Cerebral Hemodynamics and Oxygenation in Critically Ill Patients

Cerebal Hemodynamics and Oxygenation in Critically Ill Patients : Characterization and Effects of Therapeutics

Critically-ill patients frequently experience marked changes in mean arterial pressure and carbon dioxide partial arterial pressure, the two major determinants of the cerebral blood flow. In addition, many therapeutics (fluids, vasopressors or inotropes administration, blood transfusion, prone positioning...) can influence these two determinants of cerebral blood flow and thus cerebral blood flow, especially in patients with altered cerebral autoregulation. Nevertheless, cerebral hemodynamics and oxygenation, as well as the effects of the different therapeutics on it have been poorly studied in critically-ill patients. In addition, it has been suggested that impaired cerebral blood flow and impaired cerebral microcirculation may be involved in the pathophysiology of septic encephalopathy in patients with sepsis and/or septic shock. In this study, we aimed to characterize and investigate the effects of different therapeutics on cerebral hemodynamics and oxygenation in critically-ill patients.

Study Overview

• Status: Not yet recruiting
• Conditions: Septic Shock
• Intervention / Treatment: Procedure: mechanical ventilation; Drug: Sedation

• Study Type: Observational
• Enrollment (Anticipated): 60

Contacts and Locations

• Study Contact: Name: Mathieu Jozwiak; Phone Number: +33158412661; Email: mathieu.jozwiak@aphp.fr
• Study Contact Backup: Name: Jean Dellamonica; Phone Number: +33492035510; Email: dellamonica.j@chu-nice.fr

Study Locations

• France
  • Nice, France, 06003
    • Chu de Nice
    • Contact: Jean Dellamonica; Phone Number: +33492035510; Email: dellamonica.j@chu-nice.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All consecutive patients admitted in our Medical Intensive Care Unit requiring mechanical ventilation and sedation and in whom the attending physician decides to perform one of the studied therapeutics within the first 72h of ventilation onset. Cerebral hemodynamics (cerebral blood flow and cerebral autoregulation) as well as cerebral oxygenation will be non-invasively studied before and after therapeutics.

Description

Inclusion Criteria :

• Patients under mechanical ventilation and sedated within the first 72h of ventilation onset
• Indication to one of the studied therapeutics left at the discretion of the attending physician Exclusion criteria
• Age < 18 years
• Pregnancy
• Inability to obtain a Doppler signal
• Medical history or clinical evidence of neurological disease
• Known severe carotid stenosis (>70%)
• Significant cardiac arrhythmias
• Care-limitation decision.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

patients admitted in medical intensive care unit who require mechanical ventilation and sedation; The main goals of the study are to characterize cerebral hemodynamics and oxygenation as well as to study the effects of therapeutics on it in critically-ill patients. For this purpose, we plan to include all consecutive patients admitted in our medical intensive care unit who require mechanical ventilation and sedation and in whom the attending physician decides to perform one of the studied therapeutics (fluids, vasopressors or inotropes administration, blood transfusion, prone positioning, passive leg raising test, end-expiratory occlusion test) within the first 72h of ventilation onset. Cerebral hemodynamics (cerebral blood flow and cerebral autoregulation) as well as cerebral oxygenation will be non-invasively studied before and after therapeutics.

Procedure: mechanical ventilation; mechanical vantilation will be performed; Drug: Sedation; sedation wil be performed

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cerebral blood flow	Use of transcranial Doppler	Within the first 72 hours of ventilation onset, before and after therapeutics

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cerebral autoregulation	Use of transcranial Doppler	Within the first 72 hours of ventilation onset, before and after therapeutics

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cerebral oxygenation	Use of non-invasive near-infrared spectroscopy (NIRS)	Within the first 72 hours of ventilation onset, before and after therapeutics

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nice

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): March 1, 2022
• Primary Completion (ANTICIPATED): March 1, 2022
• Study Completion (ANTICIPATED): March 1, 2022

Study Registration Dates

• First Submitted: December 18, 2020
• First Submitted That Met QC Criteria: December 29, 2020
• First Posted (ACTUAL): December 30, 2020

Study Record Updates

• Last Update Posted (ACTUAL): February 11, 2022
• Last Update Submitted That Met QC Criteria: February 10, 2022
• Last Verified: February 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Disease Attributes; Shock; Sepsis; Shock, Septic; Critical Illness
• Other Study ID Numbers: 20reamed02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: no data sharing plan is planned

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No