Clinical trial NCT04722939: Neurocognitive Outcomes for ICU Patients With Acute Kidney Injury
Official title: Identifying Neurocognitive Outcomes and Cerebral Oxygenation in Critically Ill Adults on Acute Kidney Replacement Therapy in the Intensive Care Unit
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Delirium
Acute Kidney Injury
Critical Illness
Cognitive Impairment
Cerebral Oxygenation
Cerebral Autoregulation
Lead sponsor: Queen's University
Sponsor class: OTHER
First posted: 2021-01-25
Enrollment: 104
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: Patients will be recruited from the Kingston Health Sciences Centre Intensive Care Unit (ICU), which is a 33-bed medical/surgical/trauma/neurological ICU. Patients admitted to the ICU generally require invasive mechanical ventilation for respiratory failure and/or vasoactive medications for hemodynamic support.

Brief summary: Introduction. Initiation of acute kidney replacement therapy (KRT) is common in critically ill adults admitted to the intensive care unit (ICU), and is associated with increased morbidity and mortality. KRT has been linked to poor neurocognitive outcomes, leading to a reduced quality of life, as well as increased utilization of healthcare resources. Adults initiated on dialysis in the ICU may be particularly at risk of neurocognitive impairment, as survivors of critical illness are already predisposed to developing cerebrovascular disease and cognitive dysfunction over the long-term relative to healthy controls. Regional cerebral oxygen saturation (rSO2) may provide a critical early marker of long-term neurocognitive impairment in patients in this population. The INCOGNITO-AKI study aims to understand cerebral oxygenation in patients undergoing KRT, either continuous or intermittent, in the ICU. These findings will be correlated with long-term cognitive and functional outcomes, as well as structural brain pathology.

Methods and analysis. 108 patients scheduled to undergo treatment for acute kidney injury with KRT in the Kingston Health Sciences Centre ICU will be recruited into this prospective observational study. Enrolled patients will be assessed with intradialytic cerebral oximetry using near infrared spectroscopy (NIRS). Delirium will be assessed daily with the Confusion Assessment Method-Intensive Care Unit (CAM-ICU) and delirium severity quantified as cumulative CAM-ICU-7 scores. Neurocognitive impairment will be assessed at 3- and 12-months after hospital discharge using the Kinarm and Repeatable Battery for the Assessment of Neuropsychological Status (RBANS). Structural brain pathology on MRI will also be measured at the same timepoints. Driving safety, adverse events, and medication adherence will be assessed at 12-months to evaluate the impact of neurocognitive impairment on functional outcomes.

Ethics and dissemination. This study has been approved by the Queen's University Health Sciences and Affiliated Teaching Hospitals Research Ethics Board (Approval number: DMED-2424-20). Results will be presented at critical care scientific conferences and a lay summary will be provided to patients and families in their preferred format.


Eligibility criteria: Inclusion Criteria:

* age greater than or equal to 18 years
* admitted to the Kingston Health Sciences Intensive Care Unit
* diagnosis of severe AKI requiring Kidney Replacement Therapy (KRT) (defined by the presence of either a twofold increase in serum creatinine from baseline, serum creatinine level greater than or equal to 354 micromol/L with an increase of 27 micromol/L from baseline, or urine output \<6 mL/kg in the preceding 12 hours)
* within 12 hours of initiation of KRT via intermittent hemodialysis (iHD) or continuous kidney replacement therapy (CKRT).

Exclusion Criteria:

* acquired or congenital neurological disorders
* any contraindication to testing with cerebral oximetry, Kinarm, or MRI (e.g., claustrophobia, limb amputation, paresis, neuromuscular disorders, etc.)
* KRT via PD
* failure to consent
* life expectancy less than 24 hours
* clinical suspicion of renal obstruction
* rapidly progressive glomerulonephritis or interstitial nephritis
* prehospitalization eGFR \<30 mL/min/1.73m2.

Primary outcomes:
measure: Delirium Severity
timeFrame: Patients will be screened daily in the ICU with the CAM-ICU-7 score up until the date of ICU discharge or day 30 of ICU stay.
Secondary outcomes:
measure: Cognitive Impairment-Kinarm
timeFrame: 3 months and 12 months
measure: Cognitive Impairment-Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)
timeFrame: 3 months and 12 months
measure: Medication adherence
timeFrame: 12 months
measure: Driving safety-1
timeFrame: 12 months
measure: Driving safety-2
timeFrame: 12 months
measure: Health care utilization
timeFrame: Within 12 months of hospital discharge.
measure: Structural brain imaging
timeFrame: 3 months and 12 months
Other outcomes:
Locations:
city: Kingston
country: Canada
facility: Kingston Health Sciences Centre
state: Ontario
Study officials:
References:
citation: Jawa NA, Holden RM, Silver SA, Scott SH, Day AG, Norman PA, Kwan BYM, Maslove DM, Muscedere J, Boyd JG. Identifying neurocognitive outcomes and cerebral oxygenation in critically ill adults on acute kidney replacement therapy in the intensive care unit: the INCOGNITO-AKI study protocol. BMJ Open. 2021 Aug 17;11(8):e049250. doi: 10.1136/bmjopen-2021-049250.