Cerebral Hemodynamics and Oxygenation in Critically Ill Patients

NCT04690530 | Not Yet Recruiting

• 1 other identifier: 20reamed02
• Study Type: observational
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Septic Shock

Outcome Measures

Primary Outcomes (1)

• Cerebral blood flow

  Use of transcranial Doppler

  Within the first 72 hours of ventilation onset, before and after therapeutics

Secondary Outcomes (1)

• Cerebral autoregulation

  Within the first 72 hours of ventilation onset, before and after therapeutics

Other Outcomes (1)

• Cerebral oxygenation

  Within the first 72 hours of ventilation onset, before and after therapeutics

Study Arms (1)

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; Drug: Sedation

Interventions

mechanical ventilation PROCEDURE

mechanical vantilation will be performed

patients admitted in medical intensive care unit who require mechanical ventilation and sedation

Sedation DRUG

sedation wil be performed

patients admitted in medical intensive care unit who require mechanical ventilation and sedation

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

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.

You may qualify if:

• Patients under mechanical ventilation and sedated within the first 72h of ventilation onset

You may not qualify if:

• 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.

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Nice: lead

Study Sites (1)

CHU de NICE

Nice, 06003, France

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

whole blood

MeSH Terms

Conditions

Shock, Septic

Interventions

Respiration, Artificial

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Airway Management; Therapeutics; Resuscitation; Emergency Treatment; Respiratory Therapy

Central Study Contacts

Mathieu Jozwiak

CONTACT

+33158412661; mathieu.jozwiak@aphp.fr

Jean Dellamonica

CONTACT

+33492035510; dellamonica.j@chu-nice.fr

Study Design

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

Study Record Dates

• First Submitted: December 18, 2020
• First Posted: December 30, 2020
• Study Start: March 1, 2026
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: April 10, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)