Ignite Creation Date:
2025-12-25 @ 4:12 AM
Ignite Modification Date:
2026-02-24 @ 2:12 PM
Study NCT ID:
NCT01882920
Status:
COMPLETED
Last Update Posted:
2017-04-26
First Post:
2013-06-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Goal Directed Therapy (GDT) in Cytoreductive Surgery (CRS) and Hyperthermic Intra Peritoneal Chemotherapy (Hipec)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000077330', 'term': 'Saline Solution'}, {'id': 'D000077325', 'term': "Ringer's Lactate"}, {'id': 'D000077331', 'term': "Ringer's Solution"}], 'ancestors': [{'id': 'D000077324', 'term': 'Crystalloid Solutions'}, {'id': 'D007552', 'term': 'Isotonic Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-04', 'completionDateStruct': {'date': '2012-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-04-25', 'studyFirstSubmitDate': '2013-06-10', 'studyFirstSubmitQcDate': '2013-06-20', 'lastUpdatePostDateStruct': {'date': '2017-04-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-06-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'length of hospital stay', 'timeFrame': '4 weeks'}], 'primaryOutcomes': [{'measure': 'rate of abdominal complications', 'timeFrame': '90 day postoperative complication'}], 'secondaryOutcomes': [{'measure': 'Overall Survival', 'timeFrame': '90 day overall survival'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Cytoreductive surgery', 'hyperthermic intraperitoneal chemotherapy', 'Goal directed fluid therapy'], 'conditions': ['Primary Peritoneal Neoplasm', 'Secondary Peritoneal Neoplasm']}, 'descriptionModule': {'briefSummary': 'The aim of the study is to assess whether in cytoreductive surgery (CRS) and hyperthermic intraperitoneal chemotherapy (HIPEC) the use of a protocol of intravenous fluid therapy combined with goal directed fluid therapy (GDT) is associated with a significant change in morbidity, length of hospital stay and mortality compared to a standard fluid therapy. Patients undergoing CRS and hipec are randomly divided into two treatment groups. The GDT group receive fluid intravenous therapy according to a specific treatment protocol guided by monitored hemodynamic parameters assessed using the arterial pressure signal monitoring to assess stroke volume and cardiac output via an automated pulse contour analysis (Flotrac/Vigileo®); the control group receive the standard fluid therapy (crystalloid and colloid). Fluid therapy regimen is free in the control group and targeted in the GDT group. In both groups, the investigators evaluate the incidence of major abdominal and systemic complications, the total duration of hospital stay, mortality, the total amount of fluids administered, their breakdown (crystalloid/colloid) and the total number of colloid boluses administered.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients selected for Cytoreductive surgery and hyperthermic intraperitoneal chemotherapy\n\nExclusion Criteria:\n\n* Patients under the age of 18, patients with hemodynamically significant aortic regurgitation and heart rhythm disorders'}, 'identificationModule': {'nctId': 'NCT01882920', 'briefTitle': 'Goal Directed Therapy (GDT) in Cytoreductive Surgery (CRS) and Hyperthermic Intra Peritoneal Chemotherapy (Hipec)', 'organization': {'class': 'OTHER', 'fullName': 'Regina Elena Cancer Institute'}, 'officialTitle': 'Cytoreductive Surgery With Hyperthermic Intra-Peritoneal Chemotherapy (HIPEC) - Goal Directed Therapy vs. Standard Fluid Therapy. Prospective Randomized Study', 'orgStudyIdInfo': {'id': '89/10'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Goal directed therapy intravenous restricitve fluid protocol', 'interventionNames': ['Drug: Goal Directed Intravenous Restrictive Fluid Therapy']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control arm', 'interventionNames': ['Drug: Conventional Intravenous Fluid therapy']}], 'interventions': [{'name': 'Goal Directed Intravenous Restrictive Fluid Therapy', 'type': 'DRUG', 'otherNames': ['Normal Saline', "Ringer's lactate", "Ringer's solution", 'Hydroxyethyl starch 130/0,4 (HES 130,04)', 'Automated pulse contour'], 'description': "Basal infusion of crystalloids (normal saline,Ringer's lactate,Ringer's solution) at 4 ml/kg/h and boluses of colloids (HES 130/0.4 ) for values of cardiac index (CI) \\<2.5 l/min/m2, stroke volume index (SVI) \\< 35 SVI ml/m2 and stroke volume variation (SVV)\\> 15%. In the case of CI \\<2.5 l/min/m2 and SVI \\<35 ml/m2 with SVV \\< 15%, an infusion with dopamine was initiated.", 'armGroupLabels': ['Goal directed therapy intravenous restricitve fluid protocol']}, {'name': 'Conventional Intravenous Fluid therapy', 'type': 'DRUG', 'otherNames': ['Normal saline', "Ringer's lactate", "Ringer's solution"], 'description': "Basal infusion of crystalloid (normal saline,Ringer's lactate,Ringer's solution)variable from 4 to 12 ml/kg/hour.", 'armGroupLabels': ['Control arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '00144', 'city': 'Rome', 'country': 'Italy', 'facility': 'Regina Elena CI', 'geoPoint': {'lat': 41.89193, 'lon': 12.51133}}], 'overallOfficials': [{'name': 'Ester Forastiere, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Regina Elena CI'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Regina Elena Cancer Institute', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'M.D., Chief of Critical Area Department', 'investigatorFullName': 'Ester Forastiere', 'investigatorAffiliation': 'Regina Elena Cancer Institute'}}}}