Neurocognitive Outcomes for ICU Patients With Acute Kidney Injury

Critical Illness Clinical Trial

— INCOGNITOAKI  

Official title:

Identifying Neurocognitive Outcomes and Cerebral Oxygenation in Critically Ill Adults on Acute Kidney Replacement Therapy in the Intensive Care Unit

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04722939
• Other study ID #: DMED-2424-20
• Status: Recruiting
• Start date: January 15, 2021
• Est. completion date: January 1, 2027

Study information

• Verified date: December 2023
• Source: Queen's University
• Contact: J. Gordon Boyd, MD, PhD
• Phone: 613-549-6666
• Email: gordon.boyd[@]kingstonhsc.ca
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 104
• Est. completion date: January 1, 2027
• Est. primary completion date: January 1, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Acute Kidney Injury
• Cerebral Autoregulation
• Cerebral Oxygenation
• Cognitive Impairment
• Critical Illness
• Delirium

Intervention

Diagnostic Test:
• Cerebral oxygenation
Cerebral oxygenation will be monitored with the FORESIGHT Elite cerebral oximeter during the first 72h of critical illness, and during subsequent hemodialysis sessions

Locations

Country	Name	City	State
Canada	Kingston Health Sciences Centre	Kingston	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Dr. Gordon Boyd

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Delirium Severity	Delirium severity will be calculated from the cumulated Confusion Assessment Method-Intensive Care Unit-7 (CAM-ICU-7) score	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	Cognitive Impairment-Kinarm	Patients will undergo a neurocognitive battery with the Kinarm robot and Kinarm standardized tests.	3 months and 12 months
Secondary	Cognitive Impairment-Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)	Patients will undergo assessment with the RBANS administered by a trained researcher.	3 months and 12 months
Secondary	Medication adherence	Medication adherence will be assessed with the Medication Adherence Rating Scale (MARS)	12 months
Secondary	Driving safety-1	Driving safety will be assessed by number of motor vehicle accidents.	12 months
Secondary	Driving safety-2	Driving safety will be assessed by and the Manchester Driver Behavior Questionnaire	12 months
Secondary	Health care utilization	We will measure emergency department visits and hospital readmissions.	Within 12 months of hospital discharge.
Secondary	Structural brain imaging	Anonymized and de-identified MRI scans will be processed using MIPAV55 v.7.3.0 and Oxford Centre for Functional MRI of the Brain (FMRIB) Software Library (FSL) v.5.0 medical image processing programs. Scans will be corrected for intensity non-uniformity and transformed into a common image space to adjust for variations in head size and orientation. Skull stripping will be performed. Automated and semi-automated techniques will be used to determine whole-brain volumes from T1-weighted images for analysis of macrostructural brain integrity, as well as FA and MD measures from diffusion-weighted images for analysis of microstructural brain integrity. Brain volumes will be corrected for total intracranial volume to account for head size. Reasons for non-completion of MRI scanning will be recorded. Patients will be used as their own controls over time using a within-subjects design.	3 months and 12 months