Transpulmonary Thermodilution and Transesophageal Echocardiography in Early Septic Shock

Phase 4

Completed

• Conditions: Septic Shock
• Interventions: Combination Product: early septic shock

• Registration Number: NCT01188993
• Lead Sponsor: University Hospital, Limoges

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.

Study Timeline

• Status Verified: 2010-08
• Study First Submitted: 2010-08-25
• Study First Submitted QC: 2010-08-25
• Study First Posted: 2010-08-26
• Study Start: 2011-01
• Primary Completion: 2014-01
• Study Completion: 2014-12
• Last Update Submitted: 2018-08-20
• Last Update Posted: 2018-08-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 153

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
septic shock TPT then TEE	early septic shock	Group 1: Each patient will be assessed by both the transpulmonary thermodilution technique and transesophageal echocardiography (TEE)..
septic shock TEE then TPT	early septic shock	Goup 2: Each patient will be assessed by both transesophageal echocardiography (TEE) and the transpulmonary thermodilution technique.

Primary Outcome Measures

Name	Time	Method
therapeutic procedure following the hemodynamic assessment	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).

Secondary Outcome Measures

Name	Time	Method
efficacy and safety of therapeutic intervention	2 years	Efficacy (clinical problem solved) and tolerance (potential side-effects) of the therapeutic change.

Trial Locations

Locations (2)

Bordeaux UH; 🇫🇷 Bordeaux, France

Toulouse UH; 🇫🇷 Toulouse, France