Cerebral Hemodynamics and Oxygenation in Critically Ill Patients

Sponsor
Centre Hospitalier Universitaire de Nice (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04690530
Collaborator
(none)
60
1

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

Study Design

Study Type:
Observational
Anticipated Enrollment :
60 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Cerebal Hemodynamics and Oxygenation in Critically Ill Patients : Characterization and Effects of Therapeutics
Anticipated Study Start Date :
Mar 1, 2022
Anticipated Primary Completion Date :
Mar 1, 2022
Anticipated Study Completion Date :
Mar 1, 2022

Arms and Interventions

Arm 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

Outcome Measures

Primary Outcome Measures

  1. Cerebral blood flow [Within the first 72 hours of ventilation onset, before and after therapeutics]

    Use of transcranial Doppler

Secondary Outcome Measures

  1. Cerebral autoregulation [Within the first 72 hours of ventilation onset, before and after therapeutics]

    Use of transcranial Doppler

Other Outcome Measures

  1. Cerebral oxygenation [Within the first 72 hours of ventilation onset, before and after therapeutics]

    Use of non-invasive near-infrared spectroscopy (NIRS)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 CHU de NICE Nice France 06003

Sponsors and Collaborators

  • Centre Hospitalier Universitaire de Nice

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Centre Hospitalier Universitaire de Nice
ClinicalTrials.gov Identifier:
NCT04690530
Other Study ID Numbers:
  • 20reamed02
First Posted:
Dec 30, 2020
Last Update Posted:
Feb 11, 2022
Last Verified:
Feb 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Feb 11, 2022