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Cerebral Oxygenation and Neurological Outcomes FOllowing CriticAL Illness-2 (CONFOCAL-2)

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ClinicalTrials.gov Identifier: NCT03141619
Recruitment Status : Recruiting
First Posted : May 5, 2017
Last Update Posted : March 20, 2019
Sponsor:
Collaborators:
University Health Network, Toronto
Vancouver General Hospital
University of Western Ontario, Canada
Information provided by (Responsible Party):
Dr. Gordon Boyd, Queen's University

Brief Summary:
This study is designed to test the hypothesis that poor cerebral perfusion during critical illness is a risk factor for acute and long-term neurological dysfunction among survivors. We use near-infrared spectroscopy to measure brain tissue oxygenation as a non-invasive surrogate marker for cerebral perfusion. Acute neurological dysfunction is defined as the presence of delirium, which is assessed using the Confusion Assessment Method-Intensive Care Unit (CAM-ICU). Chronic neurological dysfunction is defined as having quantitative impairments on robotic testing (KINARM robot) and traditional neuropsychological screening (Repeatable Battery for the Assessment of Neuropsychological Status).

Condition or disease
Critical Illness Respiratory Failure Shock Delirium

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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Cerebral Oxygenation and Neurological Outcomes FOllowing CriticAL Illness-2
Actual Study Start Date : October 13, 2017
Estimated Primary Completion Date : June 2022
Estimated Study Completion Date : June 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Delirium

Group/Cohort
Respiratory failure and/or shock
All enrolled patients will undergo 72 hours of monitoring of cerebral oxygenation with near-infrared spectroscopy.



Primary Outcome Measures :
  1. Brain tissue oxygenation and delirium [ Time Frame: 30 days ]
    Assessment of primary outcome: The primary hypothesis of this study is the association between BtO2 and the amount of non-comatose (i.e. RASS -4 or -5) days a patient is CAM-ICU positive (i.e. delirious). Statistical diagnostics (e.g. assessment for normality) will determine the use of parametric (Pearson) or non-parametric (Spearman's rank) correlational analysis on this data set. A correlation will be considered statistically significant if p<0.05.


Secondary Outcome Measures :
  1. Assessment of secondary outcomes-physiological determinants of brain tissue oxygenation [ Time Frame: 72 hours ]
    Simultaneous multiple linear regression analysis will be used to investigate if clinically relevant hemodynamic and physiological parameters (E.g. MAP, HR, SaO2, and pCO2) predict NIRS derived BtO2.

  2. Brain tissue oxygenation as an independent risk factor for delirium [ Time Frame: 30 days ]
    To determine if BtO2 is an independent predictor of delirium, logistic regression will be used to estimate the unadjusted effect of each individual predictor on delirium duration (i.e. the number of CAM-ICU positive days). The following covariates were selected a priori, as they have been associated with delirium: a history of cognitive dysfunction, a history of hypertension, a history of alcohol abuse, MAP, blood urea nitrogen, and total narcotic dose (in fentanyl equivalents).

  3. Brain tissue oxygenation as an independent risk factor for long-term cognitive impairment-RBANS [ Time Frame: 3 months and 12 months ]
    The Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) will be administered among ICU survivors. We will use simultaneous multiple linear regression analysis to investigate if clinical variables available on admission (e.g. history of hypertension) and data collected within the first 72 hours of the patients' ICU stay (e.g. brain tissue oxygenation) can predict participant performance on the RBANS (i.e. total score and each cognitive domain) administered at 3 and 12 month after ICU discharge.

  4. Brain tissue oxygenation as an independent risk factor for long-term cognitive impairment-KINARM [ Time Frame: 3 months and 12 months ]
    The KINARM robot will be used to assess sensorimotor and neurocognitive control of limb movements in ICU survivors. We will use simultaneous multiple linear regression analysis to investigate if clinical variables available on admission (e.g. history of hypertension) and data collected within the first 72 hours of the patients' ICU stay (e.g. brain tissue oxygenation) can predict participant performance on the KINARM (i.e. task/total score for each subtask) administered at 3 and 12 month after ICU discharge.


Biospecimen Retention:   Samples Without DNA
Samples will be collected for proteomic assessments.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
We will be enrolling consecutive patients meeting eligibility criteria from each site in this multi-centred study.
Criteria

Inclusion

  1. Adults ≥ 18 years old
  2. Admitted to a critical care unit requiring one or more of the following:

    (a) Respiratory failure requiring invasive mechanical ventilation with an expected duration >24 hours (b) Shock of any etiology. Shock is defined by the need for one of the following vasopressors/inotropes: (i) Dopamine ≥7.5 mcg/kg/min (ii) Dobutamine ≥5 mcg/kg/min (iii) Norepinephrine ≥5 mcg/min (iv) Phenylephrine ≥75 mcg/min (v) Epinephrine at any dose (vi) Milrinone at any dose (if used in conjunction with another agent) (vii) Vasopressin ≥0.03 u/min(if used in conjunction with another agent)

Exclusion:

  1. Admission to the ICU > 24 hours
  2. Life expectancy <24 hours
  3. Admitting diagnosis that affects the central nervous system
  4. Any reason that the subject may not be able to participate in the follow up assessments (i.e. limb amputation, paresis, neuromuscular disorders)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03141619


Contacts
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Contact: J. Gordon Boyd, MD, PhD 613-549-6666 ext 6228 boydj@kgh.kari.net
Contact: Miranda Hunt 613-549-6666 huntm4@KGH.KARI.NET

Locations
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Canada, Ontario
Kingston General Hospital Recruiting
Kingston, Ontario, Canada, K7L3V7
Contact: John G Boyd, MD, PhD    613-549-6666 ext 6228    2jgb1@queensu.ca   
Sponsors and Collaborators
Queen's University
University Health Network, Toronto
Vancouver General Hospital
University of Western Ontario, Canada
Investigators
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Principal Investigator: J. Gordon Boyd, MD, PhD Queen's University

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Responsible Party: Dr. Gordon Boyd, Assistant Professor, Queen's University
ClinicalTrials.gov Identifier: NCT03141619     History of Changes
Other Study ID Numbers: not yet available
First Posted: May 5, 2017    Key Record Dates
Last Update Posted: March 20, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Dr. Gordon Boyd, Queen's University:
cerebral oximetry
near-infrared spectroscopy
neurocognitive
post-ICU syndrome

Additional relevant MeSH terms:
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Delirium
Respiratory Insufficiency
Critical Illness
Confusion
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Neurocognitive Disorders
Mental Disorders
Respiration Disorders
Respiratory Tract Diseases
Disease Attributes
Pathologic Processes