ICU Stay, Postoperative Outcome
Conditions
Keywords
Postoperative outcome, Goal directed therapy, Arterial pressure derived cardiac output
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.
Interventions
PROCEDUREFluid and inotropic/vasoactive management protocol
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
Sponsors
Khon Kaen University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
The patient is anesthetized, thus unaware type of treatment. The assessor is blinded of the monitor
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
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
1. 18-80 years old 2. Patient has ischemic or valvular heart disease 3. Scheduled for elective cardiac surgery 4. New York Heart Association (NYHA) or American society of Anesthesiology (ASA) classification I-III 5. Body mass index (BMI) 18-24 kg/m2 6. Provided informed consent before surgery
Exclusion criteria
1. Scheduled for emergency or redo surgery 2. Difficulty (or contraindication to) placing a central venous catheter 3. Inability to cooperate (e.g. mental disorder, disturbance of consciousness, mental retardation) 4. Presence of blood-borne infectious disease (e.g. syphilis, acquired immunodeficiency
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of inotropic/vaso active drugs requirement | up to Day 1 postoperatively | number of inotropic/vasoactive drugs required to maintain normal blood pressure and heart rate |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| ICU stay | up to day 10 postoperatively | number of hours admitted in ICU |
| Lactate level | up to Day 1 postoperatively | serum lactate level |
| Creatinine level | up to day 10 postoperatively | serum creatinine level |
Countries
Thailand
Outcome results
None listed