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

NCT04604886 | Unknown DMC

• 1 other identifier: COMPACT-LiDCO
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Cardiac Surgery; Cardiac Output

Keywords

Hemodynamic Monitoring; Pulmonary artery catherization; LiDCO

Outcome Measures

Primary Outcomes (3)

• 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

• Cardiac Output measurement after Dobutamine stress test

  Cardiac Output measured after dobutamine stress test

  5 minutes after dobutamine stress test

Study Arms (2)

Passive Leg Raising

EXPERIMENTAL

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

Dobutamine stress test

EXPERIMENTAL

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

Diagnostic Test: Dobutamine stress test

Interventions

Passive Leg Raising DIAGNOSTIC_TEST

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

Passive Leg Raising

Dobutamine stress test 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.

Dobutamine stress test

Eligibility Criteria

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

You may qualify if:

• cardiac surgery
• hemodynamic monitoring (PAC, LiDCO)
• mechanical ventilation

You may not qualify if:

• cardiac arrhythmia
• moderate to severe aortic, mitral and tricuspid regurgitation
• IABP
• ECMO

Sponsors & Collaborators

• Shanghai Zhongshan Hospital: lead

Study Sites (1)

180 Fenglin Road

Shanghai, 200032, China

RECRUITING

Study Officials

• Zhe Luo, Doctor

  Fudan University

  STUDY CHAIR

Central Study Contacts

Guo-wei Tu, Doctor

CONTACT

86-021-64041990; tu.guowei@zs-hospital.sh.cn

Yijie Zhang, Doctor

CONTACT

86-021-64041990; zhang.yijie@zs-hospital.sh.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 21, 2020
• First Posted: October 27, 2020
• Study Start: September 30, 2020
• Primary Completion: June 30, 2024
• Study Completion: June 30, 2024
• Last Updated: October 29, 2020

Record last verified: 2020-10

Locations

CN (1)