Hemodynamic Optimisation Guided With Transcranial Doppler in Septic Shock

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Hemodynamic Optimisation Guided With Transcranial Doppler in Septic Shock

Conditions
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Trans Cranial Doppler Ultrasonography in Heamodynamic Optimisation in Septic Shock

Intervention / Treatment
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* Procedure: hemodynamic optimisation aiming to achieve normal cerebral perfusion


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Standard Group<br>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. | |
| Experimental: personalized hemodynamic goals Group<br>Personalized hemodynamic goals and catecholamin infusion to achieve normal cerebral perfusion assessed by transcranial doppler: PI < 1,2. | Procedure: hemodynamic optimisation aiming to achieve normal cerebral perfusion<br>* hemodynamic optimisation aiming to achieve normal cerebral perfusion: titration of catecholamin infusion.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mortality at day 28 | Mortality at day 28 | 28 days after ICU admission | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of sepsis associated encephalopathy | sepsis associated encephalopathy assessed by CAM-ICU and GCS scores | 28 days after ICU admission | 
| Incidence of sepsis related organ failures | sepsis related organ failures assessed with SOFA score | 28 days after ICU admission | 
| Length of ICU stay | Length of ICU stay | 30 days after end of randomization | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Trans cranial doppler ultrasonography, hemodynamics, septic shock, sepsis associated encephalopathy