Transpulmonary Thermodilution and Transesophageal Echocardiography in Early Septic Shock
HEMOSEPSIS
Hemodynamic Assessment With Transpulmonary Thermodilution and Transesophageal Echocardiography in Patients With Early Septic Shock
1 other identifier
interventional
153
1 country
2
Brief Summary
The purpose of this study is to assess the concordance of therapeutic changes proposed after an early hemodynamic evaluation (hemodynamic profile) in septic shock patients using jointly the transpulmonary thermodilution technique and transesophageal echocardiography (TEE).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Jan 2011
Longer than P75 for phase_4
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 25, 2010
CompletedFirst Posted
Study publicly available on registry
August 26, 2010
CompletedStudy Start
First participant enrolled
January 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2014
CompletedAugust 22, 2018
August 1, 2010
3 years
August 25, 2010
August 20, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
therapeutic procedure following the hemodynamic assessment
Changes in therapy proposed after the hemodynamic assessment (hemodynamic profile) by each of the two tested methods: blood volume expansion (preload responsiveness), positive inotrope (cardiac dysfunction), vasopressor (vasoplegia), no change in ongoing therapy or dose tapering (inotropes or vasopressor).
2 years
Secondary Outcomes (1)
efficacy and safety of therapeutic intervention
2 years
Study Arms (2)
septic shock TPT then TEE
ACTIVE COMPARATORGroup 1: Each patient will be assessed by both the transpulmonary thermodilution technique and transesophageal echocardiography (TEE)..
septic shock TEE then TPT
ACTIVE COMPARATORGoup 2: Each patient will be assessed by both transesophageal echocardiography (TEE) and the transpulmonary thermodilution technique.
Interventions
Each patient will be assessed by both the transpulmonary thermodilution and Transesophageal Echocardiography.
Eligibility Criteria
You may qualify if:
- ventilated patient in sinus rhythm with septic shock requiring a hemodynamic assessment
You may not qualify if:
- \< 18 yr-old
- pregnancy
- contra-indication for TEE, non sinus rhythm, aplasia, prior participation to the study, hemodynamic assessment using any other technique than those tested in the study.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (2)
Bordeaux UH
Bordeaux, 33 076, France
Toulouse UH
Toulouse, 31 059, France
Related Publications (1)
Vignon P, Begot E, Mari A, Silva S, Chimot L, Delour P, Vargas F, Filloux B, Vandroux D, Jabot J, Francois B, Pichon N, Clavel M, Levy B, Slama M, Riu-Poulenc B. Hemodynamic Assessment of Patients With Septic Shock Using Transpulmonary Thermodilution and Critical Care Echocardiography: A Comparative Study. Chest. 2018 Jan;153(1):55-64. doi: 10.1016/j.chest.2017.08.022. Epub 2017 Sep 1.
PMID: 28866112RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 25, 2010
First Posted
August 26, 2010
Study Start
January 1, 2011
Primary Completion
January 1, 2014
Study Completion
December 1, 2014
Last Updated
August 22, 2018
Record last verified: 2010-08