The Consistency of Cardiac Output Measured by Pulmonary Artery Catheter and LiDCO in Cardiac Surgical Patients

1. To evaluate the consistency of cardiac output measured by pulmonary artery catheter and LiDCO in cardiac surgical patients
2. To evaluate whether different hemodynamic monitoring methods can accurately detect the trend of cardiac output changes

Study Overview

• Status: Recruiting
• Conditions: Cardiac Surgery; Cardiac Output
• Intervention / Treatment: Diagnostic test: Passive Leg Raising; Diagnostic test: Dobutamine stress test

Detailed Description

Close monitoring of cardiac output (CO), especially in patients before and after intervention(such as volume expansion, diuresis, vasoconstriction, vasodilation therapy), could help to adjust the treatment strategy in cardiac surgical patients. Pulmonary artery catherization (PAC) has been used for hemodynamic monitoring for more than four decades. In spite of its invasiveness, it remains the clinical reference method for the assessment of CO at the bedside. Nowadays, many less invasive alternatives, such as LiDCO Rapid Pulse Contour Analysis System (LiDCO Ltd., Cambridge, United Kingdom), are already available on market. However, consistency between different hemodynamic monitoring results still raise concern. And whether hemodynamic monitoring could accurately detect the changes of these parameters before and after intervention is an important issue in clinical practice. In this study, the investigators are going to collect CO and changes of CO from PAC and LiDCO before and after intervention (passive leg raising and dobutamine stress test) in cardiac surgical patients. Our resulst could provide important reference for cardiac surgical patients how to choose appropriate hemodynamic monitoring tools and how to interpret the results of hemodynamic monitoring.

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yijie Zhang, Doctor; Phone Number: 86-021-64041990; Email: zhang.yijie@zs-hospital.sh.cn

Study Locations

• China
  • Shanghai, China, 200032
    • Recruiting
    • 180 Fenglin Road

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. cardiac surgery
2. hemodynamic monitoring (PAC, LiDCO)
3. mechanical ventilation

Exclusion Criteria:

1. cardiac arrhythmia
2. moderate to severe aortic, mitral and tricuspid regurgitation
3. IABP
4. ECMO

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Passive Leg Raising; Passive leg raising (PLR) test is used to predict fluid responsiveness, which is performed by raising the legs of the patient to 45°. Cardiac output will be collected from both PAC and LiDCO before and after PLR.	Diagnostic test: Passive Leg Raising; Passive leg raising is induced by rasing the legs of patients to 45° from horizontal position.
Experimental: Dobutamine stress test; Dobutamine is a selective beta 1 receptor agonist. It [<10 ug/(kg.min)] can effectively increase myocardial contractility.	Diagnostic test: Dobutamine stress test; Dobutamine was infused intravenously at the initial dose of 2.5 ug/kg/min. hemodynamic data were recorded from PAC and LiDCO after 5-10 minutes of continuous infusion.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cardiac Output measurement after Dobutamine stress test	Cardiac Output measured after dobutamine stress test	5 minutes after dobutamine stress test
Baseline Cardiac Output measurement	Cardiac Output measured at baseline position (horizontal position)	within1 minute at baseline position
Cardiac Output measurement after PLR	Cardiac Output measured after PLR	1 minute after PLR

Collaborators and Investigators

• Sponsor: Shanghai Zhongshan Hospital

Study record dates

Study Major Dates

• Study Start (Actual): September 30, 2020
• Primary Completion (Anticipated): June 30, 2024
• Study Completion (Anticipated): June 30, 2024

Study Registration Dates

• First Submitted: October 21, 2020
• First Submitted That Met QC Criteria: October 21, 2020
• First Posted (Actual): October 27, 2020

Study Record Updates

• Last Update Posted (Actual): October 29, 2020
• Last Update Submitted That Met QC Criteria: October 27, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Keywords: Hemodynamic Monitoring; LiDCO; Pulmonary artery catherization
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Protective Agents; Adrenergic Agonists; Cardiotonic Agents; Adrenergic beta-Agonists; Sympathomimetics; Adrenergic beta-1 Receptor Agonists; Dobutamine
• Other Study ID Numbers: COMPACT-LiDCO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No