Transpulmonary Thermodilution and Transesophageal Echocardiography in Early Septic Shock (HEMOSEPSIS)
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).
|Study Design:||Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||Hemodynamic Assessment With Transpulmonary Thermodilution and Transesophageal Echocardiography in Patients With Early Septic Shock|
- therapeutic procedure following the hemodynamic assessment [ Time Frame: 2 years ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]Efficacy (clinical problem solved) and tolerance (potential side-effects) of the therapeutic change.
|Study Start Date:||January 2011|
|Estimated Study Completion Date:||December 2014|
|Estimated Primary Completion Date:||January 2014 (Final data collection date for primary outcome measure)|
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.
Each patient will be assessed by both the transpulmonary thermodilution technique and TEE (H0). The two assessments will be performed in random order (central randomization stratified by participating center), but within 30 minutes (no change of ongoing treatment during the assessment period). Two investigators not involved in patient care and blinded to the results of the alternative technique will performed independently the hemodynamic assessment using one of the two modalities for hemodynamic assessment tested in the study. They will interpret the results at bedside and propose a therapeutic change to the attending physician, according to the hemodynamic profile. The latter will finally: precisely identify the clinical problem to be solved (e.g., therapeutic target of the Surviving Sepsis Campaign not reached, tissue hypoperfusion), choose a therapy adapted while taking into account the clinical scenario and the results of both the transpulmonary thermodilution and TEE, evaluate the efficacy of this treatment (problem solved or not) and its tolerance (potential side-effect attributable to the treatment). In addition, the presence or resolution of signs of tissue hypoperfusion will systematically be assessed at H6, H12 and H24. Primary and secondary outcomes will be assessed by an independent committee of experts.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01188993
|Contact: Philippe VIGNON, Professor||(+33)(0)email@example.com|
|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|