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

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

Study Overview

• Status: Recruiting
• Conditions: Extracorporeal Membrane Oxygenation
• Intervention / Treatment: Diagnostic test: Trendelenburg Maneuver; Diagnostic test: dobutamine stress test

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.

• Study Type: Interventional
• Enrollment (Anticipated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jun-yi Hou, Doctor; Phone Number: 86-021-64041990; Email: hou.junyi@zs-hospital.sh.cn

Study Locations

• China
  • Shanghai, China, 200032
    • Recruiting
    • Zhongshan Hospital, Fudan University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Diagnostic test: 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.
Experimental: dobutamine stress test; Dobutamine is a selective beta 1 receptor agonist. It [<10 ug/(kg.min)] can effectively increase myocardial contractility.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Baseline Cardiac Output measurement	Cardiac Output measured at baseline position（ in a supine position with the head elevated to 15° for baseline measurements ）	within1 minute at baseline position
Cardiac Output measurement afterTrendelenburg Maneuver	Cardiac Output measured after Trendelenburg Maneuver	1 minute after starting Trendelenburg Maneuver
Cardiac Output measurement after Dobutamine stress test	Cardiac Output measured after dobutamine stress test	5 minutes after dobutamine stress test

Collaborators and Investigators

• Sponsor: Shanghai Zhongshan Hospital

Study record dates

Study Major Dates

• Study Start (Actual): August 23, 2019
• Primary Completion (Anticipated): August 1, 2024
• Study Completion (Anticipated): August 1, 2024

Study Registration Dates

• First Submitted: September 10, 2019
• First Submitted That Met QC Criteria: September 22, 2019
• First Posted (Actual): September 25, 2019

Study Record Updates

• Last Update Posted (Actual): September 26, 2019
• Last Update Submitted That Met QC Criteria: September 24, 2019
• Last Verified: September 1, 2019

More Information

Terms related to this study

• Keywords: echocardiography; fluid responsiveness; extracorporeal membrane oxygenation; pulmonary artery catheter
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Autonomic Agents; Peripheral Nervous System Agents; Protective Agents; Adrenergic Agonists; Cardiotonic Agents; Adrenergic beta-Agonists; Sympathomimetics; Adrenergic beta-1 Receptor Agonists; Dobutamine
• Other Study ID Numbers: COMMENT

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No