Ignite Creation Date:
2025-12-24 @ 4:30 PM
Ignite Modification Date:
2026-01-01 @ 8:03 AM
Study NCT ID:
NCT01974466
Status:
UNKNOWN
Last Update Posted:
2013-11-19
First Post:
2013-10-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Fluid Resuscitation Goal in Early Stage of Severe Acute Pancreatitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010195', 'term': 'Pancreatitis'}], 'ancestors': [{'id': 'D010182', 'term': 'Pancreatic Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2013-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-11', 'completionDateStruct': {'date': '2017-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2013-11-18', 'studyFirstSubmitDate': '2013-10-26', 'studyFirstSubmitQcDate': '2013-10-26', 'lastUpdatePostDateStruct': {'date': '2013-11-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-11-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'respiratory failure', 'timeFrame': '14days'}], 'primaryOutcomes': [{'measure': 'Mortality', 'timeFrame': '28day'}], 'secondaryOutcomes': [{'measure': 'intra-abdominal Hypertension', 'timeFrame': '7 days'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['pancreatitis', 'resuscitation goal'], 'conditions': ['Pancreatitis']}, 'referencesModule': {'references': [{'pmid': '19187641', 'type': 'BACKGROUND', 'citation': 'Mao EQ, Tang YQ, Fei J, Qin S, Wu J, Li L, Min D, Zhang SD. Fluid therapy for severe acute pancreatitis in acute response stage. Chin Med J (Engl). 2009 Jan 20;122(2):169-73.'}]}, 'descriptionModule': {'briefSummary': 'To compare different goals of fluid resuscitation in early stage of acute pancreatitis', 'detailedDescription': 'With regard to study of sepsis and several studies of SAP demonstrating the deleterious effects of fluid loss and haemoconcentration within the first 24h after admission（or onset of abdominal pain）, early goal-directed fluid resuscitation has the potential of improving outcome also in SAP. But the goal of fluid resuscitation remained controversial.Several criteria of fluid resuscitation had been described. Ours had been described in previous study, and had shown a ideal result with less incidence of abdominal compartment syndrome and higher survival rate. This study aims to determine a better goal of fluid resuscitation in severe acute pancreatitis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 1\\. Diagnosis of pancreatitis: Typical pain increase in serum lipase or amylase 2. Onset of abdominal pain within \\<=72h before admission 3. moderate severe or severe acute pancreatitis according to Atlanta criteria revisited in 2012 4. Evidence of \\>= 1 predictor of fluid resuscitation: Haematocrit \\>44% (male) or \\>40% (female), respectively Lactate\\>4mmol/L; heart rate\\>120bpm; urine \\<0.5ml/kg/h for 6 hour; Mean arterial pressure\\>85 or \\<60 mmHg\n\nExclusion Criteria:\n\n* 1\\. Pregnancy 2. New York Heart Association classification \\>II 3. With pacemaker implantation 4. chronic obstructive pulmonary disease 5. chronic kidney disease 6. Pre-existing disease with life expectancy \\< 3 months'}, 'identificationModule': {'nctId': 'NCT01974466', 'briefTitle': 'Fluid Resuscitation Goal in Early Stage of Severe Acute Pancreatitis', 'organization': {'class': 'OTHER', 'fullName': 'Ruijin Hospital'}, 'officialTitle': 'Fluid Resuscitation Goal in Early Stage of Severe Acute Pancreatitis', 'orgStudyIdInfo': {'id': 'RJpancreatitis01'}, 'secondaryIdInfos': [{'id': 'RJpancreatitis01', 'type': 'REGISTRY', 'domain': 'RuijinH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Goal A', 'description': 'controled fluid therapy: 5\\~10ml/kg/hr fulfillment of two or more of four criteria:\n\n1. heart rate \\<120 beats/min,\n2. mean arterial blood pressure 65-85 mm Hg,\n3. urine output ≥1 ml/kg /h\n4. Hematocrit ≤35%.', 'interventionNames': ['Other: Goal A']}, {'type': 'OTHER', 'label': 'Goal B', 'description': 'controled fluid therapy: 5\\~10ml/kg/hr fulfillment of all of the following criteria:\n\n1 central venous pressure8-12 mmHg , 2.mean arterial pressure 65-85 mm Hg, 3. urine output ≥0.5 ml/kg/h 4. ScvO2 ≤70%', 'interventionNames': ['Other: Goal B']}], 'interventions': [{'name': 'Goal A', 'type': 'OTHER', 'otherNames': ['Ruijin pancreatitis goal'], 'description': 'controled fluid therapy：10\\~5ml/kg/h，crystalloid vs colloid 2:1 resuscitation target： fulfillment of two or more of four criteria:1. HR \\<120 beats/min, 2.MAP 65-85 mm Hg, 3. urine output ≥1 ml/kg /h 4. HCT ≤35%.', 'armGroupLabels': ['Goal A']}, {'name': 'Goal B', 'type': 'OTHER', 'otherNames': ['Sepsis goal'], 'description': 'controled fluid therapy：10\\~5ml/kg/h，crystalloid vs colloid 2:1 resuscitation target： fulfillment of all of the following criteria:\n\n1 CVP 8-12 mmHg , 2.MAP 65-85 mm Hg, 3. urine output ≥0.5 ml/kg/h 4. ScvO2 ≤70%', 'armGroupLabels': ['Goal B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20000', 'city': 'Shanghai', 'state': 'Shanghai Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'zhen er chen, PhD', 'role': 'CONTACT', 'email': 'clockming@live.com', 'phone': '64370045', 'phoneExt': '665570'}, {'name': 'Zhen er chen, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Ruijin', 'geoPoint': {'lat': 31.22222, 'lon': 121.45806}}], 'centralContacts': [{'name': 'Zhen er Chen, PhD', 'role': 'CONTACT', 'email': 'chenerzhen@hotmail.com', 'phone': '64370045', 'phoneExt': '665520'}], 'overallOfficials': [{'name': 'Qiang En Mao, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Emergency intensive care unit of Ruijin Hospital'}, {'name': 'Ming zhong, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'doctor'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ruijin Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'RenJi Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Erzhen Chen', 'investigatorAffiliation': 'Ruijin Hospital'}}}}