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

Septic Shock Clinical Trial

— EHOSS-1  

Official title:

Effect of Haemodynamic Optimization Using Preload Dependence Indexes and Pulmonary Thermodilution on Cardiovascular Failure Duration During Septic Shock: a Randomized Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01972828
• Other study ID #: 2006.440
• Status: Completed
• Phase: N/A
• First received: October 11, 2013
• Last updated: October 30, 2013
• Start date: July 2007

Study information

• Verified date: October 2013
• Source: Hospices Civils de Lyon
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Direction Générale de la Santé
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 61
• Est. primary completion date: August 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Septic Shock
• Shock
• Shock, Septic

Intervention

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.
• 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hospices Civils de Lyon

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to septic shock resolution	shock resolution is defined by vasopressor weaning	28 days	No
Secondary	mortality		28 days	No
Secondary	Ventilator free days		28 days	No
Secondary	number of days with hyperlactactatemia		28 days	No
Secondary	number of days with pulmonary edema	assessed by transpulmonary thermodilution	28 jours	No