The Consistency of Cardiac Output Measurements by Different Methods in VA-ECMO Patients

NCT ID: NCT04102072

Last Updated: 2019-09-26

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-08-23
• Study Completion Date: 2024-08-31

Brief Summary

Objective：

1. To evaluate the consistency of cardiac output measured by different hemodynamic monitoring methods in patients with VA-ECMO

2. To evaluate whether different hemodynamic monitoring methods can accurately detect the trend of cardiac output changes

Detailed Description

Venoarterial extracorporeal membrane oxygenation (VA-ECMO) has been used for profound cardiogenic shock to bridge to decision,ventricular assist devices,or transplant.Close monitoring of cardiac output, especially in patients before and after intervention (such as volume expansion, diuresis, vasoconstriction, vasodilation therapy), can help to adjust the treatment strategy. Hemodynamic monitoring in ECMO patients requires familiarity with the underlying pathophysiology and circulatory mechanics of extracorporeal flow.Limited to the actual clinical situation of patients, one or two hemodynamic monitoring methods may be accepted. Is there consistency between different hemodynamic monitoring results? And whether hemodynamic monitoring can accurately detect the changes of these parameters before and after intervention is an important issue in clinical practice. This study will provide important reference for VA-ECMO patients how to choose appropriate hemodynamic monitoring tools and how to interpret the results of hemodynamic monitoring.

Conditions

Extracorporeal Membrane Oxygenation

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Trendelenburg Maneuver

The Trendelenburg position is a common treatment in medicine.It is used either as a diagnostic tool to assess fluid loading response or as a therapeutic maneuver pending fluid resuscitation.With the advantage of autotransfusion readily available,the Trendelenburg position is used for expected instantaneous effect on cardiovascular performance.

Group Type: EXPERIMENTAL

Trendelenburg Maneuver

Intervention Type: DIAGNOSTIC_TEST

In the Trendelenburg position, the body is laid supine with the feet higher than the head by 15-30 degrees. The venous return increases in the trendelenburg position which in turn increases the stroke volume.

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. Echocardiography was performed after 5-10 minutes of continuous infusion, and hemodynamic data were recorded.

Interventions

Trendelenburg Maneuver

In the Trendelenburg position, the body is laid supine with the feet higher than the head by 15-30 degrees. The venous return increases in the trendelenburg position which in turn increases the stroke volume.

Intervention Type: DIAGNOSTIC_TEST

dobutamine stress test

Dobutamine was infused intravenously at the initial dose of 2.5 ug/kg/min. Echocardiography was performed after 5-10 minutes of continuous infusion, and hemodynamic data were recorded.

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

1. cardiac surgery

2. treatment with VA-ECMO

3. mechanical ventilation

4. hemodynamic monitoring according to patient's condition (PAC, Flotrac, echocardiography)

Exclusion Criteria

1. age < 18

2. cardiac arrhythmia

3. moderate to severe aortic, mitral and tricuspid regurgitation

4. active hemorrhage

5. IABP

6. spontaneous triggering of the ventilator

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Zhongshan Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Zhe Luo, Doctor

Role: STUDY_CHAIR

Fudan University

Locations

Zhongshan hospital, Fudan university

Shanghai, , China

Site Status: RECRUITING

Countries

China

Central Contacts

Guo-wei Tu, Doctor

Role: CONTACT

tu.guowei@zs-hospital.sh.cn

86-021-64041990

Jun-yi Hou, Doctor

Role: CONTACT

hou.junyi@zs-hospital.sh.cn

86-021-64041990

Facility Contacts

Guo-wei Tu, Doctor

Role: primary

tu.guowei@zs-hospital.sh.cn

86-021-64041990

Other Identifiers

COMMENT

Identifier Type: -

Identifier Source: org_study_id