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

NCT ID: NCT01972828

Last Updated: 2013-10-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 61 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-07-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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).

Group Type: EXPERIMENTAL

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

Intervention Type: 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.

CONTROL

Group Type: ACTIVE_COMPARATOR

STANDARD-GUIDED FLUID MANAGEMENT (VOLUVEN ®)

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Other Intervention Names

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

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
• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospices Civils de Lyon

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

References

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.

Reference Type: DERIVED

PMID: 25572383 (View on PubMed)

Other Identifiers

2006.440

Identifier Type: -

Identifier Source: org_study_id