Ignite Creation Date:
2025-12-24 @ 11:42 PM
Ignite Modification Date:
2025-12-25 @ 9:34 PM
Study NCT ID:
NCT04292951
Status:
COMPLETED
Last Update Posted:
2020-09-02
First Post:
2020-03-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Early Goal Directed Therapy in Cardiac Surgery
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D005440', 'term': 'Fluid Therapy'}], 'ancestors': [{'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'The patient is anesthetized, thus unaware type of treatment. The assessor is blinded of the monitor'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Group GDT: fluid and inotropic/vasoactive drugs management guided by FloTrac/EV1000 Group Control: fluid and inotropic/vasoactive drugs management guided by central venous pressure (CVP), blood pressure, heart rate, and clinical signs'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-08', 'completionDateStruct': {'date': '2020-07-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-08-31', 'studyFirstSubmitDate': '2020-03-01', 'studyFirstSubmitQcDate': '2020-03-01', 'lastUpdatePostDateStruct': {'date': '2020-09-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-03-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-06-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of inotropic/vaso active drugs requirement', 'timeFrame': 'up to Day 1 postoperatively', 'description': 'number of inotropic/vasoactive drugs required to maintain normal blood pressure and heart rate'}], 'secondaryOutcomes': [{'measure': 'ICU stay', 'timeFrame': 'up to day 10 postoperatively', 'description': 'number of hours admitted in ICU'}, {'measure': 'Lactate level', 'timeFrame': 'up to Day 1 postoperatively', 'description': 'serum lactate level'}, {'measure': 'Creatinine level', 'timeFrame': 'up to day 10 postoperatively', 'description': 'serum creatinine level'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Postoperative outcome', 'Goal directed therapy', 'Arterial pressure derived cardiac output'], 'conditions': ['Postoperative Outcome', 'ICU Stay']}, 'referencesModule': {'references': [{'pmid': '28817481', 'type': 'RESULT', 'citation': 'Bednarczyk JM, Fridfinnson JA, Kumar A, Blanchard L, Rabbani R, Bell D, Funk D, Turgeon AF, Abou-Setta AM, Zarychanski R. Incorporating Dynamic Assessment of Fluid Responsiveness Into Goal-Directed Therapy: A Systematic Review and Meta-Analysis. Crit Care Med. 2017 Sep;45(9):1538-1545. doi: 10.1097/CCM.0000000000002554.'}, {'pmid': '18182756', 'type': 'RESULT', 'citation': 'Kapoor PM, Kakani M, Chowdhury U, Choudhury M, Lakshmy, Kiran U. Early goal-directed therapy in moderate to high-risk cardiac surgery patients. Ann Card Anaesth. 2008 Jan-Jun;11(1):27-34. doi: 10.4103/0971-9784.38446.'}, {'pmid': '30077561', 'type': 'RESULT', 'citation': 'Kusaka Y, Ohchi F, Minami T. Evaluation of the Fourth-Generation FloTrac/Vigileo System in Comparison With the Intermittent Bolus Thermodilution Method in Patients Undergoing Cardiac Surgery. J Cardiothorac Vasc Anesth. 2019 Apr;33(4):953-960. doi: 10.1053/j.jvca.2018.06.017. Epub 2018 Jun 28.'}, {'pmid': '17822565', 'type': 'RESULT', 'citation': 'Lopes MR, Oliveira MA, Pereira VO, Lemos IP, Auler JO Jr, Michard F. Goal-directed fluid management based on pulse pressure variation monitoring during high-risk surgery: a pilot randomized controlled trial. Crit Care. 2007;11(5):R100. doi: 10.1186/cc6117.'}, {'pmid': '35989328', 'type': 'DERIVED', 'citation': 'Tribuddharat S, Sathitkarnmanee T, Ngamsaengsirisup K, Sornpirom S. Efficacy of early goal-directed therapy using FloTrac/EV1000 to improve postoperative outcomes in patients undergoing off-pump coronary artery bypass surgery: a randomized controlled trial. J Cardiothorac Surg. 2022 Aug 21;17(1):196. doi: 10.1186/s13019-022-01933-4.'}]}, 'descriptionModule': {'briefSummary': 'Early goal directed therapy (EGDT) based on information from arterial waveform derived cardiac output (APCO) FloTrac/EV1000 system has been proved to improve postoperative outcomes in patients undergoing major surgery. This system, however, has the limitation to be applied in open-chest surgery, especially cardiac surgery. The efficiency of FloTrac/EV1000 system to improve postoperative outcomes in cardiac surgery is still inconclusive.\n\nHypothesis: Intraoperative management in patients undergoing cardiac surgery guided by FloTrac/EV1000 system, compared with conventional protocol, results in better clinical outcomes.\n\nPrimary outcomes: Immediate postoperative inotropic/vasoactive drugs requirement.\n\nMethods: Adult patients undergoing cardiac surgery will be randomized into 2 groups: EGDT group managed by FloTrac/EV1000 system and Control group managed by conventional protocol.\n\nOutcome analyses: Compare the number of inotropic/vasoactive drugs requirement at the end of surgery, as well as intensive care unit (ICU) stay between both groups.', 'detailedDescription': 'Objective: To compare postoperative clinical outcome in adult patients undergoing cardiac surgery.\n\nPrimary outcome: Postoperative inotropic/vasoactive drugs reqirement.\n\nSecondary outcome: ICU stay.\n\nMethods: Eligible patients will be randomized to 2 groups. Both groups will be managed intraoperatively in the same way, except fluid and inotropic/vasoactive drugs management protocol. EGDT group will be managed according to information derived from FloTrac/EV1000 system, i.e., control stroke volume variation (SVV) 10-13% and give fluid when SVV \\> 13%, give inotropic to maintain cardiac index (CI) 2.5-4 L/min/m2, and give vasoactive drugs to maintain systemic vascular resistance index (SVRI) of 1,900-2,400 dynes-sec/cm-5/m2 . Control group will be managed using central venous pressure (CVP) protocol, i.e., control CVP 8-12 mmHg and give fluid when CVP \\< 8 mmHg, give inotropic/vasoactive drugs according to blood pressure and heart rate as well as clinical signs at the discretion of attending anesthesiologists.\n\nOutcome analyses: Postoperative number of inotropic/vasoactive drugs requirement as well as ICU stay of both groups will be compared using unpaired Student-t test or Mann-Whitney U test.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. 18-80 years old\n2. Patient has ischemic or valvular heart disease\n3. Scheduled for elective cardiac surgery\n4. New York Heart Association (NYHA) or American society of Anesthesiology (ASA) classification I-III\n5. Body mass index (BMI) 18-24 kg/m2\n6. Provided informed consent before surgery\n\nExclusion Criteria:\n\n1. Scheduled for emergency or redo surgery\n2. Difficulty (or contraindication to) placing a central venous catheter\n3. Inability to cooperate (e.g. mental disorder, disturbance of consciousness, mental retardation)\n4. Presence of blood-borne infectious disease (e.g. syphilis, acquired immunodeficiency'}, 'identificationModule': {'nctId': 'NCT04292951', 'briefTitle': 'Early Goal Directed Therapy in Cardiac Surgery', 'organization': {'class': 'OTHER', 'fullName': 'Khon Kaen University'}, 'officialTitle': 'Early Goal Directed Therapy vs Standard Protocol for Hemodynamic Management in Patients Undergoing Cardiac Surgery: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'HE611321'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'GDT group', 'description': 'Intraoperative fluid and inotropic/vasoactive drugs management based on information from FloTrac/EV1000', 'interventionNames': ['Procedure: Fluid and inotropic/vasoactive management protocol']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Control group', 'description': 'Intraoperative fluid and inotropic/vasoactive drugs management based on CVP, blood pressure, heart rate, and clinical signs at the discretion of attending anesthesiologists', 'interventionNames': ['Procedure: Fluid and inotropic/vasoactive management protocol']}], 'interventions': [{'name': 'Fluid and inotropic/vasoactive management protocol', 'type': 'PROCEDURE', 'description': 'GDT protocol: keep SVV 10-13% and give fluid when SVV \\> 13%, give inotropic to maintain CI 2.5-4 L/min/m2, give vasoactive drugs to maintain SVRI 1,900-2,400 dynes-sec/cm-5/m2 Control protocol: keep CVP 8-12 mmHG and give fluid when CVP \\< 8 mmHg, give inotropic/vasoactive to maintain normal blood pressure and heart rate', 'armGroupLabels': ['Control group', 'GDT group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '40002', 'city': 'Khon Kaen', 'country': 'Thailand', 'facility': 'Faculty of Medicine, Khon Kaen University', 'geoPoint': {'lat': 16.44671, 'lon': 102.833}}], 'overallOfficials': [{'name': 'Thepakorn Sathitkarnmanee, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Faculty of Medicine, Khon Kaen University, Khon Kaen, Thailand'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Khon Kaen University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate professor', 'investigatorFullName': 'Thepakorn Sathitkarnmanee', 'investigatorAffiliation': 'Khon Kaen University'}}}}