Transpulmonary Thermodilution and Transesophageal Echocardiography in Early Septic Shock

Septic Shock Clinical Trial

— HEMOSEPSIS  

Official title:

Hemodynamic Assessment With Transpulmonary Thermodilution and Transesophageal Echocardiography in Patients With Early Septic Shock

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01188993
• Other study ID #: I09003
• Status: Completed
• Phase: Phase 4
• Start date: January 2011
• Est. completion date: December 2014

Study information

• Verified date: August 2010
• Source: University Hospital, Limoges
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 153
• Est. completion date: December 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Septic Shock
• Shock
• Shock, Septic

Intervention

Combination Product:
• early septic shock
Each patient will be assessed by both the transpulmonary thermodilution and Transesophageal Echocardiography.

Locations

Country	Name	City	State
France	Bordeaux UH	Bordeaux
France	Toulouse UH	Toulouse

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Limoges

Country where clinical trial is conducted

France, 

References & Publications (1)

Vignon P, Begot E, Mari A, Silva S, Chimot L, Delour P, Vargas F, Filloux B, Vandroux D, Jabot J, François B, Pichon N, Clavel M, Levy B, Slama M, Riu-Poulenc B. Hemodynamic Assessment of Patients With Septic Shock Using Transpulmonary Thermodilution and — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	efficacy and safety of therapeutic intervention	Efficacy (clinical problem solved) and tolerance (potential side-effects) of the therapeutic change.	2 years