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

Not Applicable

• Conditions: Cardiac Output; Cardiac Surgery
• Interventions: Diagnostic Test: Passive Leg Raising; Diagnostic Test: Dobutamine stress test

• Registration Number: NCT04604886
• Lead Sponsor: Shanghai Zhongshan Hospital

Brief 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

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 Timeline

• Study Start: 2020-09-30
• Status Verified: 2020-10
• Study First Submitted: 2020-10-21
• Study First Submitted QC: 2020-10-21
• Study First Posted: 2020-10-27
• Last Update Submitted: 2020-10-27
• Last Update Posted: 2020-10-29
• Primary Completion: 2024-06-30
• Study Completion: 2024-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Passive Leg Raising	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.
Dobutamine stress test	Dobutamine stress test	Dobutamine is a selective beta 1 receptor agonist. It \[\<10 ug/(kg.min)\] can effectively increase myocardial contractility.

Primary Outcome Measures

Name	Time	Method
Cardiac Output measurement after PLR	1 minute after PLR	Cardiac Output measured after PLR
Baseline Cardiac Output measurement	within1 minute at baseline position	Cardiac Output measured at baseline position (horizontal position)
Cardiac Output measurement after Dobutamine stress test	5 minutes after dobutamine stress test	Cardiac Output measured after dobutamine stress test

Trial Locations

Locations (1)

180 Fenglin Road; 🇨🇳 Shanghai, China