Early Goal Directed Therapy in Cardiac Surgery

Not Applicable

Completed

• Conditions: Postoperative Outcome; ICU Stay
• Interventions: Procedure: Fluid and inotropic/vasoactive management protocol

• Registration Number: NCT04292951
• Lead Sponsor: Khon Kaen University

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.

Study Timeline

• Study Start: 2020-01-01
• Study First Submitted: 2020-03-01
• Study First Submitted QC: 2020-03-01
• Study First Posted: 2020-03-03
• Primary Completion: 2020-06-01
• Study Completion: 2020-07-01
• Status Verified: 2020-08
• Last Update Submitted: 2020-08-31
• Last Update Posted: 2020-09-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
GDT group	Fluid and inotropic/vasoactive management protocol	Intraoperative fluid and inotropic/vasoactive drugs management based on information from FloTrac/EV1000
Control group	Fluid and inotropic/vasoactive management protocol	Intraoperative fluid and inotropic/vasoactive drugs management based on CVP, blood pressure, heart rate, and clinical signs at the discretion of attending anesthesiologists

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Creatinine level	up to day 10 postoperatively	serum creatinine level
ICU stay	up to day 10 postoperatively	number of hours admitted in ICU
Lactate level	up to Day 1 postoperatively	serum lactate level

Trial Locations

Locations (1)

Faculty of Medicine, Khon Kaen University; 🇹🇭 Khon Kaen, Thailand