Early Goal Directed Therapy in Cardiac Surgery
Condition: Postoperative Outcome; ICU Stay
Study type: Interventional

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. 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.
    

Intervention name(s): Fluid and inotropic/vasoactive management protocol
Intervention type(s): Procedure
Intervention description(s): 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
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention 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 (Participant, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Postoperative outcome; Goal directed therapy; Arterial pressure derived cardiac output