute Pancreatitis', 'organization': {'class': 'OTHER', 'fullName': 'Nanjing University School of Medicine'}, 'officialTitle': 'The Correlations Between Early Enteral Nutrition and Intra-abdominal Pressure in Severe Acute Pancreatitis', 'orgStudyIdInfo': {'id': '110-85'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Early enteral nutrition', 'description': 'The enteral nutrition was started within 48h after admission', 'interventionNames': ['Drug: early enteral nutrition']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Delayed enteral nutrition', 'description': 'The enteral nutrition was started at the 8th day after admission', 'interventionNames': ['Drug: Delayed enteral nutrition']}], 'interventions': [{'name': 'early enteral nutrition', 'type': 'DRUG', 'description': 'The enteral nutrition was started within 48h after admission', 'armGroupLabels': ['Early enteral nutrition']}, {'name': 'Delayed enteral nutrition', 'type': 'DRUG', 'description': 'The enteral nutrition was started at the 8th day after admission', 'armGroupLabels': ['Delayed enteral nutrition']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Nanjing', 'state': 'Jiangsu', 'country': 'China', 'facility': 'Department of SICU, Research Institute of General Surgery , Jinling Hospital', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}], 'overallOfficials': [{'name': 'Wei-qin Li, M.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Jinlin Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nanjing University School of Medicine', 'class': 'OTHER'}, 'collaborators': [{'name': 'Jinling Hospital, China', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Jiakui Sun', 'investigatorAffiliation': 'Nanjing University School of Medicine'}}}}