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

NCT ID: NCT04604886

Last Updated: 2020-10-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-09-30

Study Completion Date

2024-06-30

Brief Summary

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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

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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.

Conditions

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Cardiac Surgery Cardiac Output

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Passive Leg Raising

Intervention Type DIAGNOSTIC_TEST

Passive leg raising is induced by rasing the legs of patients to 45° from horizontal position.

Dobutamine stress test

Dobutamine is a selective beta 1 receptor agonist. It \[\<10 ug/(kg.min)\] can effectively increase myocardial contractility.

Group Type EXPERIMENTAL

Dobutamine stress test

Intervention Type DIAGNOSTIC_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.

Interventions

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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.

Intervention Type DIAGNOSTIC_TEST

Passive Leg Raising

Passive leg raising is induced by rasing the legs of patients to 45° from horizontal position.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shanghai Zhongshan Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Zhe Luo, Doctor

Role: STUDY_CHAIR

Fudan University

Locations

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180 Fenglin Road

Shanghai, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Guo-wei Tu, Doctor

Role: CONTACT

[email protected]
86-021-64041990

Yijie Zhang, Doctor

Role: CONTACT

[email protected]
86-021-64041990

Facility Contacts

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Guo-wei Tu, Doctor

Role: primary

[email protected]
86-021-64041990

Other Identifiers

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COMPACT-LiDCO

Identifier Type: -

Identifier Source: org_study_id