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Completed

NCT Number: NCT04292951

Early Goal Directed Therapy in Cardiac Surgery

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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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty of Medicine, Khon Kaen University

Khon Kaen, 40002, Thailand

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 18-80 years old
  • Patient has ischemic or valvular heart disease
  • Scheduled for elective cardiac surgery
  • New York Heart Association (NYHA) or American society of Anesthesiology (ASA) classification I-III
  • Body mass index (BMI) 18-24 kg/m2
  • Provided informed consent before surgery

Exclusion criteria

  • Scheduled for emergency or redo surgery
  • Difficulty (or contraindication to) placing a central venous catheter
  • Inability to cooperate (e.g. mental disorder, disturbance of consciousness, mental retardation)
  • Presence of blood-borne infectious disease (e.g. syphilis, acquired immunodeficiency

Treatment and study plan

Fluid and inotropic/vasoactive management protocol

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

Primary outcomes

  1. Number of inotropic/vaso active drugs requirement

    Time frame: up to Day 1 postoperatively

    number of inotropic/vasoactive drugs required to maintain normal blood pressure and heart rate

Secondary outcomes

  1. ICU stay

    Time frame: up to day 10 postoperatively

    number of hours admitted in ICU

  2. Lactate level

    Time frame: up to Day 1 postoperatively

    serum lactate level

  3. Creatinine level

    Time frame: up to day 10 postoperatively

    serum creatinine level

Sponsors and collaborators

Lead sponsor

Khon Kaen University

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Mar 3, 2020
Registry last updated
Sep 2, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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