Early Goal Directed Therapy vs Standard Protocol for Hemodynamic Management in Patients Undergoing Cardiac Surgery: A Randomized Controlled Trial
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Postoperative Outcome
- Sponsor
- Khon Kaen University
- Enrollment
- 80
- Locations
- 1
- Primary Endpoint
- Number of inotropic/vaso active drugs requirement
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief 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.
Investigators
Thepakorn Sathitkarnmanee
Associate professor
Khon Kaen University
Eligibility Criteria
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
Outcomes
Primary Outcomes
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
Secondary Outcomes
- ICU stay(up to day 10 postoperatively)
- Lactate level(up to Day 1 postoperatively)
- Creatinine level(up to day 10 postoperatively)