Clinical trial NCT01188993: Transpulmonary Thermodilution and Transesophageal Echocardiography in Early Septic Shock
Official title: Hemodynamic Assessment With Transpulmonary Thermodilution and Transesophageal Echocardiography in Patients With Early Septic Shock
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Septic Shock
Lead sponsor: University Hospital, Limoges
Sponsor class: OTHER
First posted: 2010-08-26
Enrollment: 153
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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).

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* ventilated patient in sinus rhythm with septic shock requiring a hemodynamic assessment

Exclusion Criteria:

* \< 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.

Primary outcomes:
measure: therapeutic procedure following the hemodynamic assessment
timeFrame: 2 years
Secondary outcomes:
measure: efficacy and safety of therapeutic intervention
timeFrame: 2 years
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: Bordeaux UH
city: Toulouse
country: France
facility: Toulouse UH
Study officials:
References:
citation: 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.