Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
60 participants
OBSERVATIONAL
2023-04-01
2023-05-10
Brief Summary
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Detailed Description
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The objective of our study is to evaluate the cost-effectiveness of applying EGDT using the FloTrac/EV1000 platform in patients undergoing CABG with CPB.
There are 2 steps in this study:
1. Assessing the efficacy of the FloTrac/EV1000 platform
2. Assessing the daily CVT ICU cost
Assessing the efficacy of the FloTrac/EV1000 platform
We 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.
Assessing the daily CVT ICU cost
We 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.
Conditions
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Study Design
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COHORT
RETROSPECTIVE
Study Groups
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Control
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.
No interventions assigned to this group
EV1000
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.
Early goal-directed therapy (EGDT)
The principle of hemodynamic optimization to achieve the defined goals.
Interventions
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Early goal-directed therapy (EGDT)
The principle of hemodynamic optimization to achieve the defined goals.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
85 Years
ALL
No
Sponsors
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Khon Kaen University
OTHER
Responsible Party
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Thepakorn Sathitkarnmanee
Associate professor
Principal Investigators
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Sirirat Tribuddharat, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Faculty of Medicine, Khon Kaen University
Locations
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Faculty of Medicine, Khon Kaen University
Khon Kaen, , Thailand
Thepakorn Sathitkarnmanee
Khon Kaen, , Thailand
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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HE631648
Identifier Type: -
Identifier Source: org_study_id
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