Hemodynamic Optimisation Guided With Transcranial Doppler in Septic Shock

Not Applicable

• Conditions: Trans Cranial Doppler Ultrasonography in Heamodynamic Optimisation in Septic Shock
• Interventions: Procedure: hemodynamic optimisation aiming to achieve normal cerebral perfusion

• Registration Number: NCT04398069
• Lead Sponsor: Mongi Slim Hospital

Brief Summary

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

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.

Study Timeline

• Study Start: 2020-01-02
• Status Verified: 2020-05
• Study First Submitted: 2020-05-18
• Study First Submitted QC: 2020-05-18
• Last Update Submitted: 2020-05-18
• Study First Posted: 2020-05-21
• Last Update Posted: 2020-05-21
• Primary Completion: 2020-08-31
• Study Completion: 2020-10-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 24

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
personalized hemodynamic goals Group	hemodynamic optimisation aiming to achieve normal cerebral perfusion	Personalized hemodynamic goals and catecholamin infusion to achieve normal cerebral perfusion assessed by transcranial doppler: PI \< 1,2.

Primary Outcome Measures

Name	Time	Method
mortality at day 28	28 days after ICU admission	Mortality at day 28

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Mongi Slim Hospital; 🇹🇳 Tunis, Tunisia