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

Sponsor

Hospices Civils de Lyon (Other)

Overall Status

Completed

CT.gov ID

NCT01972828

Collaborator

(none)

Enrollment

Arms

Study Details

Study Description

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 ®)	N/A

Study Design

Study Type:

Interventional

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 :

Jul 1, 2007

Actual Primary Completion Date :

Aug 1, 2013

Arms and Interventions

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)

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)

Outcome Measures

Primary Outcome Measures

Time to septic shock resolution [28 days]
shock resolution is defined by vasopressor weaning

Secondary Outcome Measures

mortality [28 days]
Ventilator free days [28 days]
number of days with hyperlactactatemia [28 days]
number of days with pulmonary edema [28 jours]
assessed by transpulmonary thermodilution

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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