Trendelenburg Maneuver Predicts Fluid Responsiveness in Patients With Extracorporeal Membrane Oxygenation (TEMPLE)
Hemodynamic Changes Induced by Trendelenburg Maneuver to Predict Fluid Responsiveness in Patients With Extracorporeal Membrane Oxygenation
1 other identifier
interventional
40
1 country
1
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
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jul 2018
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 30, 2018
CompletedFirst Posted
Study publicly available on registry
June 12, 2018
CompletedStudy Start
First participant enrolled
July 1, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 30, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 30, 2022
CompletedOctober 8, 2019
October 1, 2019
4.5 years
May 30, 2018
October 4, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
responders
responders are defined by stroke volume increases over 15% after volume expansion of 500ml crystalloid
within 1 minute after volume expansion
nonresponders
nonresponders are defined by stroke volume increases less than 15% after volume expansion of 500ml crystalloid
within 1 minute after volume expansion
Study Arms (1)
Trendelenburg Maneuver
EXPERIMENTALTrendelenburg 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- patients with ECMO and mechanical ventilator support
- hypotension (MAP\<65mmHg)
- required volume expansion by clinical judgement of the intensivists
You may not qualify if:
- severe hypotension with high dose of vasopressors
- severe valve regurgitation
- cardiac arrhythmia
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Zhongshan hospital, Fudan university
Shanghai, 200032, China
Related Publications (1)
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.
PMID: 33496906DERIVED
Study Officials
- STUDY CHAIR
Zhe Luo, Doctor
Fudan University
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 30, 2018
First Posted
June 12, 2018
Study Start
July 1, 2018
Primary Completion
December 30, 2022
Study Completion
December 30, 2022
Last Updated
October 8, 2019
Record last verified: 2019-10