NCT04722939 Neurocognitive Outcomes for ICU Patients With Acute Kidney Injury
| NCT ID | NCT04722939 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Dr. Gordon Boyd |
| Condition | Delirium |
| Study Type | OBSERVATIONAL |
| Enrollment | 104 participants |
| Start Date | 2021-01-15 |
| Primary Completion | 2026-01-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 104 participants in total. It began in 2021-01-15 with a primary completion date of 2026-01-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT04722939 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Delirium. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04722939 currently recruiting?
Yes, NCT04722939 is actively recruiting participants. Contact the research team at gordon.boyd@kingstonhsc.ca for enrollment information.
Where is the NCT04722939 trial being conducted?
This trial is being conducted at Kingston, Canada.
Who is sponsoring the NCT04722939 clinical trial?
NCT04722939 is sponsored by Dr. Gordon Boyd. The trial plans to enroll 104 participants.