Trans Cranial Doppler Ultrasonography in Heamodynamic Optimisation in Septic Shock
Conditions
Keywords
Trans cranial doppler ultrasonography, hemodynamics, septic shock, sepsis associated encephalopathy
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.
Interventions
PROCEDUREhemodynamic optimisation aiming to achieve normal cerebral perfusion
hemodynamic optimisation aiming to achieve normal cerebral perfusion: titration of catecholamin infusion.
Sponsors
Mongi Slim Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| mortality at day 28 | 28 days after ICU admission | Mortality at day 28 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Tunisia
Contacts
Primary ContactMhamed Sami Mebazaa, professor
Backup ContactAsma Ben Souissi, Ass Prof
Outcome results
None listed