Cost-effectiveness of EGDT Using FloTrac/EV1000

April 12, 2023 updated by: Thepakorn Sathitkarnmanee, Khon Kaen University

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Anticipated)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Thailand
      • Khon Kaen, Thailand, 40002
        • Recruiting
        • Faculty Of Medicine, Khon Kaen University
        • Contact:
        • Principal Investigator:
          • Sirirat Tribuddharat, MD, PhD
      • Khon Kaen, Thailand, 40002
        • Recruiting
        • Thepakorn Sathitkarnmanee
        • Contact:
        • Principal Investigator:
          • Thepakorn Sathitkarnmanee, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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.

Description

Inclusion Criteria:

  • Adult patients who underwent CABG with CPB.

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.
Procedure: Early goal-directed therapy (EGDT)
The principle of hemodynamic optimization to achieve the defined goals.
Other Names:
  • FloTrac/EV1000 platform

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ICU stay
Time Frame: 1 month
The duration the patient was admitted in CVT ICU.
1 month

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Average daily ICU cost
Time Frame: 1 month
The average cost per day of CVT ICU
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Khon Kaen University

Investigators

  • Principal Investigator: Sirirat Tribuddharat, MD, PhD, Faculty Of Medicine, Khon Kaen University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2023

Primary Completion (Anticipated)

May 1, 2023

Study Completion (Anticipated)

May 10, 2023

Study Registration Dates

First Submitted

April 12, 2023

First Submitted That Met QC Criteria

April 12, 2023

First Posted (Actual)

April 24, 2023

Study Record Updates

Last Update Posted (Actual)

April 24, 2023

Last Update Submitted That Met QC Criteria

April 12, 2023

Last Verified

April 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HE631648

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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