NCT04292951

Early Goal Directed Therapy in Cardiac Surgery

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 80 (actual)
• Sponsor: Khon Kaen University · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Postoperative Outcome
• ICU Stay

Interventions

Type	Name	Description
PROCEDURE	Fluid 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

Timeline

• Start date: 2020-01-01
• Primary completion: 2020-06-01
• Completion: 2020-07-01
• First posted: 2020-03-03
• Last updated: 2020-09-02

Locations

1 site across 1 country: Thailand