Cerebral Oxygenation and Neurological Outcomes FOllowing CriticAL Illness-2

NCT03141619 | Unknown DMC

• 1 other identifier: CTO Project ID 0815
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

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).

Conditions

Critical Illness; Respiratory Failure; Shock; Delirium

Keywords

cerebral oximetry; near-infrared spectroscopy; neurocognitive; post-ICU syndrome

Outcome Measures

Primary Outcomes (1)

• Regional cerebral oxygenation (rSO2) and delirium

  Multivariate linear regression will be used to characterize the association between poor cerebral perfusion (as measured using duration of time (minutes) outside of MAPOPT, mean rSO2, and duration of disturbed cerebral autoregulation) and delirium severity to determine if poor cerebral perfusion is an independent predictor of delirium severity. We will estimate the unadjusted effect of each individual predictor on delirium severity (i.e., cumulative CAM-7 scores per patient). The simultaneous multivariate regression model will adjust for the following covariates (sex, a history of hypertension, a history of alcohol abuse, total sedative dose (in midazolam equivalents), total narcotic dose (fentanyl equivalents), severity of illness (APACHE II scores), pre-existing cognitive impairment (CDR score), length of ICU stay, and blood urea nitrogen. The multivariable model will provide the adjusted regression coefficients after controlling for all predictors included in the model.

  30 days

Secondary Outcomes (2)

• Assessment of secondary outcomes-physiological determinants of cerebral oxygenation

  72 hours

• Cerebral oxygenation as an independent risk factor for long-term cognitive impairment-RBANS

  3 months and 12 months

Other Outcomes (2)

• Time outside optimal MAP

  72h, 3- and 12-months

• Robotic quantification of neurological recovery

  3 and 12 months

Study Arms (1)

Respiratory failure and/or shock

All enrolled patients will undergo 72 hours of monitoring of cerebral oxygenation with near-infrared spectroscopy.

Eligibility Criteria

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

Study Population

We will be enrolling consecutive patients meeting eligibility criteria from each site in this multi-centred study.

You may qualify if:

• Adults ≥ 18 years old
• 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)

You may not qualify if:

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

Sponsors & Collaborators

• Dr. Gordon Boyd: lead
• University Health Network, Toronto: collaborator
• Vancouver General Hospital: collaborator
• Western University, Canada: collaborator
• University of Ottawa: collaborator
• Université de Montréal: collaborator
• University of Calgary: collaborator
• University of Pittsburgh: collaborator

Study Sites (1)

Kingston General Hospital

Kingston, Ontario, K7L3V7, Canada

RECRUITING

Related Publications (2)

• 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.

  PMID: 32780600 DERIVED

• 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.

  PMID: 31243036 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Samples will be collected for proteomic assessments.

MeSH Terms

Conditions

Critical Illness; Respiratory Insufficiency; Shock; Delirium

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Respiration Disorders; Respiratory Tract Diseases; Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Study Officials

• J. Gordon Boyd, MD, PhD

  Queen's University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

J. Gordon Boyd, MD, PhD

CONTACT

613-549-6666; boydj@kgh.kari.net

Miranda Hunt

CONTACT

613-549-6666; huntm4@KGH.KARI.NET

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: May 1, 2017
• First Posted: May 5, 2017
• Study Start: October 13, 2017
• Primary Completion: June 1, 2024
• Study Completion: June 1, 2025
• Last Updated: December 26, 2023

Record last verified: 2023-12

Locations

CA (1)