Hemodynamic Optimisation Guided With Transcranial Doppler in Septic Shock

NCT ID: NCT04398069

Last Updated: 2020-05-21

Study Results

Results pending

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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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-02

Study Completion Date

2020-10-30

Brief Summary

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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:

* 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

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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:

* 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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Trans Cranial Doppler Ultrasonography in Heamodynamic Optimisation in Septic Shock

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

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.

Group Type NO_INTERVENTION

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.

Group Type EXPERIMENTAL

hemodynamic optimisation aiming to achieve normal cerebral perfusion

Intervention Type PROCEDURE

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.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mongi Slim Hospital

OTHER

Sponsor Role lead

Responsible Party

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Mhamed Sami Mebazaa

Professor head of the anesthesia and intensive care department

Responsibility Role PRINCIPAL_INVESTIGATOR

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

Site Status RECRUITING

Countries

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Tunisia

Central Contacts

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Mhamed Sami Mebazaa, professor

Role: CONTACT

0021622252589

Asma Ben Souissi, Ass Prof

Role: CONTACT

0021698336883

Facility Contacts

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Mhamed Sami Mebazaa, professor

Role: primary

0021622252589

Asma Ben Souissi, Ass Prof

Role: backup

0021698336883

Other Identifiers

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Hemodynamic optimization ICU

Identifier Type: -

Identifier Source: org_study_id

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