Ignite Creation Date:
2025-12-24 @ 1:18 PM
Ignite Modification Date:
2025-12-31 @ 3:23 PM
Study NCT ID:
NCT05826795
Status:
UNKNOWN
Last Update Posted:
2023-04-24
First Post:
2023-04-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cost-effectiveness of EGDT Using FloTrac/EV1000
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003324', 'term': 'Coronary Artery Disease'}], 'ancestors': [{'id': 'D003327', 'term': 'Coronary Disease'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D001161', 'term': 'Arteriosclerosis'}, {'id': 'D001157', 'term': 'Arterial Occlusive Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000074388', 'term': 'Early Goal-Directed Therapy'}], 'ancestors': [{'id': 'D003422', 'term': 'Critical Care'}, {'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2023-05-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-04-12', 'studyFirstSubmitDate': '2023-04-12', 'studyFirstSubmitQcDate': '2023-04-12', 'lastUpdatePostDateStruct': {'date': '2023-04-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-04-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-05-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'ICU stay', 'timeFrame': '1 month', 'description': 'The duration the patient was admitted in CVT ICU.'}], 'secondaryOutcomes': [{'measure': 'Average daily ICU cost', 'timeFrame': '1 month', 'description': 'The average cost per day of CVT ICU'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Cost-effectiveness', 'Early goal-directed therapy', 'FloTrac/EV1000', 'ICU stay'], 'conditions': ['Coronary Artery Disease']}, 'referencesModule': {'references': [{'pmid': '34234581', 'type': 'RESULT', 'citation': 'Tribuddharat S, Sathitkarnmanee T, Ngamsangsirisup K, Nongnuang K. Efficacy of Intraoperative Hemodynamic Optimization Using FloTrac/EV1000 Platform for Early Goal-Directed Therapy to Improve Postoperative Outcomes in Patients Undergoing Coronary Artery Bypass Graft with Cardiopulmonary Bypass: A Randomized Controlled Trial. Med Devices (Auckl). 2021 Jun 28;14:201-209. doi: 10.2147/MDER.S316033. eCollection 2021.'}, {'pmid': '35989328', 'type': 'RESULT', '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.'}, {'pmid': '23447502', 'type': 'RESULT', 'citation': 'Aya HD, Cecconi M, Hamilton M, Rhodes A. Goal-directed therapy in cardiac surgery: a systematic review and meta-analysis. Br J Anaesth. 2013 Apr;110(4):510-7. doi: 10.1093/bja/aet020. Epub 2013 Feb 27.'}, {'pmid': '29369117', 'type': 'RESULT', 'citation': 'Chong MA, Wang Y, Berbenetz NM, McConachie I. Does goal-directed haemodynamic and fluid therapy improve peri-operative outcomes?: A systematic review and meta-analysis. Eur J Anaesthesiol. 2018 Jul;35(7):469-483. doi: 10.1097/EJA.0000000000000778.'}, {'pmid': '24086168', 'type': 'RESULT', 'citation': 'Gutierrez MC, Moore PG, Liu H. Goal-directed therapy in intraoperative fluid and hemodynamic management. J Biomed Res. 2013 Sep;27(5):357-65. doi: 10.7555/JBR.27.20120128. Epub 2013 Mar 10.'}, {'pmid': '1594234', 'type': 'RESULT', 'citation': 'Neumann K, Muhr G, Breitfuss H. [Primary humerus head replacement in dislocated proximal humeral fracture. Indications, technique, results]. Orthopade. 1992 Apr;21(2):140-7. German.'}, {'pmid': '25986476', 'type': 'RESULT', 'citation': 'Lefrant JY, Garrigues B, Pribil C, Bardoulat I, Courtial F, Maurel F, Bazin JE; CRREA Study Group; AzuRea Group. The daily cost of ICU patients: A micro-costing study in 23 French Intensive Care Units. Anaesth Crit Care Pain Med. 2015 Jun;34(3):151-7. doi: 10.1016/j.accpm.2014.09.004. Epub 2015 May 16.'}]}, 'descriptionModule': {'briefSummary': 'Coronary artery bypass graft (CABG) with cardiopulmonary bypass (CPB) is a high-risk surgery with significant morbidity that results in a prolonged stay in the intensive care unit (ICU) at an increased cost. Early goal-directed therapy (EGDT) using the FloTrac/EV1000 platform improved outcomes in these patients with shorter ICU stay but with extra cost for a FloTrac transducer. The objective of this study is to assess the cost-effectiveness of implementing the FloTrac/EV1000 in these patients.', 'detailedDescription': 'EGDT using FloTrac/EV1000 platform has been reported to improve outcomes in patients undergoing CABG with CPB resulting in a reduction in cardiovascular and thoracic ICU (CVT ICU) and hospital stay. However, the use of the FloTrac sensor has an extra cost that impedes its implementation. There is still no study that assesses the cost-effectiveness of implementing FloTrac in cardiac surgery.\n\nThe objective of our study is to evaluate the cost-effectiveness of applying EGDT using the FloTrac/EV1000 platform in patients undergoing CABG with CPB.\n\nThere are 2 steps in this study:\n\n1. Assessing the efficacy of the FloTrac/EV1000 platform\n2. Assessing the daily CVT ICU cost\n\nAssessing the efficacy of the FloTrac/EV1000 platform\n\nWe compare the efficacy of the FloTrac/EV1000 versus standard practice. The sample size of 30 patients per group was calculated based on data from a previous study, an α value of 0.05, a β value of 0.2, and a 30% decrease in ICU stay. Sixty patients undergoing CABG with CPB at Srinagarind Hospital or Queen Sirikit Heart Center of the Northeast between July 2018 and June 2020 will be recruited. They will be divided into 2 groups: EV1000 and Control. The intraoperative hemodynamic optimization in the EV1000 was managed using goal-directed therapy via the FloTrac/EV1000 platform and the Control was managed using a standard protocol as described in the study of Tribuddharat et al. The extracted data for comparison were: demographic and clinical data, CVT ICU stay, ventilator time in CVT ICU, postoperative complications, and hospital stay. The ICU stay of both groups will be compared.\n\nAssessing the daily CVT ICU cost\n\nWe will evaluate the ICU cost of the CVT ICU of Srinagarind Hospital by recruiting another group of patients who were admitted to the CVT ICU during October 2021 to identify the average daily cost. The cost of a FloTrac sensor and the ICU cost saved will be compared.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Adult patients undergoing elective CABG with CPB at Srinagarind Hospital or Queen Sirikit Heart Center of the Northeast between July 2018 and June 2020.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult patients who underwent CABG with CPB.\n\nExclusion Criteria:\n\n* Patients who required an intra-aortic balloon pump or extracorporeal membrane oxygenator.'}, 'identificationModule': {'nctId': 'NCT05826795', 'briefTitle': 'Cost-effectiveness of EGDT Using FloTrac/EV1000', 'organization': {'class': 'OTHER', 'fullName': 'Khon Kaen University'}, 'officialTitle': 'Cost-effectiveness of Applying Early Goal-directed Therapy Using FloTrac/EV1000 Platform in Patients Undergoing Coronary Artery Bypass Graft With Cardiopulmonary Bypass', 'orgStudyIdInfo': {'id': 'HE631648'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Control', 'description': 'During the intraoperative period, both before and after CPB, the Control group received fluid, inotropic, and/or vasoactive drugs at the discretion of the attending anesthesiologists to achieve the following goals: MAP 65-90 mmHg; CVP 8-12 mmHg; urine output ≥ 0.5 mL·kg-1·h-1; SpO2 \\> 95%; and hematocrit 26-30%. Arterial blood gas (ABG) and electrolytes were monitored and corrected hourly.'}, {'label': 'EV1000', 'description': 'The patients were managed to achieve similar goals: MAP 65-90 mmHg; urine output ≥ 0.5 mL·kg-1·h-1; SpO2 \\> 95%; and hematocrit 26-30%, using information from the FloTrac/EV1000. The EGDT group received: fluid to maintain a SVV \\< 13%; inotropic drugs to achieve a SVI of 33-65 mL·beat-1·m-2 and CI of 2.2-4.0 L·min-1·m-2; and/or vasoactive drugs to achieve a SVRI of 1600-2500 dynes·s·cm-5·m-2. ABG and electrolytes were monitored and corrected in the same manner.', 'interventionNames': ['Procedure: Early goal-directed therapy (EGDT)']}], 'interventions': [{'name': 'Early goal-directed therapy (EGDT)', 'type': 'PROCEDURE', 'otherNames': ['FloTrac/EV1000 platform'], 'description': 'The principle of hemodynamic optimization to achieve the defined goals.', 'armGroupLabels': ['EV1000']}]}, 'contactsLocationsModule': {'locations': [{'zip': '40002', 'city': 'Khon Kaen', 'status': 'RECRUITING', 'country': 'Thailand', 'contacts': [{'name': 'Thepakorn Sathitkarnmanee, MD', 'role': 'CONTACT', 'email': 'thepakorns@gmail.com', 'phone': '+66819547622'}, {'name': 'Sirirat Tribuddharat, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Faculty of Medicine, Khon Kaen University', 'geoPoint': {'lat': 16.44671, 'lon': 102.833}}, {'zip': '40002', 'city': 'Khon Kaen', 'status': 'RECRUITING', 'country': 'Thailand', 'contacts': [{'name': 'Thepakorn Sathitkarnmanee, MD', 'role': 'CONTACT', 'email': 'thepakorns@gmail.com', 'phone': '66-81-9547622'}, {'name': 'Thepakorn Sathitkarnmanee, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Thepakorn Sathitkarnmanee', 'geoPoint': {'lat': 16.44671, 'lon': 102.833}}], 'centralContacts': [{'name': 'Thepakorn Sathitkarnmanee, MD', 'role': 'CONTACT', 'email': 'thepakorns@gmail.com', 'phone': '66-81-9547622'}, {'name': 'Sirirat Tribuddharat, MD, PhD', 'role': 'CONTACT', 'email': 'sirirat.tribuddharat@gmail.com', 'phone': '66-81-6205920'}], 'overallOfficials': [{'name': 'Sirirat Tribuddharat, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Faculty of Medicine, Khon Kaen University'}]}, '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'}}}}