Hemodynamic Optimisation Guided With Transcranial Doppler in Septic Shock

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.

Study Overview

• Status: Unknown
• Conditions: Trans Cranial Doppler Ultrasonography in Heamodynamic Optimisation in Septic Shock
• Intervention / Treatment: Procedure: hemodynamic optimisation aiming to achieve normal cerebral perfusion

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 Type: Interventional
• Enrollment (Anticipated): 24
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Asma Ben Souissi, Ass Prof; Phone Number: 0021698336883; Email: bsouissiasma@gmail.com

Study Locations

• Tunisia
  • Tunis, Tunisia, 2046
    • Recruiting
    • Mongi Slim hospital
    • Contact: Asma Ben Souissi, Ass Prof; Phone Number: 0021698336883; Email: bsouissiasma@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Standard Group; 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; 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; hemodynamic optimisation aiming to achieve normal cerebral perfusion: titration of catecholamin infusion.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Mongi Slim Hospital
• Investigators: Principal Investigator: Mhamed Sami Mebazaa, Professor, Mongi Slim hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 2, 2020
• Primary Completion (Anticipated): August 31, 2020
• Study Completion (Anticipated): October 30, 2020

Study Registration Dates

• First Submitted: May 18, 2020
• First Submitted That Met QC Criteria: May 18, 2020
• First Posted (Actual): May 21, 2020

Study Record Updates

• Last Update Posted (Actual): May 21, 2020
• Last Update Submitted That Met QC Criteria: May 18, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Keywords: Trans cranial doppler ultrasonography, hemodynamics, septic shock, sepsis associated encephalopathy
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Sepsis; Shock, Septic; Shock
• Other Study ID Numbers: Hemodynamic optimization ICU

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No