Coronary Artery DiseaseNCT05826795
Cost-effectiveness of EGDT Using FloTrac/EV1000
An observational study of Coronary Artery Disease, run by Khon Kaen University at 2 sites in Thailand.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Coronary Artery Disease
- What is being tested?
- Early goal-directed therapy (EGDT)
- Type of treatment
- Surgery or procedure
- How many people
- 60 participants
- Where
- 2 sitesThailand
- Study dates
- 1 Apr 2023to 10 May 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Adult patients who underwent CABG with CPB.
Who cannot join
- Patients who required an intra-aortic balloon pump or extracorporeal membrane oxygenator.
Trial locations and contacts
2 sites in 1 country.
Thailand2 sites, 2 recruiting
- Recruiting
Faculty of Medicine, Khon Kaen University
Khon Kaen, 40002
Thepakorn Sathitkarnmanee, MD, +66819547622, thepakorns@gmail.com
Sirirat Tribuddharat, MD, PhD
- Recruiting
Thepakorn Sathitkarnmanee
Khon Kaen, 40002
Thepakorn Sathitkarnmanee, MD, 66-81-9547622, thepakorns@gmail.com
Thepakorn Sathitkarnmanee, MD
About this study
Official title: Cost-effectiveness of Applying Early Goal-directed Therapy Using FloTrac/EV1000 Platform in Patients Undergoing Coronary Artery Bypass Graft With Cardiopulmonary Bypass
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.
Read the 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:
- Assessing the efficacy of the FloTrac/EV1000 platform
- 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
- Coronary Artery Disease
- Being tested
- Early goal-directed therapy (EGDT)
- Keywords
- Cost-effectiveness, Early goal-directed therapy, FloTrac/EV1000, ICU stay
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early goal-directed therapy (EGDT)Procedure or surgery
Also called FloTrac/EV1000 platform
The principle of hemodynamic optimization to achieve the defined goals.
| Study group | Role | What they receive |
|---|---|---|
| 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. | |
| 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. Receives: Procedure: Early goal-directed therapy (EGDT) |
What is being measured
The primary outcome is the main question the study is designed to answer.
ICU stay
The duration the patient was admitted in CVT ICU.
Measured: 1 month
Secondary outcomes (1)
Average daily ICU cost
The average cost per day of CVT ICU
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Apr 2023
- Study start1 Apr 2023
- Primary completion1 May 2023 (estimated)
- Study completion10 May 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Khon Kaen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thepakorn Sathitkarnmanee, Khon Kaen University
- Investigators
- Sirirat Tribuddharat, MD, PhD, Principal investigator, Khon Kaen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05826795
- Sponsor's protocol ID
- HE631648
- Status last verified
- Apr 2023
- First submitted
- 12 Apr 2023
- Last updated
- 24 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 34234581Tribuddharat 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.
PubMed 35989328Aya 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.
PubMed 23447502Chong 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.
PubMed 29369117Gutierrez 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.
PubMed 24086168Neumann 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.
PubMed 1594234Lefrant 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.
PubMed 25986476
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cost-effectiveness of Applying Early Goal-directed Therapy Using FloTrac/EV1000 Platform in Patients Undergoing Coronary Artery Bypass Graft With Cardiopulmonary Bypass
- ClinicalTrials.gov ID
- NCT05826795
- Acronym / sponsor ID
- HE631648
- Conditions
- Coronary Artery Disease
- Keywords
- Cost-effectiveness, Early goal-directed therapy, FloTrac/EV1000, ICU stay
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Khon Kaen UniversityUniversity, hospital or other
- Study start
- 1 Apr 2023 (actual)
- Primary completion
- 1 May 2023 (estimated)
- Study completion
- 10 May 2023 (estimated)
- First posted
- 24 Apr 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Assessing the efficacy of the FloTrac/EV1000 platform
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
| EV1000 | – | Procedure: Early goal-directed therapy (EGDT)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. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Adult patients who underwent CABG with CPB.
Key exclusion criteria (1 listed)
- Patients who required an intra-aortic balloon pump or extracorporeal membrane oxygenator.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Early goal-directed therapy (EGDT)Also: FloTrac/EV1000 platformThe principle of hemodynamic optimization to achieve the defined goals. | Procedure or surgery | EV1000 |
Primary outcome
ICU stay
Time frame: 1 month
The duration the patient was admitted in CVT ICU.
1 secondary outcome
Average daily ICU cost
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2023.
- Results publication: PubMed 34234581Tribuddharat 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.
- Results publication: PubMed 35989328Tribuddharat 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.
- Results publication: PubMed 23447502Aya 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.
- Results publication: PubMed 29369117Chong 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.
- Results publication: PubMed 24086168Gutierrez 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.
- Results publication: PubMed 1594234Neumann 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.
- Results publication: PubMed 25986476Lefrant 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sirirat Tribuddharat, MD, PhD principal investigator
Khon Kaen University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Artery Disease, run by Khon Kaen University at 2 sites in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Thepakorn Sathitkarnmanee, MD (66-81-9547622, thepakorns@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
ICU stay (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05826795, which also lists 7 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2023.