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

Sponsor
Shanghai Zhongshan Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT04102072
Collaborator
(none)
20
1
2
59.3
0.3

Study Details

Study Description

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

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: Trendelenburg Maneuver
  • Diagnostic Test: dobutamine stress test
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
20 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
The Consistency of Cardiac Output Measurements by Different Methods in VA-ECMO Patients
Actual Study Start Date :
Aug 23, 2019
Anticipated Primary Completion Date :
Aug 1, 2024
Anticipated Study Completion Date :
Aug 1, 2024

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Baseline Cardiac Output measurement [within1 minute at baseline position]

    Cardiac Output measured at baseline position( in a supine position with the head elevated to 15° for baseline measurements )

  2. Cardiac Output measurement afterTrendelenburg Maneuver [1 minute after starting Trendelenburg Maneuver]

    Cardiac Output measured after Trendelenburg Maneuver

  3. Cardiac Output measurement after Dobutamine stress test [5 minutes after dobutamine stress test]

    Cardiac Output measured after dobutamine stress test

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Zhongshan hospital, Fudan university Shanghai China 200032

Sponsors and Collaborators

  • Shanghai Zhongshan Hospital

Investigators

  • Study Chair: Zhe Luo, Doctor, Fudan University

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Shanghai Zhongshan Hospital
ClinicalTrials.gov Identifier:
NCT04102072
Other Study ID Numbers:
  • COMMENT
First Posted:
Sep 25, 2019
Last Update Posted:
Sep 26, 2019
Last Verified:
Sep 1, 2019
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Shanghai Zhongshan Hospital
Additional relevant MeSH terms:

Study Results

No Results Posted as of Sep 26, 2019