Trans Cranial Doppler Ultrasonography in Heamodynamic Optimisation in Septic ShockNCT04398069
Hemodynamic Optimisation Guided With Transcranial Doppler in Septic Shock
A study testing hemodynamic optimisation aiming to achieve normal cerebral perfusion in people with Trans Cranial Doppler Ultrasonography in Heamodynamic Optimisation in Septic Shock, run by Mongi Slim Hospital at 1 site in Tunisia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Trans Cranial Doppler Ultrasonography in Heamodynamic Optimisation in Septic Shock
- What is being tested?
- hemodynamic optimisation aiming to achieve normal cerebral perfusion
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteTunisia
- Study dates
- 2 Jan 2020to 30 Oct 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All ICU patients presenting septic shock
- No criteria of traumatic or vascular brain injury
Who cannot join
- Patients with refractory septick shock
- rapid fatal evolution: before 72 hours
- No individualisation of the MCA ultrasonographic window
Trial locations and contacts
1 site in 1 country.
Tunisia1 site, 1 recruiting
- Recruiting
Mongi Slim Hospital
Tunis, 2046
Mhamed Sami Mebazaa, professor, 0021622252589, msmebazaa@gmail.com
Asma Ben Souissi, Ass Prof, 0021698336883, bsouissiasma@gmail.com
About this study
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.
Read the 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.
- Being tested
- hemodynamic optimisation aiming to achieve normal cerebral perfusion
- Keywords
- Trans cranial doppler ultrasonography, hemodynamics, septic shock, sepsis associated encephalopathy
- Medical subject headings
- Shock, Septic, Sepsis-Associated Encephalopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hemodynamic optimisation aiming to achieve normal cerebral perfusionProcedure or surgery
hemodynamic optimisation aiming to achieve normal cerebral perfusion: titration of catecholamin infusion.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: hemodynamic optimisation aiming to achieve normal cerebral perfusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
mortality at day 28
Mortality at day 28
Measured: 28 days after ICU admission
Secondary outcomes (3)
Incidence of sepsis associated encephalopathy
sepsis associated encephalopathy assessed by CAM-ICU and GCS scores
Measured: 28 days after ICU admission
Incidence of sepsis related organ failures
sepsis related organ failures assessed with SOFA score
Measured: 28 days after ICU admission
Length of ICU stay
Length of ICU stay
Measured: 30 days after end of randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2020
- Study start2 Jan 2020
- Primary completion31 Aug 2020 (estimated)
- Study completion30 Oct 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Trans Cranial Doppler Ultrasonography in Heamodynamic Optimisation in Septic ShockStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mongi Slim Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mhamed Sami Mebazaa, Mongi Slim Hospital
- Investigators
- Mhamed Sami Mebazaa, Professor, Principal investigator, Mongi Slim Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04398069
- Sponsor's protocol ID
- Hemodynamic optimization ICU
- Status last verified
- May 2020
- First submitted
- 18 May 2020
- Last updated
- 21 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hemodynamic Optimisation Guided With Transcranial Doppler in Septic Shock
- ClinicalTrials.gov ID
- NCT04398069
- Acronym / sponsor ID
- Hemodynamic optimization ICU
- Keywords
- Trans cranial doppler ultrasonography, hemodynamics, septic shock, sepsis associated encephalopathy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Mongi Slim HospitalUniversity, hospital or other
- Study start
- 2 Jan 2020 (actual)
- Primary completion
- 31 Aug 2020 (estimated)
- Study completion
- 30 Oct 2020 (estimated)
- First posted
- 21 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 | Procedure: hemodynamic optimisation aiming to achieve normal cerebral perfusionPersonalized hemodynamic goals and catecholamin infusion to achieve normal cerebral perfusion assessed by transcranial doppler: PI < 1,2. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- All ICU patients presenting septic shock
- No criteria of traumatic or vascular brain injury
Key exclusion criteria (3 listed)
- Patients with refractory septick shock
- rapid fatal evolution: before 72 hours
- No individualisation of the MCA ultrasonographic window
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| hemodynamic optimisation aiming to achieve normal cerebral perfusionhemodynamic optimisation aiming to achieve normal cerebral perfusion: titration of catecholamin infusion. | Procedure or surgery | personalized hemodynamic goals Group |
Primary outcome
mortality at day 28
Time frame: 28 days after ICU admission
Mortality at day 28
3 secondary outcomes
Incidence of sepsis associated encephalopathy
Time frame: 28 days after ICU admission
Incidence of sepsis related organ failures
Time frame: 28 days after ICU admission
Length of ICU stay
Time frame: 30 days after end of randomization
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2020.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mhamed Sami Mebazaa, Professor principal investigator
Mongi Slim Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing hemodynamic optimisation aiming to achieve normal cerebral perfusion in people with Trans Cranial Doppler Ultrasonography in Heamodynamic Optimisation in Septic Shock, run by Mongi Slim Hospital at 1 site in Tunisia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Tunisia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mhamed Sami Mebazaa, professor (0021622252589, msmebazaa@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
mortality at day 28 (time frame: 28 days after ICU admission). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2020.