Ignite Creation Date:
2024-05-06 @ 3:41 PM
Last Modification Date:
2024-10-26 @ 1:54 PM
Study NCT ID:
NCT04722939
Status:
RECRUITING
Last Update Posted:
2023-12-26
First Post:
2021-01-19
Brief Title:
Neurocognitive Outcomes for ICU Patients With Acute Kidney Injury
Sponsor:
Dr Gordon Boyd
Organization:
Queens University
Study Overview
Official Title:
Identifying Neurocognitive Outcomes and Cerebral Oxygenation in Critically Ill Adults on Acute Kidney Replacement Therapy in the Intensive Care Unit
Status:
RECRUITING
Status Verified Date:
2023-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
INCOGNITOAKI
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 Queens 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
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 Queens 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None