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

Cardiac Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04604886
• Other study ID #: COMPACT-LiDCO
• Status: Recruiting
• Phase: N/A
• Start date: September 30, 2020
• Est. completion date: June 30, 2024

Study information

• Verified date: October 2020
• Source: Shanghai Zhongshan Hospital
• Contact: Guo-wei Tu, Doctor
• Phone: 86-021-64041990
• Email: tu.guowei[@]zs-hospital.sh.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: June 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Cardiac Output
• Cardiac Surgery

Intervention

Diagnostic Test:
• Passive Leg Raising
Passive leg raising is induced by rasing the legs of patients to 45° from horizontal position.
• 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.

Locations

Country	Name	City	State
China	180 Fenglin Road	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Zhongshan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Baseline Cardiac Output measurement	Cardiac Output measured at baseline position (horizontal position)	within1 minute at baseline position
Primary	Cardiac Output measurement after PLR	Cardiac Output measured after PLR	1 minute after PLR
Primary	Cardiac Output measurement after Dobutamine stress test	Cardiac Output measured after dobutamine stress test	5 minutes after dobutamine stress test