Ignite Creation Date:
2025-12-24 @ 10:13 PM
Ignite Modification Date:
2026-01-01 @ 9:25 PM
Study NCT ID:
NCT03113435
Status:
RECRUITING
Last Update Posted:
2025-03-11
First Post:
2017-04-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Patient Management During Major Abdominal Surgery: an Oxygen Consumption Protocol Compared to Standard Approach
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 76}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2018-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2026-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-10', 'studyFirstSubmitDate': '2017-04-10', 'studyFirstSubmitQcDate': '2017-04-12', 'lastUpdatePostDateStruct': {'date': '2025-03-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-04-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-07-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Perioperative fluid balance', 'timeFrame': 'surgery', 'description': 'Perioperative fluid balance'}], 'secondaryOutcomes': [{'measure': 'Survival at 28 days', 'timeFrame': '28 days after surgery', 'description': 'Patients who survived at 28 days'}, {'measure': 'Survival at hospital discharge', 'timeFrame': '1 day (Hospital discharge)', 'description': 'Patient who survived at hospital discharge'}, {'measure': 'Post-operative complication', 'timeFrame': '1 day (Hospital discharge)', 'description': 'Increase in TnI, need for mechanical ventilation, infection, ICU admission, anastomotic leak, bleeding, AKI'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['CO2 gap', 'oxygen consumption', 'Stroke volume optimization'], 'conditions': ['Hemodynamic Instability']}, 'descriptionModule': {'briefSummary': 'This study compares the actual standard of care with a new protocol to guide hemodynamic optimization during major abdominal surgery, which is more tailored on patient real needs. During general anesthesia metabolic needs of the body are markedly reduced and increase in CO may not be necessary. In addition, excessive fluid administration has been related to worse post-operative outcomes. We divide patients into three groups: the standard treatment group, the NICE protocol group and the intervention group. In this group we use the v-aCO2/CaO2-CvO2 as marker of tissue ability to increase their oxygen consumption in response to increased O2 delivery, and based on this index the administration of fluid. The principal aim is to optimize functional hemodynamics in order to reduce the fluid balance at the end of the surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients aged \\> 18 years\n* acquisition of written informed consent\n* Major abdominal surgery (major gastrointestinal surgery: DCP, gastrectomy, Miles, emicolectomy; gynecologic surgery: oncologic surgery) Surgery times ≥ 3 hours\n\nExclusion Criteria:\n\n* Absolute contraindication to CVC placement\n* pregnant women\n* hepatic surgery\n* laparoscopic surgery\n* Major vascular surgery\n* Dialysis treatment and kidney transplant surgery\n* Severe heart failure (EF ≤ 35%)\n* Emergency surgery'}, 'identificationModule': {'nctId': 'NCT03113435', 'acronym': 'HEART-CORE', 'briefTitle': 'Patient Management During Major Abdominal Surgery: an Oxygen Consumption Protocol Compared to Standard Approach', 'organization': {'class': 'OTHER', 'fullName': 'Fondazione Policlinico Universitario Agostino Gemelli IRCCS'}, 'officialTitle': 'Patient Management During Major Abdominal Surgery: the Impact of a Hemodynamic Approach Oriented to Oxygen Consumption Optimization Compared to Standard Approach Targeting Preload-dependency and a Clinically-guided Strategy', 'orgStudyIdInfo': {'id': '1305'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Standard', 'description': 'In this group standard care will be provided to patients undergoing major abdominal surgery, regarding hemodynamic optimization'}, {'type': 'ACTIVE_COMPARATOR', 'label': 'NICE group', 'description': 'In this arm patients will be treated according to stroke volume optimization described in NICE program', 'interventionNames': ['Other: Oxygen consumption optimization']}, {'type': 'EXPERIMENTAL', 'label': 'Oxygen consumption group', 'description': 'In this arm patients will receive hemodynamic optimization based on their oxygen consumption need', 'interventionNames': ['Other: Oxygen consumption optimization']}], 'interventions': [{'name': 'Oxygen consumption optimization', 'type': 'OTHER', 'description': 'hemodynamic stability will be achieved through exploration of oxygen consumption need of the patient based on CO2gap/CaO2-CvO2 ratio', 'armGroupLabels': ['NICE group', 'Oxygen consumption group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '00168', 'city': 'Roma', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': "Antonio M Dell'Anna, MD", 'role': 'CONTACT', 'email': 'antoniomaria.dellanna@policlinicogemelli.it', 'phone': '+390630154490'}], 'facility': 'Fondazione Policlinico A. Gemelli IRCCS', 'geoPoint': {'lat': 44.99364, 'lon': 11.10642}}], 'centralContacts': [{'name': "Antonio M Dell'Anna, MD", 'role': 'CONTACT', 'email': 'anthosdel@yahoo.it', 'phone': '+390630154490'}], 'overallOfficials': [{'name': "Antonio M Dell'Anna, MD", 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fondazione Policlinico Universitario A. Gemelli'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fondazione Policlinico Universitario Agostino Gemelli IRCCS', 'class': 'OTHER'}, 'collaborators': [{'name': 'Flavia Torrini', 'class': 'UNKNOWN'}, {'name': 'Alessandra Bisanti', 'class': 'UNKNOWN'}, {'name': 'Eleonora Filipponi', 'class': 'UNKNOWN'}, {'name': 'Domenica Luca Grieco', 'class': 'UNKNOWN'}, {'name': 'Massimo Antonelli', 'class': 'UNKNOWN'}, {'name': 'Liliana Sollazzi', 'class': 'UNKNOWN'}, {'name': 'Valter Perilli', 'class': 'UNKNOWN'}, {'name': 'Andrea Russo', 'class': 'UNKNOWN'}, {'name': 'Pierpaolo Ciocchetti', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': "Antonio Maria Dell'Anna", 'investigatorAffiliation': 'Fondazione Policlinico Universitario Agostino Gemelli IRCCS'}}}}