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

NCT ID: NCT03553459

Last Updated: 2019-10-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-07-01

Study Completion Date

2022-12-30

Brief Summary

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

Detailed Description

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Conditions

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Extracorporeal Membrane Oxygenation

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Trendelenburg Maneuver

Intervention Type DIAGNOSTIC_TEST

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.

Interventions

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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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shanghai Zhongshan Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Zhe Luo, Doctor

Role: STUDY_CHAIR

Fudan University

Locations

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Zhongshan hospital, Fudan university

Shanghai, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Guo-wei Tu, Doctor

Role: CONTACT

86-021-64041990

Facility Contacts

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Zhe Luo, Docttor

Role: primary

86-021-64041990

References

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Luo JC, Su Y, Dong LL, Hou JY, Li X, Zhang Y, Ma GG, Zheng JL, Hao GW, Wang H, Zhang YJ, Luo Z, Tu GW. Trendelenburg maneuver predicts fluid responsiveness in patients on veno-arterial extracorporeal membrane oxygenation. Ann Intensive Care. 2021 Jan 26;11(1):16. doi: 10.1186/s13613-021-00811-x.

Reference Type DERIVED
PMID: 33496906 (View on PubMed)

Other Identifiers

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TEMPLE

Identifier Type: -

Identifier Source: org_study_id

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