Cerebral Autoregulation in Non Neurological Critical Patients.
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.
Complication of Ventilation Therapy
Systemic Inflammatory Response Syndrome
Failed Moderate Sedation During Procedure, Sequela
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Cerebral Autoregulation in Non Neurological Critical Patients.|
- To describe the incidence of impairment of cerebral autoregulation in critically ill patients. [ Time Frame: 7 days ] [ Designated as safety issue: No ]
- To describe the incidence of delirium in critically ill patients with or without impairment of cerebral autoregulation [ Time Frame: 30 days ] [ Designated as safety issue: No ]
- To describe the long term cognitive impariment in critically ill patients. [ Time Frame: 3, 6 and 12 months ] [ Designated as safety issue: No ]
- To describe the survival of patients who have impairment of cerebral autoregulation [ Time Frame: 3 months ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples Without DNA
Blood sample for biomarkers at admision, 72 hours and 7 days.
|Study Start Date:||June 2012|
|Estimated Study Completion Date:||March 2016|
|Estimated Primary Completion Date:||December 2015 (Final data collection date for primary outcome measure)|
Please refer to this study by its ClinicalTrials.gov identifier: NCT01731106
|Contact: Subira CS Carles, Physician||+34938759300 ext email@example.com|
|Carles Subira Cuyas||Recruiting|
|Barcelona, Spain, 08006|
|Contact: Carles CS Subira, Physician +34938759300 ext 3216 firstname.lastname@example.org|
|Principal Investigator: Carles CS Subira, physician|
|Study Director:||Fernandez Rafael, PhMD||Chief|