Hemodynamic Optimisation Guided With Transcranial Doppler in Septic Shock
NCT ID: NCT04398069
Last Updated: 2020-05-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
24 participants
INTERVENTIONAL
2020-01-02
2020-10-30
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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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.
No interventions assigned to this group
personalized hemodynamic goals Group
Personalized hemodynamic goals and catecholamin infusion to achieve normal cerebral perfusion assessed by transcranial doppler: PI \< 1,2.
hemodynamic optimisation aiming to achieve normal cerebral perfusion
hemodynamic optimisation aiming to achieve normal cerebral perfusion: titration of catecholamin infusion.
Interventions
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hemodynamic optimisation aiming to achieve normal cerebral perfusion
hemodynamic optimisation aiming to achieve normal cerebral perfusion: titration of catecholamin infusion.
Eligibility Criteria
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Inclusion Criteria
* No criteria of traumatic or vascular brain injury
Exclusion Criteria
* rapid fatal evolution: before 72 hours
* No individualisation of the MCA ultrasonographic window
18 Years
ALL
No
Sponsors
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Mongi Slim Hospital
OTHER
Responsible Party
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Mhamed Sami Mebazaa
Professor head of the anesthesia and intensive care department
Principal Investigators
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Mhamed Sami Mebazaa, Professor
Role: PRINCIPAL_INVESTIGATOR
Mongi Slim Hospital
Locations
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Mongi Slim Hospital
Tunis, , Tunisia
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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Hemodynamic optimization ICU
Identifier Type: -
Identifier Source: org_study_id
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