Early Goal Directed Therapy in Cardiac Surgery

NCT04292951 | Completed

• 1 other identifier: HE611321
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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.

Conditions

Postoperative Outcome; ICU Stay

Keywords

Postoperative outcome; Goal directed therapy; Arterial pressure derived cardiac output

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• ICU stay

  up to day 10 postoperatively

• Lactate level

  up to Day 1 postoperatively

• Creatinine level

  up to day 10 postoperatively

Study Arms (2)

GDT group

EXPERIMENTAL

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

Procedure: Fluid and inotropic/vasoactive management protocol

Control group

ACTIVE COMPARATOR

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

Procedure: Fluid and inotropic/vasoactive management protocol

Interventions

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

Control group; GDT group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Khon Kaen University: lead

Study Sites (1)

Faculty of Medicine, Khon Kaen University

Khon Kaen, 40002, Thailand

Location

Related Publications (5)

• 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 Med. 2017 Sep;45(9):1538-1545. doi: 10.1097/CCM.0000000000002554.

  PMID: 28817481 RESULT

• 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. doi: 10.4103/0971-9784.38446.

  PMID: 18182756 RESULT

• 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: 10.1053/j.jvca.2018.06.017. Epub 2018 Jun 28.

  PMID: 30077561 RESULT

• 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. doi: 10.1186/cc6117.

  PMID: 17822565 RESULT

• Tribuddharat S, Sathitkarnmanee T, Ngamsaengsirisup K, Sornpirom S. Efficacy of early goal-directed therapy using FloTrac/EV1000 to improve postoperative outcomes in patients undergoing off-pump coronary artery bypass surgery: a randomized controlled trial. J Cardiothorac Surg. 2022 Aug 21;17(1):196. doi: 10.1186/s13019-022-01933-4.

  PMID: 35989328 DERIVED

MeSH Terms

Interventions

Fluid Therapy

Intervention Hierarchy (Ancestors)

Drug Therapy; Therapeutics

Study Officials

• Thepakorn Sathitkarnmanee, MD

  Faculty of Medicine, Khon Kaen University, Khon Kaen, Thailand

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: The patient is anesthetized, thus unaware type of treatment. The assessor is blinded of the monitor
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Model Details: 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

Study Record Dates

• First Submitted: March 1, 2020
• First Posted: March 3, 2020
• Study Start: January 1, 2020
• Primary Completion: June 1, 2020
• Study Completion: July 1, 2020
• Last Updated: September 2, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)