Skip to main content
Clinical Trials/NCT01972828
NCT01972828
Completed
Not Applicable

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

Hospices Civils de Lyon0 sites61 target enrollmentJuly 2007

Overview

Phase
Not Applicable
Intervention
FLUID MANAGEMENT GUIDED WITH PRELOAD-DEPENDENCE PARAMETERS (VOLUVEN ®)
Conditions
Septic Shock
Sponsor
Hospices Civils de Lyon
Enrollment
61
Primary Endpoint
Time to septic shock resolution
Status
Completed
Last Updated
12 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
July 2007
End Date
August 2013
Last Updated
12 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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
  • requirement for immediate surgery (\< 6 hours)
  • acute pulmonary oedema of cardiogenic origin

Arms & Interventions

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).

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

CONTROL

Intervention: STANDARD-GUIDED FLUID MANAGEMENT (VOLUVEN ®)

Outcomes

Primary Outcomes

Time to septic shock resolution

Time Frame: 28 days

shock resolution is defined by vasopressor weaning

Secondary Outcomes

  • mortality(28 days)
  • number of days with hyperlactactatemia(28 days)
  • Ventilator free days(28 days)
  • number of days with pulmonary edema(28 jours)

Similar Trials