Cerebral Hemodynamics and Oxygenation in Critically Ill Patients

Septic Shock Clinical Trial

Official title:

Cerebal Hemodynamics and Oxygenation in Critically Ill Patients : Characterization and Effects of Therapeutics

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04690530
• Other study ID #: 20reamed02
• Status: Not yet recruiting
• Start date: March 1, 2022
• Est. completion date: March 1, 2022

Study information

• Verified date: February 2022
• Source: Centre Hospitalier Universitaire de Nice
• Contact: Mathieu Jozwiak
• Phone: +33158412661
• Email: mathieu.jozwiak[@]aphp.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 60
• Est. completion date: March 1, 2022
• Est. primary completion date: March 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Critical Illness
• Septic Shock
• Shock, Septic

Intervention

Procedure:
• mechanical ventilation
mechanical vantilation will be performed

Drug:
• Sedation
sedation wil be performed

Locations

Country	Name	City	State
France	CHU de NICE	Nice

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nice

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Cerebral oxygenation	Use of non-invasive near-infrared spectroscopy (NIRS)	Within the first 72 hours of ventilation onset, before and after therapeutics
Primary	Cerebral blood flow	Use of transcranial Doppler	Within the first 72 hours of ventilation onset, before and after therapeutics
Secondary	Cerebral autoregulation	Use of transcranial Doppler	Within the first 72 hours of ventilation onset, before and after therapeutics