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Early Haemodynamic Optimization Using Preload Dependence During Septic Shock = EHOSS-1 (EHOSS-1)

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ClinicalTrials.gov Identifier: NCT01972828
Recruitment Status : Completed
First Posted : October 31, 2013
Last Update Posted : October 31, 2013
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

Brief Summary:
Haemodynamic optimization is of paramount importance in septic shock, but is really consensual and standardized during the first 6 hours of treatment. Haemodynamic treatment including fluid loading management, vasoactive treatment and oxygen transport optimization is mainly based on expert recommendations or non-randomized trials. Recently, preload dependence indexes such as pulse pressure variation have been shown to be more accurate to predict fluid responsiveness than static indexes such as filling pressures. However, whether using preload dependence indexes changes septic shock prognostic remains to date unknown. The aim of this non-blinded randomized controlled trial is to assess whether haemodynamic optimization using preload dependence indexes and pulmonary thermodilution 1. reduces septic shock duration assessed by administration duration of vasoactive treatment (primary end point), 2. reduces regional hypoperfusion assessed by arterial lactate, 3. reduces lung hydrostatic oedema linked to excessive fluid loading (assessed by PaO2/FIO2 ratio and extravascular lung water). 4. reduces organ dysfunction (assessed by the SOFA score), ICU stay and 7 and 28 day mortality Control group is managed with an algorithm using filling pressures to drive haemodynamic treatment.

Condition or disease Intervention/treatment Phase
Septic Shock Drug: FLUID MANAGEMENT GUIDED WITH PRELOAD-DEPENDENCE PARAMETERS (VOLUVEN ®) Drug: STANDARD-GUIDED FLUID MANAGEMENT (VOLUVEN ®) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 61 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effect of Haemodynamic Optimization Using Preload Dependence Indexes and Pulmonary Thermodilution on Cardiovascular Failure Duration During Septic Shock: a Randomized Study
Study Start Date : July 2007
Actual Primary Completion Date : August 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Shock
Drug Information available for: Hextend

Arm Intervention/treatment
Experimental: PRELOAD DEPENDENCE
in this arm, fluid loading is administered with an algorithm using preload dependence indexes (variation in cardiac output in response to passive leg raising).
Drug: FLUID MANAGEMENT GUIDED WITH PRELOAD-DEPENDENCE PARAMETERS (VOLUVEN ®)
in this arm, fluid loading is administered with an algorithm using preload dependence indexes. This algorithm is used every hour during the first 6 hours after inclusion, then every 4 hours until vasopressor weaning, and whenever mean arterial pressure fell below 65 mm Hg. Fluid loading is performed with cristalloids or colloids at the discretion of the attending physician.
Other Names:
  • Drug : ringer lactate, 0.9% saline, VOLUVEN ®
  • Procedure: haemodynamic algorithm (see below)

Active Comparator: CONTROL Drug: STANDARD-GUIDED FLUID MANAGEMENT (VOLUVEN ®)
in this arm, fluid loading is administered with an algorithm using central venous pressure. This algorithm is used every hour during the first 6 hours after inclusion, then every 4 hours until vasopressor weaning, and whenever mean arterial pressure fell below 65 mm Hg. Fluid loading is performed with cristalloids or colloids at the discretion of the attending physician.
Other Names:
  • Drug : ringer lactate, 0.9% saline, VOLUVEN ®
  • Procedure: haemodynamic algorithm (see below)




Primary Outcome Measures :
  1. Time to septic shock resolution [ Time Frame: 28 days ]
    shock resolution is defined by vasopressor weaning


Secondary Outcome Measures :
  1. mortality [ Time Frame: 28 days ]
  2. Ventilator free days [ Time Frame: 28 days ]
  3. number of days with hyperlactactatemia [ Time Frame: 28 days ]
  4. number of days with pulmonary edema [ Time Frame: 28 jours ]
    assessed by transpulmonary thermodilution



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • age over 18 years
  • and fulfilment of two of four criteria for the systemic inflammatory response syndrome
  • and systolic blood pressure no higher than 90 mm Hg (after a crystalloid-fluid challenge of 25 ml per kilogram of body weight over a 30-minute period)
  • and documented or suspected infection

Exclusion Criteria:

  • delay between first observation of hypotension and inclusion above 12 hours
  • pregnancy
  • acute coronary syndrome
  • acute cerebral vascular event (< 1 month),
  • contraindication to central venous catheterization in the superior vena cava territory
  • contraindication to femoral arterial catheterization
  • active haemorrhage
  • burn injury
  • trauma
  • requirement for immediate surgery (< 6 hours)
  • acute pulmonary oedema of cardiogenic origin
  • do-not-resuscitate status, or advanced directives restricting implementation of the protocol.
  • Informed consent not obtained from the patient or surrogates
  • Patient already included in another therapeutic trial
  • patient previously included in the same therapeutic trial

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Hospices Civils de Lyon
ClinicalTrials.gov Identifier: NCT01972828     History of Changes
Other Study ID Numbers: 2006.440
First Posted: October 31, 2013    Key Record Dates
Last Update Posted: October 31, 2013
Last Verified: October 2013

Keywords provided by Hospices Civils de Lyon:
Septic shock
Randomized controlled trial
Preload dependence
Pulmonary thermodilution

Additional relevant MeSH terms:
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Shock
Shock, Septic
Pathologic Processes
Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Hydroxyethyl Starch Derivatives
Plasma Substitutes
Blood Substitutes