Septic ShockNCT05833607
Effects of Targets of Blood Pressure on Cerebral Hemodynamics in Septic Shock
An observational study of Septic Shock and Cerebral Autoregulation, run by D'Or Institute for Research and Education at 1 site in Brazil.
Trial summary
The sudy objective is to evaluate the cerebral haemodynamic status in different ranges of systemic arterial pressure in patients with septic shock by noninvasive tools, transcranial doppler and intracranial compliance by mechanical sensor (B4C). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Septic Shock, Cerebral Autoregulation
- How many people
- 40 participants
- Where
- 1 siteBrazil
- Study dates
- 7 Jul 2022to 7 Jul 2024
- Phase
- Observational
- 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
Study population: Patients with septic shock with less than 48 hours of ICU stay
Who may be able to join
- < 48 hours in the intensive care unit
- Septic shock (sepsis 3.0)
Who cannot join
- No window for DTC
- Hepatic or uremic encephalopathy
- Pregnancy
- Acute or prior structural neurological insult
- Exogenous intoxication
- Dementia
Show all 10Show fewer
- Chronic Obstructive Pulmonary Disease
- Instability for acute arrhythmia
- Extracorporeal support by modifying the pulse wave form (intra aortic balloon pump and Extracorporeal membrane oxygenation
- Extreme severity, with imminent risk of death
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
São Rafael Hospital
Salvador, Estado de Bahia, 41253-190
Juliana Caldas, +55 71 99901-9500, caldas.juliana@gmail.com
Pedro Cury, +55 71 991950585, pedrovcury@gmail.com
About this study
Official title: Effects of Systemic Blood Pressure Targets on Cerebral Hemodynamics in Septic Shock: a Prospective Study
The sudy objective is to evaluate the cerebral haemodynamic status in different ranges of systemic arterial pressure in patients with septic shock by noninvasive tools, transcranial doppler and intracranial compliance by mechanical sensor (B4C).
Patients participating in the study will be submitted to different levels of arterial pressure, titrated with vasopressor and them their cerebral hemodynamic variables will be evaluated,
Read the detailed description
Sepsis is the most prevalent cause of admissions to the intensive care unit (ICU) and many of these patients develop septic shock (SC) (need for vasoactive drug, after adequate fluid administration, plus hyperlactatemia). The SC involvement is systemic, so the investigators started to monitor organ dysfunctions and their perfusion windows, including neurological disorders, when is affected, in addition to indicating severity, are also a predictor of worse prognosis.
The principle of cerebral autoregulation (CA) is the basic defense mechanism against pressure oscillations in the most diverse contexts. The SC is a state of vasodilation and consequent drop in mean arterial pressure (MAP), that under normal physiological conditions would be compensated by CA. But it is not known exactly how CA performance at this profile of patients.
The investigators will assess cerebral hemodynamics in SC patients at different MAP targets, in order to identify whether this regulatory variable would be able to generate better parameters of cerebral hemodynamics.
Some smaller studies have shown that liver and heart dysfunction correlate with worsening autoregulation. Another clinical trial showed an inverse relationship between CA and the Sequential Organ Failure Assessment, in addition to the loss of CA in patients with circulatory shock in general. Post-mortem data found generalized ischemic lesions in the brain of septic patients, which translates into a state of reduction at vascular flow. This patient profile has more blood-brain barrier dysfunction, but further studies are needed to correlate CA and CS.
The study will be carried out in the ICU of Hospital São Rafael (HSR), located in the city of Salvador-Ba, Brazil. For the evaluation of cerebral hemodynamics Transcranial Doppler and a Mechanical sensor (B4C) will be used.
Data collection on admission will include the following: demographic characteristics, comorbidities, source of infection, Sequential Organ Failure Assessment (SOFA) at ICU admission, temperature, Glasgow Coma scale (GCE) or Richmond Agitation Sedation Scale (RASS), mechanical ventilation, arterial blood gasses before and after the protocol.
All patients will be monitored with an arterial line, cardioscopy, pulse oximetry and capnography (if unavailable at the time of collection, this will be described). Before starting the monitoring, the proper functioning of the arterial circuit will be confirmed and a blood gas analysis will be collected, as well as at the end.
The investigators will collet data with the patient's baseline pressure for 5 minutes (T0), then through the titration of vasopressors, for another 5 minutes each mean arterial pressure target at 65mmHg (T1), 75 mmHg (T2) and 85 mmHg (T3). After collection, the baseline mean arterial pressure will be restored
- Conditions
- Septic Shock, Cerebral Autoregulation
- Keywords
- Septic Shock, Cerebral autoregulation, Cerebral hemodynamics
- Medical subject headings
- Shock, Septic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| ALL PATIENTS | All patients are monitored with the transcranial Doppler helmet and the 2Hz probe in one of the middle cerebral hemispheres and the Brain 4 care on the other side. Necessary monitoring: arterial line, electrocardiographic monitor, pulse oximetry, temperature. ETCO2 monitoring whenever possible. Step 1: Test arterial line circuit, ensure proper temperature, arterial blood gases Step 2: Record data with the patient's baseline pressure (data from the monitor, transcranial doppler and brain4care), for 5 min Step 3: Vasopressor titrant for 3 MAP targets (65, 75 and 85 mmHg) , record data with the patient's baseline pressure (data from the monitor, transcranial doppler and brain4care), each target record for 3 minutes Step 4: Arterial blood gases, gradually restore PAM to baseline value |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary objective is to evaluate the effects of cerebral haemodynamic in patients with septic shock in different targets of MAP, through ARI (by Transcranial Doppler), and intracranial compliance by mechanical sensor (B4C)
This outcome will be analyzed by transcranial Doppler (ARI, PI) and B4C (intracranial compliance) index). Data will be obtained at the time of collection (mean arterial pressure targets) and subsequently analyzed
Measured: Data will be obtained at the time of collection (mean arterial pressure targets) and subsequently analyzed
Secondary outcomes (4)
Assess factors that influence cerebral autoregulation (by ARI) and intracranial compliance (B4C)
To verify clinical factors that influence cerebral autoregulation (CA) and intracranial compliance of septic patients
Measured: Data will be obtained at the time of collection (mean arterial pressure targets) and subsequently analyzed
Evaluate the correlation between CA by TDC and B4C index.
Report the similarity between the two indices
Measured: Data will be obtained at the time of collection (mean arterial pressure targets) and subsequently analyzed
Correlate mechanical ventilation time with perfusion pressure value
Observation that there is a correlation between the duration of mechanical ventilation and the patient's baseline perfusion pressure
Measured: Mechanical ventilation time up to 28 days
Explore the correlation between incidence of brain dysfunction
Brain dysfunction will be considered as: Glasgow Coma Scale score < 15 or when disorientation, altered thinking or agitation was reported by the attending physician, independently of the use of sedatives/analgesics and in the absence of previous neurological diseases (i.e., dementia, cerebrovascular disease, brain tumors, previous traumatic brain injury) with DTC and B4C index.
Measured: Until 28º day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2023
- Study start7 Jul 2022
- Primary completion30 Dec 2023 (estimated)
- Study completion7 Jul 2024 (estimated)
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 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- D'Or Institute for Research and Education
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Juliana Caldas, Phd, Principal investigator, D'Or Institute for Research and Education (IDOR), Hospital São RafaelPedro Cury, Study chair, D'Or Institute for Research and Education (IDOR), Hospital São Rafael
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05833607
- Sponsor's protocol ID
- 28134720.1.0000.0048
- Status last verified
- Apr 2023
- First submitted
- 29 Mar 2023
- Last updated
- 27 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: We don't have that plan, but if the data is useful for larger research, no problem.
Publications
Cury P, Passos RDH, Alves F, Brasil S, Frigieri G, Taccone FS, Panerai RB, Caldas J. Impact of different blood pressure targets on cerebral hemodynamics in septic shock: A prospective pilot study protocol-SEPSIS-BRAIN. PLoS One. 2024 Oct 14;19(10):e0304412. doi: 10.1371/journal.pone.0304412. eCollection 2024.
PubMed 39401208
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Systemic Blood Pressure Targets on Cerebral Hemodynamics in Septic Shock: a Prospective Study
- ClinicalTrials.gov ID
- NCT05833607
- Acronym / sponsor ID
- 28134720.1.0000.0048
- Conditions
- Septic Shock, Cerebral Autoregulation
- Keywords
- Septic Shock, Cerebral autoregulation, Cerebral hemodynamics
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- D'Or Institute for Research and EducationUniversity, hospital or other
- Study start
- 7 Jul 2022 (actual)
- Primary completion
- 30 Dec 2023 (estimated)
- Study completion
- 7 Jul 2024 (estimated)
- First posted
- 27 Apr 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 sudy objective is to evaluate the cerebral haemodynamic status in different ranges of systemic arterial pressure in patients with septic shock by noninvasive tools, transcranial doppler and intracranial compliance by mechanical sensor (B4C).
Patients participating in the study will be submitted to different levels of arterial pressure, titrated with vasopressor and them their cerebral hemodynamic variables will be evaluated,
Detailed description
Sepsis is the most prevalent cause of admissions to the intensive care unit (ICU) and many of these patients develop septic shock (SC) (need for vasoactive drug, after adequate fluid administration, plus hyperlactatemia). The SC involvement is systemic, so the investigators started to monitor organ dysfunctions and their perfusion windows, including neurological disorders, when is affected, in addition to indicating severity, are also a predictor of worse prognosis.
The principle of cerebral autoregulation (CA) is the basic defense mechanism against pressure oscillations in the most diverse contexts. The SC is a state of vasodilation and consequent drop in mean arterial pressure (MAP), that under normal physiological conditions would be compensated by CA. But it is not known exactly how CA performance at this profile of patients.
The investigators will assess cerebral hemodynamics in SC patients at different MAP targets, in order to identify whether this regulatory variable would be able to generate better parameters of cerebral hemodynamics.
Some smaller studies have shown that liver and heart dysfunction correlate with worsening autoregulation. Another clinical trial showed an inverse relationship between CA and the Sequential Organ Failure Assessment, in addition to the loss of CA in patients with circulatory shock in general. Post-mortem data found generalized ischemic lesions in the brain of septic patients, which translates into a state of reduction at vascular flow. This patient profile has more blood-brain barrier dysfunction, but further studies are needed to correlate CA and CS.
The study will be carried out in the ICU of Hospital São Rafael (HSR), located in the city of Salvador-Ba, Brazil. For the evaluation of cerebral hemodynamics Transcranial Doppler and a Mechanical sensor (B4C) will be used.
Data collection on admission will include the following: demographic characteristics, comorbidities, source of infection, Sequential Organ Failure Assessment (SOFA) at ICU admission, temperature, Glasgow Coma scale (GCE) or Richmond Agitation Sedation Scale (RASS), mechanical ventilation, arterial blood gasses before and after the protocol.
All patients will be monitored with an arterial line, cardioscopy, pulse oximetry and capnography (if unavailable at the time of collection, this will be described). Before starting the monitoring, the proper functioning of the arterial circuit will be confirmed and a blood gas analysis will be collected, as well as at the end.
The investigators will collet data with the patient's baseline pressure for 5 minutes (T0), then through the titration of vasopressors, for another 5 minutes each mean arterial pressure target at 65mmHg (T1), 75 mmHg (T2) and 85 mmHg (T3). After collection, the baseline mean arterial pressure will be restored
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ALL PATIENTS | – | –All patients are monitored with the transcranial Doppler helmet and the 2Hz probe in one of the middle cerebral hemispheres and the Brain 4 care on the other side. Necessary monitoring: arterial line, electrocardiographic monitor, pulse oximetry, temperature. ETCO2 monitoring whenever possible. Step 1: Test arterial line circuit, ensure proper temperature, arterial blood gases Step 2: Record data with the patient's baseline pressure (data from the monitor, transcranial doppler and brain4care), for 5 min Step 3: Vasopressor titrant for 3 MAP targets (65, 75 and 85 mmHg) , record data with the patient's baseline pressure (data from the monitor, transcranial doppler and brain4care), each target record for 3 minutes Step 4: Arterial blood gases, gradually restore PAM to baseline value |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with septic shock with less than 48 hours of ICU stay
Key inclusion criteria (2 listed)
- < 48 hours in the intensive care unit
- Septic shock (sepsis 3.0)
Key exclusion criteria (10 listed)
- No window for DTC
- Hepatic or uremic encephalopathy
- Pregnancy
- Acute or prior structural neurological insult
- Exogenous intoxication
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The primary objective is to evaluate the effects of cerebral haemodynamic in patients with septic shock in different targets of MAP, through ARI (by Transcranial Doppler), and intracranial compliance by mechanical sensor (B4C)
Time frame: Data will be obtained at the time of collection (mean arterial pressure targets) and subsequently analyzed
This outcome will be analyzed by transcranial Doppler (ARI, PI) and B4C (intracranial compliance) index). Data will be obtained at the time of collection (mean arterial pressure targets) and subsequently analyzed
4 secondary outcomes
Assess factors that influence cerebral autoregulation (by ARI) and intracranial compliance (B4C)
Time frame: Data will be obtained at the time of collection (mean arterial pressure targets) and subsequently analyzed
Evaluate the correlation between CA by TDC and B4C index.
Time frame: Data will be obtained at the time of collection (mean arterial pressure targets) and subsequently analyzed
Correlate mechanical ventilation time with perfusion pressure value
Time frame: Mechanical ventilation time up to 28 days
Explore the correlation between incidence of brain dysfunction
Time frame: Until 28º day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Apr 2023.
- Derived from this study: PubMed 39401208Cury P, Passos RDH, Alves F, Brasil S, Frigieri G, Taccone FS, Panerai RB, Caldas J. Impact of different blood pressure targets on cerebral hemodynamics in septic shock: A prospective pilot study protocol-SEPSIS-BRAIN. PLoS One. 2024 Oct 14;19(10):e0304412. doi: 10.1371/journal.pone.0304412. eCollection 2024.
- The Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3)Link provided by the sponsor.
- Surviving sepsis campaign: international guidelines for management of sepsis and septic shock 2021Link provided by the sponsor.
- Cerebral dysfunctions caused by sepsis during ageingLink provided by the sponsor.
- Cerebral autoregulationLink provided by the sponsor.
- Dynamic Autoregulation is Impaired in Circulatory ShockLink provided by the sponsor.
- Impaired cerebral autoregulation is associated with brain dysfunction in patients with sepsisLink provided by the sponsor.
- Individual participant dataSharing planned: No. We don't have that plan, but if the data is useful for larger research, no problem.
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Sepsis
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.
Juliana Caldas, Phd principal investigator
D'Or Institute for Research and Education (IDOR), Hospital São Rafael
Pedro Cury study chair
D'Or Institute for Research and Education (IDOR), Hospital São Rafael
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Septic Shock and Cerebral Autoregulation, run by D'Or Institute for Research and Education at 1 site in Brazil.
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 10 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 27 Apr 2023. 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 Brazil. 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 Pedro Cury (+5571991950585, pedrovcury@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary objective is to evaluate the effects of cerebral haemodynamic in patients with septic shock in different targets of MAP, through ARI (by Transcranial Doppler), and intracranial compliance by mechanical sensor (B4C) (time frame: Data will be obtained at the time of collection (mean arterial pressure targets) and subsequently analyzed). 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 NCT05833607, 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 27 Apr 2023.