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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| septic shock TPT then TEE | Active Comparator | Group 1: Each patient will be assessed by both the transpulmonary thermodilution technique and transesophageal echocardiography (TEE).. |
|
| septic shock TEE then TPT | Active Comparator | Goup 2: Each patient will be assessed by both transesophageal echocardiography (TEE) and the transpulmonary thermodilution technique. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| early septic shock | Combination Product | Each patient will be assessed by both the transpulmonary thermodilution and Transesophageal Echocardiography. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| efficacy and safety of therapeutic intervention | Efficacy (clinical problem solved) and tolerance (potential side-effects) of the therapeutic change. | 2 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bordeaux UH | Bordeaux | 33 076 | France | |||
| Toulouse UH |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28866112 | Result | 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. |
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| ID | Term |
|---|---|
| D012772 | Shock, Septic |
| ID | Term |
|---|---|
| D018805 | Sepsis |
| D007239 | Infections |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
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| Toulouse |
| 31 059 |
| France |
| D010335 |
| Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012769 | Shock |