Effects of Targets of Blood Pressure on Cerebral Hemodynamics in Septic Shock

NCT05833607 | Unknown DMC

• 1 other identifier: 28134720.1.0000.0048
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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). 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,

Conditions

Septic Shock; Cerebral Autoregulation

Keywords

Septic Shock; Cerebral autoregulation; Cerebral hemodynamics

Outcome Measures

Primary Outcomes (1)

• 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

  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)

  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.

  Data will be obtained at the time of collection (mean arterial pressure targets) and subsequently analyzed

• Correlate mechanical ventilation time with perfusion pressure value

  Mechanical ventilation time up to 28 days

• Explore the correlation between incidence of brain dysfunction

  Until 28º day

Study Arms (1)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with septic shock with less than 48 hours of ICU stay

You may qualify if:

• \< 48 hours in the intensive care unit
• Septic shock (sepsis 3.0)

You may not qualify if:

• No window for DTC
• Hepatic or uremic encephalopathy
• Pregnancy
• Acute or prior structural neurological insult
• Exogenous intoxication
• Dementia
• 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

Sponsors & Collaborators

• D'Or Institute for Research and Education: lead

Study Sites (1)

São Rafael Hospital

Salvador, Estado de Bahia, 41253-190, Brazil

RECRUITING

Related Publications (1)

• 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.

  PMID: 39401208 DERIVED

Related Links

• The Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3)
• Surviving sepsis campaign: international guidelines for management of sepsis and septic shock 2021
• Cerebral dysfunctions caused by sepsis during ageing
• Cerebral autoregulation
• Dynamic Autoregulation is Impaired in Circulatory Shock
• Impaired cerebral autoregulation is associated with brain dysfunction in patients with sepsis
• Waveform Morphology as a Surrogate for ICP Monitoring: A Comparison Between an Invasive and a Noninvasive Method
• Noninvasive intracranial pressure waveforms for estimation of intracranial hypertension and outcome prediction in acute brain-injured patients
• Persistent cognitive impairment, hippocampal atrophy and EEG changes in sepsis survivors
• POCUS, how can we include the brain? An overview
• A Novel Noninvasive Technique for Intracranial Pressure Waveform Monitoring in Critical Care
• Daily blood pressure variability in relation to neurological functional outcomes after acute ischemic stroke

MeSH Terms

Conditions

Shock, Septic

Condition Hierarchy (Ancestors)

Sepsis; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Study Officials

• Juliana Caldas, Phd

  D'Or Institute for Research and Education (IDOR), Hospital São Rafael

  PRINCIPAL INVESTIGATOR

• Pedro Cury

  D'Or Institute for Research and Education (IDOR), Hospital São Rafael

  STUDY CHAIR

Central Study Contacts

Pedro Cury

CONTACT

+5571991950585; pedrovcury@gmail.com

Juliana Caldas

CONTACT

+55 71 9901-9500; caldas.juliana@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 29, 2023
• First Posted: April 27, 2023
• Study Start: July 7, 2022
• Primary Completion: December 30, 2023
• Study Completion: July 7, 2024
• Last Updated: April 27, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

BR (1)