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Trendelenburg Maneuver Predicts Fluid Responsiveness in Patients With Extracorporeal Membrane Oxygenation (TEMPLE)

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ClinicalTrials.gov Identifier: NCT03553459
Recruitment Status : Recruiting
First Posted : June 12, 2018
Last Update Posted : October 8, 2019
Sponsor:
Information provided by (Responsible Party):
Shanghai Zhongshan Hospital

Brief Summary:
The purpose of the study is to verify the efficacy of using trendelenburg maneuver to predict fluid responsiveness in patients with extracorporeal membrane oxygenation

Condition or disease Intervention/treatment Phase
Extracorporeal Membrane Oxygenation Diagnostic Test: Trendelenburg Maneuver Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Hemodynamic Changes Induced by Trendelenburg Maneuver to Predict Fluid Responsiveness in Patients With Extracorporeal Membrane Oxygenation
Actual Study Start Date : July 1, 2018
Estimated Primary Completion Date : December 30, 2022
Estimated Study Completion Date : December 30, 2022

Arm Intervention/treatment
Experimental: Trendelenburg Maneuver
Trendelenburg maneuver is performed to predict fluid responsiveness. Responders are defined by an increase in stroke volume over 15% after infusion of 500ml of crystalloid solution.
Diagnostic Test: Trendelenburg Maneuver
In the Trendelenburg position, the body is laid supine, or flat on the back 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.




Primary Outcome Measures :
  1. responders [ Time Frame: within 1 minute after volume expansion ]
    responders are defined by stroke volume increases over 15% after volume expansion of 500ml crystalloid

  2. nonresponders [ Time Frame: within 1 minute after volume expansion ]
    nonresponders are defined by stroke volume increases less than 15% after volume expansion of 500ml crystalloid



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • patients with ECMO and mechanical ventilator support
  • hypotension (MAP<65mmHg)
  • required volume expansion by clinical judgement of the intensivists

Exclusion Criteria:

  • severe hypotension with high dose of vasopressors
  • severe valve regurgitation
  • cardiac arrhythmia

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03553459


Contacts
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Contact: Guo-wei Tu, Doctor 86-021-64041990 tu.guowei@zs-hospital.sh.cn

Locations
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China
Zhongshan hospital, Fudan university Recruiting
Shanghai, China, 200032
Contact: Zhe Luo, Docttor    86-021-64041990    luo.zhe@zs-hospital.sh.cn   
Sponsors and Collaborators
Shanghai Zhongshan Hospital
Investigators
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Study Chair: Zhe Luo, Doctor Fudan University

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Responsible Party: Shanghai Zhongshan Hospital
ClinicalTrials.gov Identifier: NCT03553459     History of Changes
Other Study ID Numbers: TEMPLE
First Posted: June 12, 2018    Key Record Dates
Last Update Posted: October 8, 2019
Last Verified: October 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Shanghai Zhongshan Hospital:
fluid responsiveness
trendelenburg
extracorporeal membrane oxygenation