Cerebral Autoregulation in Non Neurological Critical Patients.

NCT01731106 | Terminated DMC

• 1 other identifier: Fundacio Unio CEIC 12/18
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• To describe the incidence of impairment of cerebral autoregulation in critically ill patients.

  7 days

Secondary Outcomes (2)

• To describe the incidence of delirium in critically ill patients with or without impairment of cerebral autoregulation

  30 days

• To describe the long term cognitive impariment in critically ill patients.

  3, 6 and 12 months

Other Outcomes (1)

• To describe the survival of patients who have impairment of cerebral autoregulation

  3 months

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients admited on the ICU that need mechanical ventialtion

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Althaia Xarxa Assistencial Universitària de Manresa: lead

Study Sites (1)

Carles Subira Cuyas

Manresa, Barcelona, 08243, Spain

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood sample for biomarkers at admision, 72 hours and 7 days.

MeSH Terms

Conditions

Critical Illness; Systemic Inflammatory Response Syndrome

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Inflammation; Shock

Study Officials

• Rafael Fernandez, Ph, MD

  Head of Department

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physician Doctor

Study Record Dates

• First Submitted: November 13, 2012
• First Posted: November 21, 2012
• Study Start: June 1, 2012
• Primary Completion: December 1, 2017
• Study Completion: March 1, 2018
• Last Updated: June 27, 2018

Record last verified: 2018-06

Locations

ES (1)