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

Centre Hospitalier Universitaire de Nīmes

Status: Enrolling

Conditions: Hemodynamic Instability; Shock, Septic

Treatments: Other: Echographic hemodynamic algorithm guiding fluid resuscitation

Study type: Interventional

Funder types: Other

Identifiers

NCT06043505

2023-A00111-44

Details and patient eligibility

About

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.

Enrollment: 136 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

All eligible patients will have a cardiac echocardiogram prior to inclusion for the sole purpose of eliminating special situations that are part of the non-inclusion criteria listed below.

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.

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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136 participants in 2 patient groups

Interventional Strategy: STOPFLUID Algorithm

Experimental group

Description:

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.

Treatment:

Other: Echographic hemodynamic algorithm guiding fluid resuscitation

Standard Strategy

No Intervention group

Description:

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)