- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04690530
Cerebral Hemodynamics and Oxygenation in Critically Ill Patients
February 10, 2022 updated by: Centre Hospitalier Universitaire de Nice
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
Intervention / Treatment
Study Type
Observational
Enrollment (Anticipated)
60
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
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
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-
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Nice, France, 06003
- Chu de Nice
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Contact:
- Jean Dellamonica
- Phone Number: +33492035510
- Email: dellamonica.j@chu-nice.fr
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
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
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
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.
|
mechanical vantilation will be performed
sedation wil be performed
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cerebral blood flow
Time Frame: Within the first 72 hours of ventilation onset, before and after therapeutics
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Use of transcranial Doppler
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Within the first 72 hours of ventilation onset, before and after therapeutics
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Cerebral autoregulation
Time Frame: Within the first 72 hours of ventilation onset, before and after therapeutics
|
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
Time Frame: Within the first 72 hours of ventilation onset, before and after therapeutics
|
Use of non-invasive near-infrared spectroscopy (NIRS)
|
Within the first 72 hours of ventilation onset, before and after therapeutics
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
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
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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