Hemodynamic Optimisation Guided With Transcranial Doppler in Septic Shock

Mongi Slim Hospital

Status: Unknown

Conditions: Trans Cranial Doppler Ultrasonography in Heamodynamic Optimisation in Septic Shock

Treatments: Procedure: hemodynamic optimisation aiming to achieve normal cerebral perfusion

Study type: Interventional

Funder types: Other

Identifiers

NCT04398069

Hemodynamic optimization ICU

Details and patient eligibility

About

Randomized, controlled, prospective trial, including ICU patients with Sepsis or septic Shock, at the early phase.

patients will be randomized in 2 groups regarding the hemodynamic management and catecholamin doses:

• Group 1: standard hemodynamic goals and catecholamin infusion to achieve: mean arterial pressure > or equal to 65 mmHg and diastolic arterial pressure > ou equal to 50 mmHg within the first 60 minutes.
• Group 2: personalized hemodynamic goals and catecholamin infusion until normal transcranial doppler: IP<1,2.

Full description

Randomized, controlled, prospective trial, including ICU patients with Sepsis or septic Shock, at the early phase.

patients will be randomized in 2 groups regarding the hemodynamic management and catecholamin doses:

• Group 1: standard hemodynamic goals and cathecolamin infusion to achieve: mean arterial pressure > or equal to 65 mmHg and diastolic arterial pressure > ou equal to 50 mmHg within the first 60 minutes.
• Group 2: personalized hemodynamic goals and cathecolamin infusion until normal transcranial doppler: IP<1,2.

For the 2 groups, standard management including: microbiological sampling, early broad spectrum anti infective therapy, fluid management and decreasing of blood lactate levels, will be aimed within the first 60 minutes.

For the Group 2 patients: personalized hemodynamic management will be maintained during 72 hours.

Enrollment: 24 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• All ICU patients presenting septic shock
• No criteria of traumatic or vascular brain injury

Exclusion criteria

• Patients with refractory septick shock
• rapid fatal evolution: before 72 hours
• No individualisation of the MCA ultrasonographic window

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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24 participants in 2 patient groups

Standard Group

No Intervention group

Description:

standard hemodynamic goals and catecholamin infusion to achieve: mean arterial pressure \> or equal to 65 mmHg and diastolic arterial pressure \> ou equal to 50 mmHg within the first 60 minutes.

personalized hemodynamic goals Group

Experimental group

Description:

Personalized hemodynamic goals and catecholamin infusion to achieve normal cerebral perfusion assessed by transcranial doppler: PI \< 1,2.

Treatment:

Procedure: hemodynamic optimisation aiming to achieve normal cerebral perfusion