Ignite Creation Date:
2025-12-24 @ 11:57 PM
Ignite Modification Date:
2026-02-25 @ 7:03 PM
Study NCT ID:
NCT01933451
Status:
TERMINATED
Last Update Posted:
2013-09-02
First Post:
2013-03-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Outcome Study of Restrictive vs. Liberal Intraoperative Fluid Management Guided by PPV in Esophagectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 7}}, 'statusModule': {'whyStopped': 'The grant for this study was not allowed.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2013-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-03', 'completionDateStruct': {'date': '2013-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-08-28', 'studyFirstSubmitDate': '2013-03-19', 'studyFirstSubmitQcDate': '2013-08-28', 'lastUpdatePostDateStruct': {'date': '2013-09-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-09-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'postoperative lung function, kidney function, inflammatory response', 'timeFrame': 'from introperative to postoperative day 2', 'description': 'plasma creatinine, CRP, lactate, NGAL, IL-6, IL-8'}], 'secondaryOutcomes': [{'measure': 'postoperative short-term outcome', 'timeFrame': 'the duration of hospital stay, about 4 weeks', 'description': 'Respiratory complication, cardiovascular complication, acute renal failure, another complications'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['fluid therapy', 'Intraoperative care', 'Patient Outcome Assessment', 'pulse pressure variation', 'restrictive fluid therapy', 'goal-directed fluid therapy', 'esophagectomy'], 'conditions': ['Other Complications of Esophagostomy']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether intraoperative restrictive fluid management guided by pulse pressure variation produces a better effect on the postoperative lung function, kidney function, inflammatory response and short-term outcome after esophagectomy and reconstruction.', 'detailedDescription': 'Measurements: intraoperative Lung injury score, Lung water index, Pulmonary vascular Permeability Index Measurements: intraoperative and postoperative Plasma creatine, C reactive protein (CRP), lactate, Neutrophil gelatinase-associated lipocalin (NGAL), Interleukin-6 (IL-6), Interleukin-8 (IL-8)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients undergoing esophagectomy and reconstruction\n\nExclusion Criteria:\n\n* ASA score \\>= 3, (American Society of Anesthesiologist physical status classification system)\n* arrythmia, atrial fibrillation\n* lung diseases, such as COPD (chronic obstructive pulmonary disease); lung function test showed moderate to severe ventilation defect\n* plasma creatinine level above 1.5 mg/dl'}, 'identificationModule': {'nctId': 'NCT01933451', 'acronym': 'PPV', 'briefTitle': 'Outcome Study of Restrictive vs. Liberal Intraoperative Fluid Management Guided by PPV in Esophagectomy', 'organization': {'class': 'OTHER', 'fullName': 'National Taiwan University Hospital'}, 'officialTitle': 'Postoperative Lung Function, Kidney Function, Inflammatory Response and Short-term Outcome After Esophagectomy and Reconstruction: Intraoperative Fluid Management Controlled With Lower and Higher Pulse Pressure Variation', 'orgStudyIdInfo': {'id': '201211078RIB'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Restrictive intraoperative fluid therapy', 'description': 'To Keep intraoperative pulse pressure variation above 18%.', 'interventionNames': ['Other: Intraoperative fluid therapy']}, {'type': 'OTHER', 'label': 'Liberal intraoperative fluid therapy', 'description': 'To keep intraoperative pulse pressure variation below 13%.', 'interventionNames': ['Other: Intraoperative fluid therapy']}], 'interventions': [{'name': 'Intraoperative fluid therapy', 'type': 'OTHER', 'description': 'Intraoperative fluid therapy is directed by pulse pressure variation to a setting value, above 18% or below 13%.', 'armGroupLabels': ['Liberal intraoperative fluid therapy', 'Restrictive intraoperative fluid therapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100', 'city': 'Taipei', 'country': 'Taiwan', 'facility': 'Department of Anesthesiology, National Taiwan University Hospital', 'geoPoint': {'lat': 25.05306, 'lon': 121.52639}}], 'overallOfficials': [{'name': 'Ya-Uyng Cheng, MD. PHD.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'chengyj@ntu.edu.tw'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'National Taiwan University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}