Early Goal Directed Therapy in Cardiac Surgery

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-01

Study Completion Date

2020-07-01

Brief Summary

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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.

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Detailed Description

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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

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Postoperative Outcome ICU Stay

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

The patient is anesthetized, thus unaware type of treatment. The assessor is blinded of the monitor

Study Groups

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GDT group

Intraoperative fluid and inotropic/vasoactive drugs management based on information from FloTrac/EV1000

Group Type EXPERIMENTAL

Fluid and inotropic/vasoactive management protocol

Intervention Type PROCEDURE

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

Control group

Intraoperative fluid and inotropic/vasoactive drugs management based on CVP, blood pressure, heart rate, and clinical signs at the discretion of attending anesthesiologists

Group Type ACTIVE_COMPARATOR

Fluid and inotropic/vasoactive management protocol

Intervention Type PROCEDURE

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

Interventions

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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

Intervention Type PROCEDURE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No