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

Not Applicable

Completed

• Conditions: Septic Shock
• Interventions: Drug: FLUID MANAGEMENT GUIDED WITH PRELOAD-DEPENDENCE PARAMETERS (VOLUVEN ®); Drug: STANDARD-GUIDED FLUID MANAGEMENT (VOLUVEN ®)

• Registration Number: NCT01972828
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-07
• Primary Completion: 2013-08
• Status Verified: 2013-10
• Study First Submitted: 2013-10-11
• Study First Submitted QC: 2013-10-30
• Last Update Submitted: 2013-10-30
• Study First Posted: 2013-10-31
• Last Update Posted: 2013-10-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 61

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PRELOAD DEPENDENCE	FLUID MANAGEMENT GUIDED WITH PRELOAD-DEPENDENCE PARAMETERS (VOLUVEN ®)	in this arm, fluid loading is administered with an algorithm using preload dependence indexes (variation in cardiac output in response to passive leg raising).
CONTROL	STANDARD-GUIDED FLUID MANAGEMENT (VOLUVEN ®)	-

Primary Outcome Measures

Name	Time	Method
Time to septic shock resolution	28 days	shock resolution is defined by vasopressor weaning

Secondary Outcome Measures

Name	Time	Method
mortality	28 days
number of days with hyperlactactatemia	28 days
Ventilator free days	28 days
number of days with pulmonary edema	28 jours	assessed by transpulmonary thermodilution