Transpulmonary Thermodilution and Transesophageal Echocardiography in Early Septic Shock (HEMOSEPSIS)
|ClinicalTrials.gov Identifier: NCT01188993|
Recruitment Status : Unknown
Verified August 2010 by University Hospital, Limoges.
Recruitment status was: Recruiting
First Posted : August 26, 2010
Last Update Posted : November 1, 2013
|Condition or disease||Intervention/treatment||Phase|
|Septic Shock||Other: early septic shock||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||153 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Hemodynamic Assessment With Transpulmonary Thermodilution and Transesophageal Echocardiography in Patients With Early Septic Shock|
|Study Start Date :||January 2011|
|Estimated Primary Completion Date :||January 2014|
|Estimated Study Completion Date :||December 2014|
Each patient will be assessed by both the transpulmonary thermodilution technique and TEE.
Other: early septic shock
Each patient will be assessed by both the transpulmonary thermodilution and Transesophageal Echocardiography.
- therapeutic procedure following the hemodynamic assessment [ Time Frame: 2 years ]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).
- efficacy and safety of therapeutic intervention [ Time Frame: 2 years ]Efficacy (clinical problem solved) and tolerance (potential side-effects) of the therapeutic change.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01188993
|Contact: Philippe VIGNON, Professor||(+33)(0)firstname.lastname@example.org|
|Bordeaux, France, 33 076|
|Contact: Frédéric Vargas, Doctor (+33)(0)556795517|
|Principal Investigator: Frédéric VARGAS, Doctor|
|Toulouse, France, 31 059|
|Contact: Michelle GENESTAL, Professor (+33)(0)561772288|
|Principal Investigator: Michelle GENESTAL, Professor|