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Cerebral Hemodynamics and Oxygenation in Critically Ill Patients

C

Centre Hospitalier Universitaire de Nice

Status

Begins enrollment this month

Conditions

Septic Shock

Treatments

Procedure: mechanical ventilation
Drug: Sedation

Study type

Observational

Funder types

Other

Identifiers

NCT04690530
20reamed02

Details and patient eligibility

About

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.

Enrollment

60 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

60 participants in 1 patient group

patients admitted in medical intensive care unit who require mechanical ventilation and sedation
Description:
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.
Treatment:
Drug: Sedation
Procedure: mechanical ventilation

Trial contacts and locations

1

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Central trial contact

Jean Dellamonica; Mathieu Jozwiak

Data sourced from clinicaltrials.gov

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