SepsisNCT05842616
Cerebral Pulsatility Index Compared To Mean Arterial Blood Pressure Guided Protocol In Sepsis Induced Encephalopathy:
A study testing Transcranial doppler pulsatility index guided protocol and Mean arterial blood pressure guided protocol in people with Sepsis and Norepinephrine, run by Tanta University at 1 site in Egypt.
Trial summary
The aim of our study is to compare between transcranial doppler pulsatility index and mean arterial blood pressure in guiding management of sepsis induced encephalopathy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sepsis, Norepinephrine, Encephalopathy
- What is being tested?
- Transcranial doppler pulsatility index guided protocol and Mean arterial blood pressure guided protocol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 112 participants
- Where
- 1 siteEgypt
- Study dates
- 1 May 2023to 30 Jun 2024
- 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
- Patients aged 18 years or older
- Must had clinical diagnosis of sepsis induced encephalopathy.
Who cannot join
- Refusal to participate in the study.
- Cerebral infection.
- Known cerebral lesions (Neoplasm, Traumatic brain injury, Stroke, Ischemic or hemorrhagic cerebrovascular lesions, high intracranial pressure).
- Known severe carotid stenosis (>70％).
- Intoxication due to drugs.
- Pregnancy.
- Patients supported by intra-aortic balloon pumb (IABP).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Norepinephrine Titration In Patients With Sepsis Induced Encephalopathy: Cerebral Pulsatility Index Compared To Mean Arterial Blood Pressure Guided Protocol
The aim of our study is to compare between transcranial doppler pulsatility index and mean arterial blood pressure in guiding management of sepsis induced encephalopathy.
Read the detailed description
Sepsis induced encephalopathy is the most frequent sepsis related organ dysfunction. It appears early during the course of infection, often before any other organ involvement in up to 70% of hospitalized septic patients and is associated with significant change of cerebral circulation caused by redistribution of blood flow during sepsis that accompanies the abnormal inflammatory response during an infection, in absence of direct central nervous system involvement.
- Conditions
- Sepsis, Norepinephrine, Encephalopathy
- Being tested
- Transcranial doppler pulsatility index guided protocol, Mean arterial blood pressure guided protocol
- Medical subject headings
- Sepsis, Brain Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transcranial doppler pulsatility index guided protocolOther
Norepinephrine titration that will be guided by Transcranial doppler pulsatility index.
Mean arterial blood pressure guided protocolOther
Norepinephrine titration that will be guided by Mean arterial blood pressure (MAP).
| Study group | Role | What they receive |
|---|---|---|
| Transcranial doppler pulsatility index guided protocol | Experimental | Norepinephrine titration that will be guided by Transcranial doppler (TCD) pulsatility index. Receives: Other: Transcranial doppler pulsatility index guided protocol |
| Mean arterial blood pressure guided protocol | Active comparator | Norepinephrine titration that will be guided by Mean arterial blood pressure (MAP). Receives: Other: Mean arterial blood pressure guided protocol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intensive care unit (ICU) mortality
Incidence of Intensive care unit (ICU) stay will be recorded
Measured: 28 day or till death which earlier
Secondary outcomes (6)
Mean arterial pressure
Fluid resuscitation will be started using crystalloids at a rate of 4 to 6 ml/kg with reevaluation after 15 minutes.
If MAP is still less than 65 mmhg, fluid resuscitation should be continued at a rate of 4 to 6 ml/kg with reevaluation after another 15 minutes up to 30 ml/kg.
Vasopressors will be started if the patient is still hypotensive during or after resuscitation without delay even peripherally to avoid delay until central venous access is secured (norepinephrine is the first line agent preferred over other vasopressors).
Measured: 24 hours
Norepinephrine titration
Fluid resuscitation will be started using crystalloids at a rate of 4 to 6 ml/kg with reevaluation after 15 minutes.
If MAP is still less than 65 mmhg, fluid resuscitation should be continued at a rate of 4 to 6 ml/kg with reevaluation after another 15 minutes up to 30 ml/kg.
Vasopressors will be started if the patient is still hypotensive during or after resuscitation without delay even peripherally to avoid delay until central venous access is secured (norepinephrine is the first line agent preferred over other vasopressors).
Measured: 24 hours
Cerebral perfusion pressure
Cerebral perfusion pressure (CPP) will be done using transcranial doppler.
Measured: 24 hours
Outcome of encephalopathy
Encephalopathy outcome at ICU discharge using Glasgow coma scale (GCS)
Measured: 28 day
SOFA score
SOFA score at ICU admission and discharge.
Measured: Up to 4 weeks.
Length of ICU stay
Length of ICU stay
Measured: At least 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2023
- Study start1 May 2023
- Primary completion30 Jun 2024
- Study completion30 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SepsisStudies of the same condition, open and under way.
- More trials run by Tanta UniversityThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 112 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mai Salah Salem, Tanta University
- Investigators
- Mai S Aboshaara, MD, Principal investigator, Assistant lecturer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05842616
- Sponsor's protocol ID
- 35559/6/22
- Status last verified
- Aug 2024
- First submitted
- 15 Apr 2023
- Last updated
- 6 Aug 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Publications
Salem MS, Abosabaa MA, Abd El Ghafar MS, Ei-Gendy HMEM, Alsherif SEI. Norepinephrine titration in patients with sepsis-induced encephalopathy: cerebral pulsatility index compared to mean arterial pressure guided protocol: randomized controlled trial. BMC Anesthesiol. 2025 Jan 4;25(1):5. doi: 10.1186/s12871-024-02814-0.
PubMed 39755598
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Norepinephrine Titration In Patients With Sepsis Induced Encephalopathy: Cerebral Pulsatility Index Compared To Mean Arterial Blood Pressure Guided Protocol
- ClinicalTrials.gov ID
- NCT05842616
- Acronym / sponsor ID
- 35559/6/22
- Conditions
- Sepsis, Norepinephrine, Encephalopathy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 112 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 1 May 2023 (actual)
- Primary completion
- 30 Jun 2024 (actual)
- Study completion
- 30 Jun 2024 (actual)
- First posted
- 6 May 2023 (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.
The aim of our study is to compare between transcranial doppler pulsatility index and mean arterial blood pressure in guiding management of sepsis induced encephalopathy.
Detailed description
Sepsis induced encephalopathy is the most frequent sepsis related organ dysfunction. It appears early during the course of infection, often before any other organ involvement in up to 70% of hospitalized septic patients and is associated with significant change of cerebral circulation caused by redistribution of blood flow during sepsis that accompanies the abnormal inflammatory response during an infection, in absence of direct central nervous system involvement.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transcranial doppler pulsatility index guided protocol | Experimental | Other: Transcranial doppler pulsatility index guided protocolNorepinephrine titration that will be guided by Transcranial doppler (TCD) pulsatility index. |
| Mean arterial blood pressure guided protocol | Active comparator | Other: Mean arterial blood pressure guided protocolNorepinephrine titration that will be guided by Mean arterial blood pressure (MAP). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients aged 18 years or older
- Must had clinical diagnosis of sepsis induced encephalopathy.
Key exclusion criteria (7 listed)
- Refusal to participate in the study.
- Cerebral infection.
- Known cerebral lesions (Neoplasm, Traumatic brain injury, Stroke, Ischemic or hemorrhagic cerebrovascular lesions, high intracranial pressure).
- Known severe carotid stenosis (>70％).
- Intoxication due to drugs.
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 |
|---|---|---|
| Transcranial doppler pulsatility index guided protocolNorepinephrine titration that will be guided by Transcranial doppler pulsatility index. | Other | Transcranial doppler pulsatility index guided protocol |
| Mean arterial blood pressure guided protocolNorepinephrine titration that will be guided by Mean arterial blood pressure (MAP). | Other | Mean arterial blood pressure guided protocol |
Primary outcome
Intensive care unit (ICU) mortality
Time frame: 28 day or till death which earlier
Incidence of Intensive care unit (ICU) stay will be recorded
6 secondary outcomes
Mean arterial pressure
Time frame: 24 hours
Norepinephrine titration
Time frame: 24 hours
Cerebral perfusion pressure
Time frame: 24 hours
Outcome of encephalopathy
Time frame: 28 day
SOFA score
Time frame: Up to 4 weeks.
Length of ICU stay
Time frame: At least 28 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2024.
- Derived from this study: PubMed 39755598Salem MS, Abosabaa MA, Abd El Ghafar MS, Ei-Gendy HMEM, Alsherif SEI. Norepinephrine titration in patients with sepsis-induced encephalopathy: cerebral pulsatility index compared to mean arterial pressure guided protocol: randomized controlled trial. BMC Anesthesiol. 2025 Jan 4;25(1):5. doi: 10.1186/s12871-024-02814-0.
- Individual participant dataSharing planned: Yes. The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Related trials for Sepsis
Not yet recruitingPhase 2/3
A Pivotal Safety and Immunogenicity GBS-NN/NN2 Vaccine Maternal Immunisation Trial
Streptococcus Agalactiae Infection, Neonatal Sepsis
Active, not recruiting
CT for Personalized Mechanical Ventilation
Ventilator-Induced Lung Injury, Sepsis Syndrome
RecruitingPhase 4
A Study to Compare the Efficacy and Safety of Extended and Intermittent Infusion of Beta-lactams in Critically Ill Paediatric Patients
Infection, Sepsis
Not yet recruiting
Double Plasma Separation and Adsorption in Acute-on-Chronic Liver Failure (DPMAS-ACLF Trial)
Acute-on-Chronic Liver Failure (ACLF)
Active, not recruitingPhase 4
Thymosin Alpha 1 and IgM Levels in Sepsis
Sepsis, Septic Shock
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.
Mai S Aboshaara, MD principal investigator
Assistant lecturer
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transcranial doppler pulsatility index guided protocol and Mean arterial blood pressure guided protocol in people with Sepsis and Norepinephrine, run by Tanta University at 1 site in Egypt.
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 7 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: finished, as of the sponsor's last update on 6 Aug 2024. 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 Egypt. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intensive care unit (ICU) mortality (time frame: 28 day or till death which earlier). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05842616, which also lists 1 linked publication.
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 6 Aug 2024.