Early Goal Directed Therapy in Cardiac Surgery

Postoperative Outcome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04292951
• Other study ID #: HE611321
• Status: Completed
• Phase: N/A
• Start date: January 1, 2020
• Est. completion date: July 1, 2020

Study information

• Verified date: August 2020
• Source: Khon Kaen University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: July 1, 2020
• Est. primary completion date: June 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• ICU Stay
• Postoperative Outcome

Intervention

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

Locations

Country	Name	City	State
Thailand	Faculty of Medicine, Khon Kaen University	Khon Kaen

Sponsors (1)

Lead Sponsor	Collaborator
Khon Kaen University

Country where clinical trial is conducted

Thailand, 

References & Publications (4)

Bednarczyk JM, Fridfinnson JA, Kumar A, Blanchard L, Rabbani R, Bell D, Funk D, Turgeon AF, Abou-Setta AM, Zarychanski R. Incorporating Dynamic Assessment of Fluid Responsiveness Into Goal-Directed Therapy: A Systematic Review and Meta-Analysis. Crit Care — View Citation

Kapoor PM, Kakani M, Chowdhury U, Choudhury M, Lakshmy, Kiran U. Early goal-directed therapy in moderate to high-risk cardiac surgery patients. Ann Card Anaesth. 2008 Jan-Jun;11(1):27-34. — View Citation

Kusaka Y, Ohchi F, Minami T. Evaluation of the Fourth-Generation FloTrac/Vigileo System in Comparison With the Intermittent Bolus Thermodilution Method in Patients Undergoing Cardiac Surgery. J Cardiothorac Vasc Anesth. 2019 Apr;33(4):953-960. doi: 10.105 — View Citation

Lopes MR, Oliveira MA, Pereira VO, Lemos IP, Auler JO Jr, Michard F. Goal-directed fluid management based on pulse pressure variation monitoring during high-risk surgery: a pilot randomized controlled trial. Crit Care. 2007;11(5):R100. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of inotropic/vaso active drugs requirement	number of inotropic/vasoactive drugs required to maintain normal blood pressure and heart rate	up to Day 1 postoperatively
Secondary	ICU stay	number of hours admitted in ICU	up to day 10 postoperatively
Secondary	Lactate level	serum lactate level	up to Day 1 postoperatively
Secondary	Creatinine level	serum creatinine level	up to day 10 postoperatively