Postoperative OutcomeNCT04292951
Early Goal Directed Therapy in Cardiac Surgery
A study testing Fluid and inotropic/vasoactive management protocol in people with Postoperative Outcome and ICU Stay, run by Khon Kaen University at 1 site in Thailand.
Trial summary
Early goal directed therapy (EGDT) based on information from arterial waveform derived cardiac output (APCO) FloTrac/EV1000 system has been proved to improve postoperative outcomes in patients undergoing major surgery. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Postoperative Outcome, ICU Stay
- What is being tested?
- Fluid and inotropic/vasoactive management protocol
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteThailand
- Study dates
- 1 Jan 2020to 1 Jul 2020
- Phase
- Interventional
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18-80 years old
- Patient has ischemic or valvular heart disease
- Scheduled for elective cardiac surgery
- New York Heart Association (NYHA) or American society of Anesthesiology (ASA) classification I-III
- Body mass index (BMI) 18-24 kg/m2
- Provided informed consent before surgery
Who cannot join
- Scheduled for emergency or redo surgery
- Difficulty (or contraindication to) placing a central venous catheter
- Inability to cooperate (e.g. mental disorder, disturbance of consciousness, mental retardation)
- Presence of blood-borne infectious disease (e.g. syphilis, acquired immunodeficiency
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Early Goal Directed Therapy vs Standard Protocol for Hemodynamic Management in Patients Undergoing Cardiac Surgery: A Randomized Controlled Trial
Early goal directed therapy (EGDT) based on information from arterial waveform derived cardiac output (APCO) FloTrac/EV1000 system has been proved to improve postoperative outcomes in patients undergoing major surgery. This system, however, has the limitation to be applied in open-chest surgery, especially cardiac surgery. The efficiency of FloTrac/EV1000 system to improve postoperative outcomes in cardiac surgery is still inconclusive.
Hypothesis: Intraoperative management in patients undergoing cardiac surgery guided by FloTrac/EV1000 system, compared with conventional protocol, results in better clinical outcomes.
Read more
Primary outcomes: Immediate postoperative inotropic/vasoactive drugs requirement.
Methods: Adult patients undergoing cardiac surgery will be randomized into 2 groups: EGDT group managed by FloTrac/EV1000 system and Control group managed by conventional protocol.
Outcome analyses: Compare the number of inotropic/vasoactive drugs requirement at the end of surgery, as well as intensive care unit (ICU) stay between both groups.
Read the detailed description
Objective: To compare postoperative clinical outcome in adult patients undergoing cardiac surgery.
Primary outcome: Postoperative inotropic/vasoactive drugs reqirement.
Secondary outcome: ICU stay.
Methods: Eligible patients will be randomized to 2 groups. Both groups will be managed intraoperatively in the same way, except fluid and inotropic/vasoactive drugs management protocol. EGDT group will be managed according to information derived from FloTrac/EV1000 system, i.e., control stroke volume variation (SVV) 10-13% and give fluid when SVV > 13%, give inotropic to maintain cardiac index (CI) 2.5-4 L/min/m2, and give vasoactive drugs to maintain systemic vascular resistance index (SVRI) of 1,900-2,400 dynes-sec/cm-5/m2 . Control group will be managed using central venous pressure (CVP) protocol, i.e., control CVP 8-12 mmHg and give fluid when CVP < 8 mmHg, give inotropic/vasoactive drugs according to blood pressure and heart rate as well as clinical signs at the discretion of attending anesthesiologists.
Outcome analyses: Postoperative number of inotropic/vasoactive drugs requirement as well as ICU stay of both groups will be compared using unpaired Student-t test or Mann-Whitney U test.
- Conditions
- Postoperative Outcome, ICU Stay
- Being tested
- Fluid and inotropic/vasoactive management protocol
- Keywords
- Postoperative outcome, Goal directed therapy, Arterial pressure derived cardiac output
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluid and inotropic/vasoactive management protocolProcedure or surgery
GDT protocol: keep SVV 10-13% and give fluid when SVV > 13%, give inotropic to maintain CI 2.5-4 L/min/m2, give vasoactive drugs to maintain SVRI 1,900-2,400 dynes-sec/cm-5/m2 Control protocol: keep CVP 8-12 mmHG and give fluid when CVP < 8 mmHg, give inotropic/vasoactive to maintain normal blood pressure and heart rate
| Study group | Role | What they receive |
|---|---|---|
| GDT group | Experimental | Intraoperative fluid and inotropic/vasoactive drugs management based on information from FloTrac/EV1000 Receives: Procedure: Fluid and inotropic/vasoactive management protocol |
| Control group | Active comparator | Intraoperative fluid and inotropic/vasoactive drugs management based on CVP, blood pressure, heart rate, and clinical signs at the discretion of attending anesthesiologists Receives: Procedure: Fluid and inotropic/vasoactive management protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of inotropic/vaso active drugs requirement
number of inotropic/vasoactive drugs required to maintain normal blood pressure and heart rate
Measured: up to Day 1 postoperatively
Secondary outcomes (3)
ICU stay
number of hours admitted in ICU
Measured: up to day 10 postoperatively
Lactate level
serum lactate level
Measured: up to Day 1 postoperatively
Creatinine level
serum creatinine level
Measured: up to day 10 postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2020
- Study start1 Jan 2020
- Primary completion1 Jun 2020
- Study completion1 Jul 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Postoperative OutcomeStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Group GDT: fluid and inotropic/vasoactive drugs management guided by FloTrac/EV1000 Group Control: fluid and inotropic/vasoactive drugs management guided by central venous pressure (CVP), blood pressure, heart rate, and clinical signs
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Khon Kaen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Thepakorn Sathitkarnmanee, Khon Kaen University
- Investigators
- Thepakorn Sathitkarnmanee, MD, Study chair, Faculty of Medicine, Khon Kaen University, Khon Kaen, Thailand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04292951
- Sponsor's protocol ID
- HE611321
- Status last verified
- Aug 2020
- First submitted
- 1 Mar 2020
- Last updated
- 2 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bednarczyk JM, Fridfinnson JA, Kumar A, Blanchard L, Rabbani R, Bell D, Funk D, Turgeon AF, Abou-Setta AM, Zarychanski R. Incorporating Dynamic Assessment of Fluid Responsiveness Into Goal-Directed Therapy: A Systematic Review and Meta-Analysis. Crit Care Med. 2017 Sep;45(9):1538-1545. doi: 10.1097/CCM.0000000000002554.
PubMed 28817481Kapoor PM, Kakani M, Chowdhury U, Choudhury M, Lakshmy, Kiran U. Early goal-directed therapy in moderate to high-risk cardiac surgery patients. Ann Card Anaesth. 2008 Jan-Jun;11(1):27-34. doi: 10.4103/0971-9784.38446.
PubMed 18182756Kusaka Y, Ohchi F, Minami T. Evaluation of the Fourth-Generation FloTrac/Vigileo System in Comparison With the Intermittent Bolus Thermodilution Method in Patients Undergoing Cardiac Surgery. J Cardiothorac Vasc Anesth. 2019 Apr;33(4):953-960. doi: 10.1053/j.jvca.2018.06.017. Epub 2018 Jun 28.
PubMed 30077561Lopes MR, Oliveira MA, Pereira VO, Lemos IP, Auler JO Jr, Michard F. Goal-directed fluid management based on pulse pressure variation monitoring during high-risk surgery: a pilot randomized controlled trial. Crit Care. 2007;11(5):R100. doi: 10.1186/cc6117.
PubMed 17822565Tribuddharat S, Ratanasuwan P, Sathitkarnmanee T, Chaimala N, Polsena L, Mantruad P. Impact of FloTrac/EV1000-guided intraoperative hemodynamic optimization on postoperative outcomes in cardiac valve surgery: a randomized controlled trial. Sci Rep. 2026 Mar 29;16(1):10698. doi: 10.1038/s41598-026-46157-x.
PubMed 41905981Tribuddharat 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 35989328
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Goal Directed Therapy vs Standard Protocol for Hemodynamic Management in Patients Undergoing Cardiac Surgery: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04292951
- Acronym / sponsor ID
- HE611321
- Conditions
- Postoperative Outcome, ICU Stay
- Keywords
- Postoperative outcome, Goal directed therapy, Arterial pressure derived cardiac output
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Khon Kaen UniversityUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 1 Jun 2020 (actual)
- Study completion
- 1 Jul 2020 (actual)
- First posted
- 3 Mar 2020 (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.
Early goal directed therapy (EGDT) based on information from arterial waveform derived cardiac output (APCO) FloTrac/EV1000 system has been proved to improve postoperative outcomes in patients undergoing major surgery. This system, however, has the limitation to be applied in open-chest surgery, especially cardiac surgery. The efficiency of FloTrac/EV1000 system to improve postoperative outcomes in cardiac surgery is still inconclusive.
Hypothesis: Intraoperative management in patients undergoing cardiac surgery guided by FloTrac/EV1000 system, compared with conventional protocol, results in better clinical outcomes.
Primary outcomes: Immediate postoperative inotropic/vasoactive drugs requirement.
Methods: Adult patients undergoing cardiac surgery will be randomized into 2 groups: EGDT group managed by FloTrac/EV1000 system and Control group managed by conventional protocol.
Outcome analyses: Compare the number of inotropic/vasoactive drugs requirement at the end of surgery, as well as intensive care unit (ICU) stay between both groups.
Detailed description
Objective: To compare postoperative clinical outcome in adult patients undergoing cardiac surgery.
Primary outcome: Postoperative inotropic/vasoactive drugs reqirement.
Secondary outcome: ICU stay.
Methods: Eligible patients will be randomized to 2 groups. Both groups will be managed intraoperatively in the same way, except fluid and inotropic/vasoactive drugs management protocol. EGDT group will be managed according to information derived from FloTrac/EV1000 system, i.e., control stroke volume variation (SVV) 10-13% and give fluid when SVV > 13%, give inotropic to maintain cardiac index (CI) 2.5-4 L/min/m2, and give vasoactive drugs to maintain systemic vascular resistance index (SVRI) of 1,900-2,400 dynes-sec/cm-5/m2 . Control group will be managed using central venous pressure (CVP) protocol, i.e., control CVP 8-12 mmHg and give fluid when CVP < 8 mmHg, give inotropic/vasoactive drugs according to blood pressure and heart rate as well as clinical signs at the discretion of attending anesthesiologists.
Outcome analyses: Postoperative number of inotropic/vasoactive drugs requirement as well as ICU stay of both groups will be compared using unpaired Student-t test or Mann-Whitney U test.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Group GDT: fluid and inotropic/vasoactive drugs management guided by FloTrac/EV1000 Group Control: fluid and inotropic/vasoactive drugs management guided by central venous pressure (CVP), blood pressure, heart rate, and clinical signs
| Arm | Type | Receives |
|---|---|---|
| GDT group | Experimental | Procedure: Fluid and inotropic/vasoactive management protocolIntraoperative fluid and inotropic/vasoactive drugs management based on information from FloTrac/EV1000 |
| Control group | Active comparator | Procedure: Fluid and inotropic/vasoactive management protocolIntraoperative fluid and inotropic/vasoactive drugs management based on CVP, blood pressure, heart rate, and clinical signs at the discretion of attending anesthesiologists |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 18-80 years old
- Patient has ischemic or valvular heart disease
- Scheduled for elective cardiac surgery
- New York Heart Association (NYHA) or American society of Anesthesiology (ASA) classification I-III
- Body mass index (BMI) 18-24 kg/m2
Key exclusion criteria (4 listed)
- Scheduled for emergency or redo surgery
- Difficulty (or contraindication to) placing a central venous catheter
- Inability to cooperate (e.g. mental disorder, disturbance of consciousness, mental retardation)
- Presence of blood-borne infectious disease (e.g. syphilis, acquired immunodeficiency
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 |
|---|---|---|
| Fluid and inotropic/vasoactive management protocolGDT protocol: keep SVV 10-13% and give fluid when SVV > 13%, give inotropic to maintain CI 2.5-4 L/min/m2, give vasoactive drugs to maintain SVRI 1,900-2,400 dynes-sec/cm-5/m2 Control protocol: keep CVP 8-12 mmHG and give fluid when CVP < 8 mmHg, give inotropic/vasoactive to maintain normal blood pressure and heart rate | Procedure or surgery | Control group, GDT group |
Primary outcome
Number of inotropic/vaso active drugs requirement
Time frame: up to Day 1 postoperatively
number of inotropic/vasoactive drugs required to maintain normal blood pressure and heart rate
3 secondary outcomes
ICU stay
Time frame: up to day 10 postoperatively
Lactate level
Time frame: up to Day 1 postoperatively
Creatinine level
Time frame: up to day 10 postoperatively
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2020.
- Results publication: PubMed 28817481Bednarczyk JM, Fridfinnson JA, Kumar A, Blanchard L, Rabbani R, Bell D, Funk D, Turgeon AF, Abou-Setta AM, Zarychanski R. Incorporating Dynamic Assessment of Fluid Responsiveness Into Goal-Directed Therapy: A Systematic Review and Meta-Analysis. Crit Care Med. 2017 Sep;45(9):1538-1545. doi: 10.1097/CCM.0000000000002554.
- Results publication: PubMed 18182756Kapoor PM, Kakani M, Chowdhury U, Choudhury M, Lakshmy, Kiran U. Early goal-directed therapy in moderate to high-risk cardiac surgery patients. Ann Card Anaesth. 2008 Jan-Jun;11(1):27-34. doi: 10.4103/0971-9784.38446.
- Results publication: PubMed 30077561Kusaka Y, Ohchi F, Minami T. Evaluation of the Fourth-Generation FloTrac/Vigileo System in Comparison With the Intermittent Bolus Thermodilution Method in Patients Undergoing Cardiac Surgery. J Cardiothorac Vasc Anesth. 2019 Apr;33(4):953-960. doi: 10.1053/j.jvca.2018.06.017. Epub 2018 Jun 28.
- Results publication: PubMed 17822565Lopes MR, Oliveira MA, Pereira VO, Lemos IP, Auler JO Jr, Michard F. Goal-directed fluid management based on pulse pressure variation monitoring during high-risk surgery: a pilot randomized controlled trial. Crit Care. 2007;11(5):R100. doi: 10.1186/cc6117.
- Derived from this study: PubMed 41905981Tribuddharat S, Ratanasuwan P, Sathitkarnmanee T, Chaimala N, Polsena L, Mantruad P. Impact of FloTrac/EV1000-guided intraoperative hemodynamic optimization on postoperative outcomes in cardiac valve surgery: a randomized controlled trial. Sci Rep. 2026 Mar 29;16(1):10698. doi: 10.1038/s41598-026-46157-x.
- Derived from this study: 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.
- Individual participant dataSharing planned: No
Related trials for Postoperative Outcome
RecruitingObservational study
Preoperative Anxiety and One-year Patient-reported Outcomes in Orthopedic Surgery Patients Receiving Enhanced Recovery After Surgery or Conventional Care
Preoperative Anxiety, Orthopedic Surgery
Enrolling by invitation
Early Outcome of Simultaneous Bilateral Total Knee Replacement With and Without Tourniquet
Arthroplasty, Replacement, Knee, Blood Loss, Surgical
Recruiting
PROtective Ventilation With FLOW-Controlled Ventilation
Postoperative Pulmonary Complications (PPCs), Feasibility Studies
Recruiting
A Clinical Study to Compare Functional Outcomes After Surgery Using a Transverse or Longitudinal Surgical Incision in the Skin.
Functional Disturbance as Result
Not yet recruiting
Postoperative Pulmonary Function Assessment Based on Deep Learning Study
Lung Cancer (NSCLC)
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.
Thepakorn Sathitkarnmanee, MD study chair
Faculty of Medicine, Khon Kaen University, Khon Kaen, Thailand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fluid and inotropic/vasoactive management protocol in people with Postoperative Outcome and ICU Stay, run by Khon Kaen University at 1 site 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 6 inclusion and 4 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: finished, as of the sponsor's last update on 2 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of inotropic/vaso active drugs requirement (time frame: up to Day 1 postoperatively). 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 NCT04292951, which also lists 6 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 2 Sep 2020.