Cerebral Hemodynamics and Oxygenation in Critically Ill Patients

NCT ID: NCT04690530

Last Updated: 2025-04-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2026-03-01

Study Completion Date

2027-03-01

Brief Summary

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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

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Conditions

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Septic Shock

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

mechanical ventilation

Intervention Type PROCEDURE

mechanical vantilation will be performed

Sedation

Intervention Type DRUG

sedation wil be performed

Interventions

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mechanical ventilation

mechanical vantilation will be performed

Intervention Type PROCEDURE

Sedation

sedation wil be performed

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire de Nice

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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CHU de NICE

Nice, , France

Site Status

Countries

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France

Central Contacts

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Mathieu Jozwiak

Role: CONTACT

+33158412661

Jean Dellamonica

Role: CONTACT

+33492035510

Facility Contacts

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Jean Dellamonica

Role: primary

+33492035510

Other Identifiers

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20reamed02

Identifier Type: -

Identifier Source: org_study_id

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