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Cerebral Autoregulation in Non Neurological Critical Patients.

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2017 by Rafael Fernandez, Althaia Xarxa Assistencial Universitària de Manresa
Information provided by (Responsible Party):
Rafael Fernandez, Althaia Xarxa Assistencial Universitària de Manresa Identifier:
First received: November 13, 2012
Last updated: January 24, 2017
Last verified: January 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.

Anticipate results:

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.

Critical Illness
Complication of Ventilation Therapy
Systemic Inflammatory Response Syndrome
Failed Moderate Sedation During Procedure, Sequela

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Cerebral Autoregulation in Non Neurological Critical Patients.

Further study details as provided by Rafael Fernandez, Althaia Xarxa Assistencial Universitària de Manresa:

Primary Outcome Measures:
  • To describe the incidence of impairment of cerebral autoregulation in critically ill patients. [ Time Frame: 7 days ]

Secondary Outcome Measures:
  • 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 ]

Other Outcome Measures:
  • To describe the survival of patients who have impairment of cerebral autoregulation [ Time Frame: 3 months ]

Biospecimen Retention:   Samples Without DNA
Blood sample for biomarkers at admision, 72 hours and 7 days.

Estimated Enrollment: 100
Study Start Date: June 2012
Estimated Study Completion Date: March 2018
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
  Show Detailed Description


Ages Eligible for Study:   18 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients admited on the ICU that need mechanical ventialtion

Inclusion Criteria:

  • Patients older than 18 years old of age.
  • Patients under mechanical ventilation and/or sedation drugs and/or severe sepsis as defined on international criteria.
  • Patients with arterial line.

Exclusion Criteria:

  • Acute neurological pathology.
  • Absence of arterial line.
  • Severe haemodynamic instability defined as Mean Arterial Pressure (MAP) lower than 70 mmHg even with pressors.
  • Absence of temporal bone window for doing TCD.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01731106

Contact: Carles Subira, MD +34938759300 ext 3728

Carles Subira Cuyas Recruiting
Manresa, Barcelona, Spain, 08243
Contact: Carles Subira, MD    +34938759300 ext 3728   
Principal Investigator: Carles Subira, MD         
Sponsors and Collaborators
Althaia Xarxa Assistencial Universitària de Manresa
Study Director: Rafael Fernandez, Ph, MD Head of Department
  More Information

Responsible Party: Rafael Fernandez, Physician Doctor, Althaia Xarxa Assistencial Universitària de Manresa Identifier: NCT01731106     History of Changes
Other Study ID Numbers: Fundacio Unio CEIC 12/18
Study First Received: November 13, 2012
Last Updated: January 24, 2017

Additional relevant MeSH terms:
Critical Illness
Systemic Inflammatory Response Syndrome
Disease Attributes
Pathologic Processes
Shock processed this record on May 25, 2017