Early Goal Directed Therapy in Cardiac Surgery

Study Overview
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Brief Summary
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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
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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.

Official Title
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Early Goal Directed Therapy vs Standard Protocol for Hemodynamic Management in Patients Undergoing Cardiac Surgery: A Randomized Controlled Trial

Conditions
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Postoperative Outcome, ICU Stay

Intervention / Treatment
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* Procedure: Fluid and inotropic/vasoactive management protocol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GDT group<br>Intraoperative fluid and inotropic/vasoactive drugs management based on information from FloTrac/EV1000 | Procedure: Fluid and inotropic/vasoactive management protocol<br>* 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<br>|
| Active Comparator: Control group<br>Intraoperative fluid and inotropic/vasoactive drugs management based on CVP, blood pressure, heart rate, and clinical signs at the discretion of attending anesthesiologists | Procedure: Fluid and inotropic/vasoactive management protocol<br>* 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<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of inotropic/vaso active drugs requirement | number of inotropic/vasoactive drugs required to maintain normal blood pressure and heart rate | up to Day 1 postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ICU stay | number of hours admitted in ICU | up to day 10 postoperatively | 
| Lactate level | serum lactate level | up to Day 1 postoperatively | 
| Creatinine level | serum creatinine level | up to day 10 postoperatively | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Postoperative outcome, Goal directed therapy, Arterial pressure derived cardiac output