Ignite Creation Date:
2025-12-24 @ 7:22 PM
Ignite Modification Date:
2025-12-25 @ 5:01 PM
Study NCT ID:
NCT01654003
Status:
TERMINATED
Last Update Posted:
2016-05-13
First Post:
2012-07-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Impact of Early Goal-directed Fluid Therapy in Septic Patients Undergoing Emergency Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018805', 'term': 'Sepsis'}, {'id': 'D004630', 'term': 'Emergencies'}], 'ancestors': [{'id': 'D007239', 'term': 'Infections'}, {'id': 'D018746', 'term': 'Systemic Inflammatory Response Syndrome'}, {'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D020969', 'term': 'Disease Attributes'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D059039', 'term': 'Standard of Care'}, {'id': 'D014662', 'term': 'Vasoconstrictor Agents'}, {'id': 'C451741', 'term': 'point 4 composite resin'}], 'ancestors': [{'id': 'D019984', 'term': 'Quality Indicators, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D002317', 'term': 'Cardiovascular Agents'}, {'id': 'D045506', 'term': 'Therapeutic Uses'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'whyStopped': 'recrutment difficulties', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2010-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-05', 'completionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-05-11', 'studyFirstSubmitDate': '2012-07-18', 'studyFirstSubmitQcDate': '2012-07-27', 'lastUpdatePostDateStruct': {'date': '2016-05-13', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-07-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Delta lactate', 'timeFrame': 'From randomization, for the duration of surgery and up to transfer from the operating room to the ICU or recovery room, an expected average of 6 hours.', 'description': 'The primary study endpoint will be the difference between the baseline arterial blood lactate at the time of randomization and the value of the arterial blood lactate at the time of transfer from the emergency operating room (∆ lactate).'}], 'secondaryOutcomes': [{'measure': 'Cardiovascular complications: myocardial infarct or congestive heart failure', 'timeFrame': 'Day 1, day 2, day 3 after randomization until hospital discharge or up to 28 days or death, whichever comes first', 'description': 'Clinical outcome and surrogate biomarkers (Troponin-I and pro-BNP: day 1-2-3) will be recorded by extracting this specific data from the electronic medical file, until discharge, death or up to 28 days, whichever comes first.'}, {'measure': 'Cerebral complications: stroke', 'timeFrame': 'Day 1, day 2, day 3 after randomization until hospital discharge or up to 28 days or death, whichever comes first.', 'description': 'Clinical outcomes at day 1-2-3 will be recorded by extracting this specific data from the electronic medical file, and until discharge, death or up to 28 days, whichever comes first.'}, {'measure': 'Pulmonary complications: ALI/ARDS, bronchopneumonia', 'timeFrame': 'Day 1, day 2, day 3 after randomization until hospital discharge or up to 28 days or death, whichever comes first.', 'description': 'Clinical outcomes at day 1-2-3 will be recorded by extracting this specific data from the electronic medical file, and until discharge, death or up to 28 days, whichever comes first.'}, {'measure': 'Pulmonary complications: respiratory insufficiency necessitating re-intubation', 'timeFrame': 'Day 1, day 2, day 3 after randomization until hospital discharge or up to 28 days or death, whichever comes first.', 'description': 'Clinical outcomes at day 1-2-3 will be recorded by extracting this specific data from the electronic medical file, and until discharge, death or up to 28 days, whichever comes first.'}, {'measure': 'Surgical complications: re-operation for bleeding or infection', 'timeFrame': 'Day 1, day 2, day 3 after randomization until hospital discharge or up to 28 days or death, whichever comes first.', 'description': 'Clinical outcomes at day 1-2-3 will be recorded by extracting this specific data from the electronic medical file, and until discharge, death or up to 28 days, whichever comes first.'}, {'measure': 'Renal complications: infection, urosepsis or renal insufficiency', 'timeFrame': 'Day 1, day 2, day 3 after randomization until hospital discharge or up to 28 days or death, whichever comes first', 'description': 'Clinical outcome and surrogate biomarkers (Riffle score, creatinine: day 1-2-3) will be recorded by extracting this specific data from the electronic medical file, until discharge, death or up to 28 days, whichever comes first.'}, {'measure': 'Duration of post-operative mechanical ventilation: in hours', 'timeFrame': 'Day 1, day 2, day 3 after randomization until hospital discharge or up to 28 days or death, whichever comes first.', 'description': 'Clinical outcomes at day 1-2-3 will be recorded by extracting this specific data from the electronic medical file, and until discharge, death or up to 28 days, whichever comes first.'}, {'measure': 'Total duration of ventilation : days', 'timeFrame': 'Day 1, day 2, day 3 after randomization until hospital discharge or up to 28 days or death, whichever comes first', 'description': 'Clinical outcomes (ventilation free days) will be recorded by extracting this specific data from the electronic medical file, and until discharge, death or up to 28 days, whichever comes first.'}, {'measure': 'Length of stay in the ICU: in days', 'timeFrame': 'Day 1, day 2, day 3 after randomization until hospital discharge or up to 28 days or death, whichever comes first.'}, {'measure': 'Length of stay in hospital: in days', 'timeFrame': 'Day 1, day 2, day 3 after randomization until hospital discharge or up to 28 days or death, whichever comes first.'}, {'measure': 'Mortality', 'timeFrame': 'From randomization up to 28 days'}, {'measure': 'SOFA score measurement', 'timeFrame': 'From randomization : day 1, day 2, day 3'}, {'measure': 'Death', 'timeFrame': 'Day 1, day 2, day 3 after randomization until hospital discharge or up to 28 days or death, whichever comes first'}, {'measure': 'Number of unexpected ICU admission', 'timeFrame': 'From randomization up to 28 days'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Goal-directed therapy', 'severe sepsis', 'emergency surgery', 'vasopressor', 'dynamic flow-related parameters'], 'conditions': ['Severe Sepsis', 'Emergency', 'Surgery']}, 'descriptionModule': {'briefSummary': 'This study wants to compared the safety and efficacy of GDTs using standard pressure-related parameters vs. dynamic hemodynamic indices associated with fluid compartment monitoring, in septic patients requiring emergency surgery.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Adults \\> 18 years\n* Severe sepsis\\* as defined by the ACCCP/SCCM consensus conference\n* Need for emergent interventional procedure under general anesthesia with an expected duration \\> 120 min (in and out patients).\n\nExclusion Criteria:\n\n* Patients responding to early fluid resuscitation (20ml/kg) who don't require a CVC\n* Neurotrauma (Glasgow Coma Score \\< 12) and/ or medullar trauma\n* Known pregnancy or diagnosed by US or Ct-scan (\\> 14 weeks)\n* Sustained cardiac arrhythmia (see Logbook P8)\n* Known or diagnosed severe cardiac valvular dysfunction (stenosis, insufficiency) (see Logbook P8)\n* Known or diagnosed intracardiac shunt: interventricular or atrial defect (see Logbook P8)\n* Burn injury \\> 10%\n* Needed emergency thoracotomy or ABC resuscitation protocol\n* Pre-existing severe liver dysfunction(Child-Pugh class C)\n* Do-not-resuscitate order, died within 48h of admission"}, 'identificationModule': {'nctId': 'NCT01654003', 'briefTitle': 'Impact of Early Goal-directed Fluid Therapy in Septic Patients Undergoing Emergency Surgery', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Geneva'}, 'officialTitle': 'Impact of Early Goal-directed Fluid Therapy in Septic Patients Undergoing Emergency Surgery. A Prospective, Randomised, Open Trial', 'orgStudyIdInfo': {'id': 'NAC 09-044 B'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'CONTROL', 'description': 'In the CONTROL group, the administration of fluid (250-500ml crystalloids or colloids) and cardiovascular supportive drugs will be guided to maintain standard pressure-related parameters within a normal range: MAP \\> 65mmHg, HR \\< 90/min, CVP \\>8-12\\< cm H20, urinary output \\> 0.5 ml/kg/h. In line with the conventional approach, other physiological parameters will also be targeted: T° \\> 35.5°C, Sp02 \\> 95%, lactate \\< 2.5 mmol/L, normalisation of the BE. The maximal infused volume of hydroxyethyl starch (Voluven®) will be 33 ml/kg.\n\nAt the discretion of the attending anaesthesiologist with the FMH level, a pulmonary artery catheter, a transoesophageal Doppler flow probe or the PiCCO monitor will be inserted to complement the standard hemodynamic monitoring if deemed necessary.', 'interventionNames': ['Other: CONTROL']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'OPTIMIZED', 'description': 'In the OPTIMIZED group, the central venous catheter and the 4-French artery catheter (femoral or humeral access site) will be connected to a dedicated haemodynamic monitor (Pulsiocath, PV2024L; Pulsion Medical Systems AG, Munich, Germany).\n\nThe administration of fluid (250-500ml crystalloids or colloids) and cardiovascular supportive drugs will be guided by an algorithm taking into account standard parameters (HR, MAP, lactate, Hb), as well as static and dynamic volumetric parameters (SVI, CI, GEDVI, EVLWI, SVV, PPV, PVI).', 'interventionNames': ['Other: OPTIMIZED']}], 'interventions': [{'name': 'CONTROL', 'type': 'OTHER', 'otherNames': ['standard care', 'fluide therapy', 'vasopressor', 'sepsis'], 'description': 'In the CONTROL group, the administration of fluid (250-500ml crystalloids or colloids) and cardiovascular supportive drugs will be guided to maintain standard pressure-related parameters within a normal range: MAP \\> 65mmHg, HR \\< 90/min, CVP \\>8-12\\< cm H20, urinary output \\> 0.5 ml/kg/h. In line with the conventional approach, other physiological parameters will also be targeted: T° \\> 35.5°C, Sp02 \\> 95%, lactate \\< 2.5 mmol/L, normalisation of the BE. The maximal infused volume of hydroxyethyl starch (Voluven®) will be 33 ml/kg.', 'armGroupLabels': ['CONTROL']}, {'name': 'OPTIMIZED', 'type': 'OTHER', 'otherNames': ['GDT fluide therapy', 'Picco'], 'description': 'In the OPTIMIZED group, the haemodynamic monitor (Pulsiocath)will help to a goal-directed administration of fluid (250-500ml crystalloids or colloids).The cardiovascular supportive drugs will be guided by an algorithm taking into account standard parameters (HR, MAP, lactate, Hb), as well as static and dynamic volumetric parameters (SVI, CI, GEDVI, EVLWI, SVV, PPV, PVI).', 'armGroupLabels': ['OPTIMIZED']}]}, 'contactsLocationsModule': {'locations': [{'zip': '12011', 'city': 'Geneva', 'state': 'Canton of Geneva', 'country': 'Switzerland', 'facility': 'Hôpitaux Universitaires de Genève', 'geoPoint': {'lat': 46.20222, 'lon': 6.14569}}, {'zip': '1211', 'city': 'Geneva', 'state': 'Canton of Geneva', 'country': 'Switzerland', 'facility': 'Emergency operating room, Geneva Cantonal Hospital', 'geoPoint': {'lat': 46.20222, 'lon': 6.14569}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Geneva', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Pavlovic Gordana, MD', 'investigatorAffiliation': 'University Hospital, Geneva'}}}}