Ignite Creation Date:
2025-12-24 @ 11:13 PM
Ignite Modification Date:
2026-02-24 @ 2:07 PM
Study NCT ID:
NCT01946269
Status:
UNKNOWN
Last Update Posted:
2013-09-19
First Post:
2013-09-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Goal-Directed Therapy in Cancer Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C077194', 'term': 'AIEOP acute lymphoblastic leukemia protocol'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 128}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2013-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-09', 'completionDateStruct': {'date': '2014-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2013-09-18', 'studyFirstSubmitDate': '2013-09-16', 'studyFirstSubmitQcDate': '2013-09-18', 'lastUpdatePostDateStruct': {'date': '2013-09-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-09-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Composite endpoint of death or major postoperative complications', 'timeFrame': '30 days after randomization', 'description': 'Death or one of the following complications: stroke, renal failure, respiratory complications, cardiovascular complications, deep wound infection and reoperation for any reason.'}], 'secondaryOutcomes': [{'measure': 'Duration of ICU stay and hospital stay', 'timeFrame': '30 days after randomization', 'description': 'To compare the number of days of ICU stay and hospital stay between groups.'}, {'measure': 'Tissue hypoperfusion markers', 'timeFrame': '7 days after randomization', 'description': 'To compare levels of DO2, lactate, ScvO2, base excess and venous to arterial carbon dioxide difference between groups.'}, {'measure': 'Daily SOFA score', 'timeFrame': '7 days after randomization', 'description': 'Daily sequential organ failure assessment score within the first 7 days after randomization'}, {'measure': 'Cardiovascular complications', 'timeFrame': '30 days after randomization', 'description': 'To compare the incidence of cardiovascular complications between groups. Cardiovascular complications will be defined as myocardial ischemia, acute decompensated heart failure, mesenteric ischemia, pulmonary thromboembolism and peripheral vascular ischemia.'}, {'measure': 'Respiratory complications', 'timeFrame': '30 days after randomization', 'description': 'Respiratory complication will be defined as acute distress respiratory syndrome according to Berlin criteria'}, {'measure': 'Severe Renal complication', 'timeFrame': '30 days after randomization', 'description': 'Severe renal complication will be defined as renal failure according to Acute Kidney Injury Network (AKIN) stage 3.'}, {'measure': 'Neurological complications', 'timeFrame': '30 days after randomization', 'description': 'To compare the incidence of stroke between groups within 30 days after randomization.'}, {'measure': 'Severe infectious complications', 'timeFrame': '30 days after randomization', 'description': 'To compare the incidence, between groups, of infectious complications defined as a new septic shock.'}, {'measure': 'Surgical complications', 'timeFrame': '30 days after randomization', 'description': 'To compare the incidence between groups of surgical complication. Surgical complication will be defined as reoperation due to any reason, hospital readmission or death'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Postoperative Care']}, 'referencesModule': {'references': [{'pmid': '29792232', 'type': 'DERIVED', 'citation': 'Gerent ARM, Almeida JP, Fominskiy E, Landoni G, de Oliveira GQ, Rizk SI, Fukushima JT, Simoes CM, Ribeiro U Jr, Park CL, Nakamura RE, Franco RA, Candido PI, Tavares CR, Camara L, Dos Santos Rocha Ferreira G, de Almeida EPM, Filho RK, Galas FRBG, Hajjar LA. Effect of postoperative goal-directed therapy in cancer patients undergoing high-risk surgery: a randomized clinical trial and meta-analysis. Crit Care. 2018 May 23;22(1):133. doi: 10.1186/s13054-018-2055-4.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether a goal-directed resuscitation therapy within the first 8 hours after major abdominal cancer surgery reduces postoperative complications compared to a standard therapy.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients admitted to ICU in immediate postoperatory of major abdominal surgery for cancer treatment\n* Age over 18 years-old\n\nExclusion Criteria:\n\n* Weight under 55 kilograms or over 140 kilograms;\n* Contra-indication for invasive hemodynamic monitoring;\n* Expected ICU permanence less than 24 hours;\n* Active bleeding\n* Vasoplegic shock with noradrenaline dose higher than 1mcg/kg/min\n* Enrolled in other study\n* Refuse to consent'}, 'identificationModule': {'nctId': 'NCT01946269', 'acronym': 'GRICS II', 'briefTitle': 'Goal-Directed Therapy in Cancer Surgery', 'organization': {'class': 'OTHER', 'fullName': 'University of Sao Paulo'}, 'officialTitle': 'Goal-directed Resuscitation in High-risk Patients Undergoing Major Cancer Surgery: a Controlled and Randomized Study', 'orgStudyIdInfo': {'id': 'GRICS-02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Standard group', 'interventionNames': ['Other: Standard protocol']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Goal-directed therapy (GDT) protocol', 'interventionNames': ['Other: Goal-directed Resuscitation Therapy (GDT)']}], 'interventions': [{'name': 'Goal-directed Resuscitation Therapy (GDT)', 'type': 'OTHER', 'description': "* A target value of a cardiac index (CI) greater than 2.5 L/min/m2 and a mean arterial pressure of 70 mmHg will be sought.\n* The first step will be fluid resuscitation with 200ml aliquots of Lactated Ringer's solution plus human albumin 20% 50 mL whenever the CI is lower than 2.5 L/min/m2. The fluid challenge will be stopped if the CVP rises by more than 4 mmHg during the infusion period or CI increases less than 10%.\n* When the CI is lower than or equal to 2.5L/min/m2 despite of fluid challenge, dobutamine will be initiated with increasing doses up to 20mcg/kg/min.\n* The final step will be red blood transfusion to reach a hematocrit higher than 28%.\n* If necessary, norepinephrine infusion will be used to maintain a mean arterial pressure above 70 mmHg.", 'armGroupLabels': ['Goal-directed therapy (GDT) protocol']}, {'name': 'Standard protocol', 'type': 'OTHER', 'description': 'The control group will be managed by the surgical ICU staff in the postoperative period according to institutional protocol of hemodynamic monitoring.', 'armGroupLabels': ['Standard group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '01246000', 'city': 'São Paulo', 'state': 'São Paulo', 'status': 'RECRUITING', 'country': 'Brazil', 'contacts': [{'name': 'Aline Müller, MD', 'role': 'CONTACT', 'email': 'dra.alinemuller@gmail.com', 'phone': '55-11-974130225'}, {'name': 'Aline Müller, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Ludhmila Hajjar, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Intensive Care Unit of the Cancer Institute of Sao Paulo State', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}], 'centralContacts': [{'name': 'Aline Müller, MD', 'role': 'CONTACT', 'email': 'dra.alinemuller@gmail.com', 'phone': '55-11-974130225'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Sao Paulo', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Ludhmila Abrahão Hajjar', 'investigatorAffiliation': 'University of Sao Paulo'}}}}