Cerebral Autoregulation in Non Neurological Critical Patients.
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|ClinicalTrials.gov Identifier: NCT01731106|
Recruitment Status : Recruiting
First Posted : November 21, 2012
Last Update Posted : January 25, 2017
Brief Summary Cerebral Autoregulation is a well known physiological response to blood pressure changes to maintain the cerebral perfusion. The critically ill patients are submitted to different situations that can impair the cerebral autoregulation as sepsis, sedation drugs and mechanical ventilation.
The delirium on ICU has been described as a bad prognosis factor, increasing the mortality and length of stay. The physiopathology of delirium has been related to cerebral perfusion. The delirium has been related to long term cognitive impairment.
Material and Methods:
This is a physiological prospective study that will be done in a 14 bed medical-surgical ICU. The investigators will enroll 100 ventilated patients, septic and non-septic. The investigators will measure cerebral autoregulation every 48-72 hours from admission on ICU. Neurological biomarkers (Neurological Specific Enolase, S100 beta and Vascular Endothelial Growing Factor) will be done at inclusion, 72 hours and 7 days. Clinical data, delirium presence, analytic data and ventilatory parameters will be registered every day.
At hospital discharge, a psychologist will do a cognitive evaluation using specific tests. The cognitive evaluation will be repeated at 3, 6 and 12 months.
Some items like mechanical ventilation, sepsis and sedation can impair cerebral autoregulation. The impairment of cerebral autoregulation is related to delirium in ICU and long cognitive impairment.
|Condition or disease|
|Critical Illness Complication of Ventilation Therapy Systemic Inflammatory Response Syndrome Failed Moderate Sedation During Procedure, Sequela|
Show Detailed Description
|Study Type :||Observational|
|Estimated Enrollment :||100 participants|
|Official Title:||Cerebral Autoregulation in Non Neurological Critical Patients.|
|Study Start Date :||June 2012|
|Estimated Primary Completion Date :||December 2017|
|Estimated Study Completion Date :||March 2018|
- To describe the incidence of impairment of cerebral autoregulation in critically ill patients. [ Time Frame: 7 days ]
- To describe the incidence of delirium in critically ill patients with or without impairment of cerebral autoregulation [ Time Frame: 30 days ]
- To describe the long term cognitive impariment in critically ill patients. [ Time Frame: 3, 6 and 12 months ]
- To describe the survival of patients who have impairment of cerebral autoregulation [ Time Frame: 3 months ]
Biospecimen Retention: Samples Without DNA
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01731106
|Contact: Carles Subira, MD||+34938759300 ext firstname.lastname@example.org|
|Carles Subira Cuyas||Recruiting|
|Manresa, Barcelona, Spain, 08243|
|Contact: Carles Subira, MD +34938759300 ext 3728 email@example.com|
|Principal Investigator: Carles Subira, MD|
|Study Director:||Rafael Fernandez, Ph, MD||Head of Department|