Cerebral Autoregulation in Non Neurological Critical Patients.

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by Althaia Xarxa Assistencial Universitària de Manresa
Sponsor:
Information provided by (Responsible Party):
Rafael Fernandez, Althaia Xarxa Assistencial Universitària de Manresa
ClinicalTrials.gov Identifier:
NCT01731106
First received: November 13, 2012
Last updated: November 28, 2013
Last verified: November 2013
  Purpose

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.


Condition
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.

Resource links provided by NLM:


Further study details as provided by 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Other Outcome Measures:
  • 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.


Estimated Enrollment: 100
Study Start Date: June 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients admited on the ICU that need mechanical ventialtion

Criteria

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 ClinicalTrials.gov identifier: NCT01731106

Contacts
Contact: Subira CS Carles, Physician +34938759300 ext 3216 carlessubira@gmail.com

Locations
Spain
Carles Subira Cuyas Recruiting
Barcelona, Spain, 08006
Contact: Carles CS Subira, Physician    +34938759300 ext 3216    carlessubira@gmail.com   
Principal Investigator: Carles CS Subira, physician         
Sponsors and Collaborators
Althaia Xarxa Assistencial Universitària de Manresa
Investigators
Study Director: Fernandez Rafael, PhMD Chief
  More Information

No publications provided

Responsible Party: Rafael Fernandez, Physician Doctor, Althaia Xarxa Assistencial Universitària de Manresa
ClinicalTrials.gov Identifier: NCT01731106     History of Changes
Other Study ID Numbers: Fundacio Unio CEIC 12/18
Study First Received: November 13, 2012
Last Updated: November 28, 2013
Health Authority: Spain: Comité Ético de Investigación Clínica

Additional relevant MeSH terms:
Critical Illness
Systemic Inflammatory Response Syndrome
Disease Attributes
Pathologic Processes
Inflammation
Shock

ClinicalTrials.gov processed this record on September 18, 2014