Hemodynamic Optimisation Guided With Transcranial Doppler in Septic Shock

Trans Cranial Doppler Ultrasonography in Heamodynamic Optimisation in Septic Shock Clinical Trial

Official title:

Hemodynamic Optimisation Guided With Transcranial Doppler in Septic Shock

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04398069
• Other study ID #: Hemodynamic optimization ICU
• Status: Recruiting
• Phase: N/A
• Start date: January 2, 2020
• Est. completion date: October 30, 2020

Study information

• Verified date: May 2020
• Source: Mongi Slim Hospital
• Contact: Mhamed Sami Mebazaa, professor
• Phone: 0021622252589
• Email: msmebazaa[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 24
• Est. completion date: October 30, 2020
• Est. primary completion date: August 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Shock
• Shock, Septic
• Trans Cranial Doppler Ultrasonography in Heamodynamic Optimisation in Septic Shock

Intervention

Procedure:
• hemodynamic optimisation aiming to achieve normal cerebral perfusion
hemodynamic optimisation aiming to achieve normal cerebral perfusion: titration of catecholamin infusion.

Locations

Country	Name	City	State
Tunisia	Mongi Slim Hospital	Tunis

Sponsors (1)

Lead Sponsor	Collaborator
Mongi Slim Hospital

Country where clinical trial is conducted

Tunisia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	mortality at day 28	Mortality at day 28	28 days after ICU admission
Secondary	Incidence of sepsis associated encephalopathy	sepsis associated encephalopathy assessed by CAM-ICU and GCS scores	28 days after ICU admission
Secondary	Incidence of sepsis related organ failures	sepsis related organ failures assessed with SOFA score	28 days after ICU admission
Secondary	Length of ICU stay	Length of ICU stay	30 days after end of randomization