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Completed

NCT Number: NCT01188993

Transpulmonary Thermodilution and Transesophageal Echocardiography in Early Septic Shock

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).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Bordeaux UH, Bordeaux, France

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

early septic shock

Combination Product

Each patient will be assessed by both the transpulmonary thermodilution and Transesophageal Echocardiography.

Primary outcomes

  1. therapeutic procedure following the hemodynamic assessment

    Time frame: 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 outcomes

  1. efficacy and safety of therapeutic intervention

    Time frame: 2 years

    Efficacy (clinical problem solved) and tolerance (potential side-effects) of the therapeutic change.

Sponsors and collaborators

Lead sponsor

University Hospital, Limoges

Other

Registry information

Official study title

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

Acronym: HEMOSEPSIS

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Aug 26, 2010
Registry last updated
Aug 22, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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