Skip to main content
Clinical Trials/NCT04398069
NCT04398069
Unknown
Not Applicable

Hemodynamic Optimisation Guided With Transcranial Doppler in Septic Shock

Mongi Slim Hospital1 site in 1 country24 target enrollmentJanuary 2, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Trans Cranial Doppler Ultrasonography in Heamodynamic Optimisation in Septic Shock
Sponsor
Mongi Slim Hospital
Enrollment
24
Locations
1
Primary Endpoint
mortality at day 28
Last Updated
5 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 2, 2020
End Date
October 30, 2020
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Mhamed Sami Mebazaa

Professor head of the anesthesia and intensive care department

Mongi Slim Hospital

Eligibility Criteria

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

Outcomes

Primary Outcomes

mortality at day 28

Time Frame: 28 days after ICU admission

Mortality at day 28

Secondary Outcomes

  • Incidence of sepsis associated encephalopathy(28 days after ICU admission)
  • Incidence of sepsis related organ failures(28 days after ICU admission)
  • Length of ICU stay(30 days after end of randomization)

Study Sites (1)

Loading locations...

Similar Trials