Clinical trial NCT05826795: Cost-effectiveness of EGDT Using FloTrac/EV1000
Official title: Cost-effectiveness of Applying Early Goal-directed Therapy Using FloTrac/EV1000 Platform in Patients Undergoing Coronary Artery Bypass Graft With Cardiopulmonary Bypass
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Coronary Artery Disease
Keywords: Cost-effectiveness
Early goal-directed therapy
FloTrac/EV1000
ICU stay
Lead sponsor: Khon Kaen University
Sponsor class: OTHER
First posted: 2023-04-24
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Adult patients undergoing elective CABG with CPB at Srinagarind Hospital or Queen Sirikit Heart Center of the Northeast between July 2018 and June 2020.

Brief summary: 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.

Detailed description: 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.

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.

Eligibility criteria: Inclusion Criteria:

* Adult patients who underwent CABG with CPB.

Exclusion Criteria:

* Patients who required an intra-aortic balloon pump or extracorporeal membrane oxygenator.

Primary outcomes:
measure: ICU stay
timeFrame: 1 month
Secondary outcomes:
measure: Average daily ICU cost
timeFrame: 1 month
Other outcomes:
Locations:
city: Khon Kaen
country: Thailand
facility: Faculty of Medicine, Khon Kaen University
city: Khon Kaen
country: Thailand
facility: Thepakorn Sathitkarnmanee
Study officials:
affiliation: Faculty of Medicine, Khon Kaen University
name: Sirirat Tribuddharat, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.
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.
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.