Impact of an Echographic Algorithm on Hemodynamic Optimization in the First 4 Days of Septic Shock Management

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

136 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-02-08

Study Completion Date

2024-10-26

Brief Summary

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Fluid management is one of the key issues in the initial management of septic shock (SS). Fluid overload and hypovolemia have been associated with increased mortality in several trials. Transthoracic echocardiography (TTE) and lung ultrasound are recommended for haemodynamic assessment in critically ill patients. However, the benefit of hemodynamic optimisation using echography has not been yet evaluated. The purpose of this multicenter, controlled, randomized trial is to assess the impact of an echocardiographic algorithm of hemodynamic optimization on fluid management in septic patients during the first 4 days of therapy.

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Detailed Description

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Conditions

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Shock, Septic Hemodynamic Instability

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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Interventional Strategy: STOPFLUID Algorithm

Fluid management is optimised using the specific echographic hemodynamic algorithm ('STOPFLUID') of this study described during the first 4 days of septic shock. Fluid bolus will not be administered in case of increased left ventricle filling pressures; fluid challenge will be performed based on dynamic indices and fluid depletion will be considered on the basis of Lung UltraSound (LUS) assessment.

Group Type EXPERIMENTAL

Echographic hemodynamic algorithm guiding fluid resuscitation

Intervention Type OTHER

Ultrasound Hemodynamic Algorithm (UHA):

1. st step: 1/ Assessment of left ventricular filling pressures by Mitral Doppler echocardiography (2) 2/ Pulmonary ultrasound on 4 anterior dials (3)

E/Ea \>14 and/or E/A \>2
* YES =\> No filling test =\> Bilateral anterior B lines on lung ultrasound =\> YES =\> Consider administration of diuretics
* NO =\> Step 2
2. nd step: Assessment of filling response by dynamic maneuvers VTI (Velocity Time Integral) increase \>15% after passive leg raising (4) or Mini-fluid challenge (5,6) Or decision of a 250ml filling test

* YES =\> consider 250ml bolus filling
* NO =\> stop vascular filling
3. rd step if dynamic maneuvers in favor of a response to filling: 1/ Assessment of response to 250ml filling 2/ If no response to vascular filling: Pulmonary ultrasound on 4 anterior dials (3) Change from a pulmonary profile A to a pulmonary profile B

* YES =\> depletion
* NO =\> stop vascular filling

Standard Strategy

Fluid management will be handled according to standard care, without using transthoracic echocardiography (TTE) during the first 4 days of septic shock management. Haemodynamic monitoring including pulmonary artery catheter, transpulmonary thermodilution, or any other device will be left at the physician's discretion. TTE will be allowed in the standard group only for excluding cardiac tamponade in case of clinical suspicion (one or more of the following signs: jugular distension, pulsus paradoxus)

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Echographic hemodynamic algorithm guiding fluid resuscitation

Ultrasound Hemodynamic Algorithm (UHA):

1. st step: 1/ Assessment of left ventricular filling pressures by Mitral Doppler echocardiography (2) 2/ Pulmonary ultrasound on 4 anterior dials (3)

E/Ea \>14 and/or E/A \>2
* YES =\> No filling test =\> Bilateral anterior B lines on lung ultrasound =\> YES =\> Consider administration of diuretics
* NO =\> Step 2
2. nd step: Assessment of filling response by dynamic maneuvers VTI (Velocity Time Integral) increase \>15% after passive leg raising (4) or Mini-fluid challenge (5,6) Or decision of a 250ml filling test

* YES =\> consider 250ml bolus filling
* NO =\> stop vascular filling
3. rd step if dynamic maneuvers in favor of a response to filling: 1/ Assessment of response to 250ml filling 2/ If no response to vascular filling: Pulmonary ultrasound on 4 anterior dials (3) Change from a pulmonary profile A to a pulmonary profile B

* YES =\> depletion
* NO =\> stop vascular filling

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Patient in an intensive care unit who develops septic shock on admission or during hospitalization, as defined by SEPSIS-3 criteria.
* Patient or trusted person / legal representative / family member / curator / guardian who has given free and informed consent and has signed the consent form or patient included in an emergency situation.
* Patient affiliated or beneficiary of a health insurance plan.
* Patient at least (≥) 18 years of age.

Exclusion Criteria

* Refusal of consent.
* Patient under court protection or guardianship.
* Moribund patient with a life expectancy of less than 48 hours.
* Non-echogenic patient.
* Cardiac tamponade.
* Infective endocarditis.
* Intracavitary thrombus.
* Dilated cardiomyopathy with LVEF (Left Ventricular Ejection Fraction\<40%.
* Parturient or nursing patient.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No