Back to resultsHemodynamic Optimisation Guided With Transcranial Doppler in Septic Shock
Primary Purpose
Trans Cranial Doppler Ultrasonography in Heamodynamic Optimisation in Septic Shock
Status
Unknown status
Phase
Not Applicable
Locations
Tunisia
Study Type
Interventional
Intervention
hemodynamic optimisation aiming to achieve normal cerebral perfusion
Sponsored by
About this trial
This is an interventional supportive care trial for Trans Cranial Doppler Ultrasonography in Heamodynamic Optimisation in Septic Shock focused on measuring Trans cranial doppler ultrasonography, hemodynamics, septic shock, sepsis associated encephalopathy
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
Sites / Locations
- Mongi Slim HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Standard Group
personalized hemodynamic goals Group
Arm Description
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 and catecholamin infusion to achieve normal cerebral perfusion assessed by transcranial doppler: PI < 1,2.
Outcomes
Primary Outcome Measures
mortality at day 28
Mortality at day 28
Secondary Outcome Measures
Incidence of sepsis associated encephalopathy
sepsis associated encephalopathy assessed by CAM-ICU and GCS scores
Incidence of sepsis related organ failures
sepsis related organ failures assessed with SOFA score
Length of ICU stay
Length of ICU stay
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04398069
Brief Title
Hemodynamic Optimisation Guided With Transcranial Doppler in Septic Shock
Official Title
Hemodynamic Optimisation Guided With Transcranial Doppler in Septic Shock
Study Type
Interventional
2. Study Status
Record Verification Date
May 2020
Overall Recruitment Status
Unknown status
Study Start Date
January 2, 2020 (Actual)
Primary Completion Date
August 31, 2020 (Anticipated)
Study Completion Date
October 30, 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mongi Slim Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Trans Cranial Doppler Ultrasonography in Heamodynamic Optimisation in Septic Shock
Keywords
Trans cranial doppler ultrasonography, hemodynamics, septic shock, sepsis associated encephalopathy
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
24 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Standard Group
Arm Type
No Intervention
Arm Description
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.
Arm Title
personalized hemodynamic goals Group
Arm Type
Experimental
Arm Description
Personalized hemodynamic goals and catecholamin infusion to achieve normal cerebral perfusion assessed by transcranial doppler: PI < 1,2.
Intervention Type
Procedure
Intervention Name(s)
hemodynamic optimisation aiming to achieve normal cerebral perfusion
Intervention Description
hemodynamic optimisation aiming to achieve normal cerebral perfusion: titration of catecholamin infusion.
Primary Outcome Measure Information:
Title
mortality at day 28
Description
Mortality at day 28
Time Frame
28 days after ICU admission
Secondary Outcome Measure Information:
Title
Incidence of sepsis associated encephalopathy
Description
sepsis associated encephalopathy assessed by CAM-ICU and GCS scores
Time Frame
28 days after ICU admission
Title
Incidence of sepsis related organ failures
Description
sepsis related organ failures assessed with SOFA score
Time Frame
28 days after ICU admission
Title
Length of ICU stay
Description
Length of ICU stay
Time Frame
30 days after end of randomization
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mhamed Sami Mebazaa, professor
Phone
0021622252589
Email
msmebazaa@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Asma Ben Souissi, Ass Prof
Phone
0021698336883
Email
bsouissiasma@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mhamed Sami Mebazaa, Professor
Organizational Affiliation
Mongi Slim Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mongi Slim Hospital
City
Tunis
ZIP/Postal Code
2046
Country
Tunisia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mhamed Sami Mebazaa, professor
Phone
0021622252589
Email
msmebazaa@gmail.com
First Name & Middle Initial & Last Name & Degree
Asma Ben Souissi, Ass Prof
Phone
0021698336883
Email
bsouissiasma@gmail.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Hemodynamic Optimisation Guided With Transcranial Doppler in Septic Shock
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