Cerebral Hemodynamics and Oxygenation in Critically Ill Patients

Not yet recruiting

• Conditions: Septic Shock
• Interventions: Procedure: mechanical ventilation; Drug: Sedation

• Registration Number: NCT04690530
• Lead Sponsor: Centre Hospitalier Universitaire de Nice

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-12-18
• Study First Submitted QC: 2020-12-29
• Study First Posted: 2020-12-30
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-09
• Last Update Posted: 2025-04-10
• Study Start: 2026-03-01
• Primary Completion: 2027-03-01
• Study Completion: 2027-03-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
patients admitted in medical intensive care unit who require mechanical ventilation and sedation	mechanical ventilation	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.
patients admitted in medical intensive care unit who require mechanical ventilation and sedation	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.

Primary Outcome Measures

Name	Time	Method
Cerebral blood flow	Within the first 72 hours of ventilation onset, before and after therapeutics	Use of transcranial Doppler

Secondary Outcome Measures

Name	Time	Method
Cerebral autoregulation	Within the first 72 hours of ventilation onset, before and after therapeutics	Use of transcranial Doppler

Trial Locations

Locations (1)

CHU de NICE; 🇫🇷 Nice, France