Clinical trial NCT03141619: Cerebral Oxygenation and Neurological Outcomes FOllowing CriticAL Illness-2
Official title: Cerebral Oxygenation and Neurological Outcomes FOllowing CriticAL Illness-2
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Critical Illness
Respiratory Failure
Shock
Delirium
Keywords: cerebral oximetry
near-infrared spectroscopy
neurocognitive
post-ICU syndrome
Lead sponsor: Queen's University
Sponsor class: OTHER
Collaborators: name: University Health Network, Toronto
name: Vancouver General Hospital
name: Western University, Canada
name: University of Ottawa
name: Université de Montréal
name: University of Calgary
name: University of Pittsburgh
First posted: 2017-05-05
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: We will be enrolling consecutive patients meeting eligibility criteria from each site in this multi-centred study.

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).


Eligibility 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)

Primary outcomes:
measure: Regional cerebral oxygenation (rSO2) and delirium
timeFrame: 30 days
Secondary outcomes:
measure: Assessment of secondary outcomes-physiological determinants of cerebral oxygenation
timeFrame: 72 hours
measure: Cerebral oxygenation as an independent risk factor for long-term cognitive impairment-RBANS
timeFrame: 3 months and 12 months
Other outcomes:
measure: Time outside optimal MAP
timeFrame: 72h, 3- and 12-months
measure: Robotic quantification of neurological recovery
timeFrame: 3 and 12 months
Locations:
city: Kingston
country: Canada
facility: Kingston General Hospital
state: Ontario
Study officials:
affiliation: Queen's University
name: J. Gordon Boyd, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Khan JM, Wood MD, Lee KFH, Maslove D, Muscedere J, English SW, Ball I, Slessarev M, Boyd JG. Delirium, Cerebral Perfusion, and High-Frequency Vital-Sign Monitoring in the Critically Ill. The CONFOCAL-2 Feasibility Study. Ann Am Thorac Soc. 2021 Jan;18(1):112-121. doi: 10.1513/AnnalsATS.202002-093OC.
citation: Wood MD, Khan J, Lee KFH, Maslove DM, Muscedere J, Hunt M, Scott SH, Day A, Jacobson JA, Ball I, Slessarev M, O'Regan N, English SW, McCredie V, Chasse M, Griesdale D, Boyd JG. Assessing the relationship between near-infrared spectroscopy-derived regional cerebral oxygenation and neurological dysfunction in critically ill adults: a prospective observational multicentre protocol, on behalf of the Canadian Critical Care Trials Group. BMJ Open. 2019 Jun 25;9(6):e029189. doi: 10.1136/bmjopen-2019-029189.