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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:
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard Group | No Intervention | 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. | |
| personalized hemodynamic goals Group | Experimental | Personalized hemodynamic goals and catecholamin infusion to achieve normal cerebral perfusion assessed by transcranial doppler: PI < 1,2. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| hemodynamic optimisation aiming to achieve normal cerebral perfusion | Procedure | hemodynamic optimisation aiming to achieve normal cerebral perfusion: titration of catecholamin infusion. |
| Measure | Description | Time Frame |
|---|---|---|
| mortality at day 28 | Mortality at day 28 | 28 days after ICU admission |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mhamed Sami Mebazaa, professor | Contact | 0021622252589 | msmebazaa@gmail.com | |
| Asma Ben Souissi, Ass Prof | Contact | 0021698336883 | bsouissiasma@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Mhamed Sami Mebazaa, Professor | Mongi Slim Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mongi Slim Hospital | Recruiting | Tunis | 2046 | Tunisia |
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| ID | Term |
|---|---|
| D012772 | Shock, Septic |
| D065166 | Sepsis-Associated Encephalopathy |
| ID | Term |
|---|---|
| D018805 | Sepsis |
| D007239 | Infections |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
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| 28 days after ICU admission |
| Length of ICU stay | Length of ICU stay | 30 days after end of randomization |
| D010335 |
| Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012769 | Shock |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |