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Transpulmonary Thermodilution and Transesophageal Echocardiography in Early Septic Shock (HEMOSEPSIS)

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2010 by University Hospital, Limoges
Sponsor:
Information provided by (Responsible Party):
University Hospital, Limoges
ClinicalTrials.gov Identifier:
NCT01188993
First received: August 25, 2010
Last updated: October 31, 2013
Last verified: August 2010
  Purpose

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).


Condition Intervention Phase
Septic Shock
Other: early septic shock
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Hemodynamic Assessment With Transpulmonary Thermodilution and Transesophageal Echocardiography in Patients With Early Septic Shock

Resource links provided by NLM:


Further study details as provided by University Hospital, Limoges:

Primary Outcome Measures:
  • therapeutic procedure following the hemodynamic assessment [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    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:
  • efficacy and safety of therapeutic intervention [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    Efficacy (clinical problem solved) and tolerance (potential side-effects) of the therapeutic change.


Estimated Enrollment: 153
Study Start Date: January 2011
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
septic shock
Each patient will be assessed by both the transpulmonary thermodilution technique and TEE.
Other: early septic shock
Each patient will be assessed by both the transpulmonary thermodilution and Transesophageal Echocardiography.

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01188993

Contacts
Contact: Philippe VIGNON, Professor (+33)(0)555056240 philippe.vignon@unilim.fr

Locations
France
Bordeaux UH Recruiting
Bordeaux, France, 33 076
Contact: Frédéric Vargas, Doctor    (+33)(0)556795517      
Principal Investigator: Frédéric VARGAS, Doctor         
Toulouse UH Recruiting
Toulouse, France, 31 059
Contact: Michelle GENESTAL, Professor    (+33)(0)561772288      
Principal Investigator: Michelle GENESTAL, Professor         
Sponsors and Collaborators
University Hospital, Limoges
  More Information

No publications provided

Responsible Party: University Hospital, Limoges
ClinicalTrials.gov Identifier: NCT01188993     History of Changes
Other Study ID Numbers: I09003
Study First Received: August 25, 2010
Last Updated: October 31, 2013
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:
Shock
Shock, Septic
Infection
Inflammation
Pathologic Processes
Sepsis
Systemic Inflammatory Response Syndrome

ClinicalTrials.gov processed this record on November 23, 2014