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Completed

NCT Number: NCT01972828

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: Drug : ringer lactate, 0.9% saline, VOLUVEN ®, Procedure: haemodynamic algorithm (see below)

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.

Other names: Drug : ringer lactate, 0.9% saline, VOLUVEN ®, Procedure: haemodynamic algorithm (see below)

Primary outcomes

  1. Time to septic shock resolution

    Time frame: 28 days

    shock resolution is defined by vasopressor weaning

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Hospices Civils de Lyon

Other

Registry information

Official study title

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

Acronym: EHOSS-1

Important dates

Study start
2007
Primary completion
2013
First posted
Oct 31, 2013
Registry last updated
Oct 31, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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