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

NCT01972828 | Completed

• 1 other identifier: 2006.440
• Study Type: interventional
• Target: 61
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Septic Shock

Keywords

Septic shock; Randomized controlled trial; Preload dependence; Pulmonary thermodilution

Outcome Measures

Primary Outcomes (1)

• Time to septic shock resolution

  shock resolution is defined by vasopressor weaning

  28 days

Secondary Outcomes (4)

• mortality

  28 days

• Ventilator free days

  28 days

• number of days with hyperlactactatemia

  28 days

• number of days with pulmonary edema

  28 jours

Study Arms (2)

PRELOAD DEPENDENCE

EXPERIMENTAL

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 ®)

CONTROL

ACTIVE COMPARATOR

Drug: STANDARD-GUIDED FLUID MANAGEMENT (VOLUVEN ®)

Interventions

FLUID MANAGEMENT GUIDED WITH PRELOAD-DEPENDENCE PARAMETERS (VOLUVEN ®) DRUG

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.

Also known as: Drug : ringer lactate, 0.9% saline, VOLUVEN ®, Procedure: haemodynamic algorithm (see below)

PRELOAD DEPENDENCE

STANDARD-GUIDED FLUID MANAGEMENT (VOLUVEN ®) DRUG

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.

Also known as: Drug : ringer lactate, 0.9% saline, VOLUVEN ®, Procedure: haemodynamic algorithm (see below)

CONTROL

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Related Publications (1)

• Richard JC, Bayle F, Bourdin G, Leray V, Debord S, Delannoy B, Stoian AC, Wallet F, Yonis H, Guerin C. Preload dependence indices to titrate volume expansion during septic shock: a randomized controlled trial. Crit Care. 2015 Jan 8;19(1):5. doi: 10.1186/s13054-014-0734-3.

  PMID: 25572383 DERIVED

MeSH Terms

Conditions

Shock, Septic

Interventions

HES 130-0.4; Sodium Chloride

Condition Hierarchy (Ancestors)

Sepsis; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Intervention Hierarchy (Ancestors)

Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 11, 2013
• First Posted: October 31, 2013
• Study Start: July 1, 2007
• Primary Completion: August 1, 2013
• Last Updated: October 31, 2013

Record last verified: 2013-10