Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Critical illness with acute kidney injury | See below for detailed inclusion/exclusion criteria |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cerebral oxygenation | Diagnostic Test | Cerebral oxygenation will be monitored with the FORESIGHT Elite cerebral oximeter during the first 72h of critical illness, and during subsequent hemodialysis sessions |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Cognitive Impairment-Kinarm | Patients will undergo a neurocognitive battery with the Kinarm robot and Kinarm standardized tests. | 3 months and 12 months |
| Cognitive Impairment-Repeatable Battery for the Assessment of Neuropsychological Status (RBANS) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| J. Gordon Boyd, MD, PhD | Contact | 613-549-6666 | 6228 | gordon.boyd@kingstonhsc.ca |
| Tasha Jawa, MSc | Contact | 416-627-1508 | tasha.jawa@queensu.ca |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kingston Health Sciences Centre | Recruiting | Kingston | Ontario | K7L3C9 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37644980 | Derived | Jawa NA, Silver SA, Holden RM, Scott SH, Day AG, Norman PA, Kwan BYM, Maslove DM, Muscedere J, Boyd JG. Neurological Impairment in Critically Ill Patients on Dialysis: Research Letter for the INCOGNITO-AKI Feasibility Study. Can J Kidney Health Dis. 2023 Aug 24;10:20543581231192743. doi: 10.1177/20543581231192743. eCollection 2023. | |
| 34404711 |
Not provided
Not provided
De-identified individualized patient data will be made available upon reasonable request.
We are in the final stages of submitting our study protocol for peer review.
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D003693 | Delirium |
| D058186 | Acute Kidney Injury |
| D016638 | Critical Illness |
| D060825 | Cognitive Dysfunction |
| ID | Term |
|---|---|
| D003221 | Confusion |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Patients will undergo assessment with the RBANS administered by a trained researcher.
| 3 months and 12 months |
| Medication adherence | Medication adherence will be assessed with the Medication Adherence Rating Scale (MARS) | 12 months |
| Driving safety-1 | Driving safety will be assessed by number of motor vehicle accidents. | 12 months |
| Driving safety-2 | Driving safety will be assessed by and the Manchester Driver Behavior Questionnaire | 12 months |
| Health care utilization | We will measure emergency department visits and hospital readmissions. | Within 12 months of hospital discharge. |
| 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 |
| 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. |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D003072 | Cognition Disorders |