Neurocognitive Outcomes for ICU Patients With Acute Kidney Injury

NCT ID: NCT04722939

Last Updated: 2023-12-26

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 104 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2021-01-15
• Study Completion Date: 2027-01-01

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.

Conditions

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Critical illness with acute kidney injury

See below for detailed inclusion/exclusion criteria

Cerebral oxygenation

Intervention Type: 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

Interventions

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

Intervention Type: DIAGNOSTIC_TEST

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Dr. Gordon Boyd

OTHER

Sponsor Role: lead

Responsible Party

Dr. Gordon Boyd

Associate Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Kingston Health Sciences Centre

Kingston, Ontario, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

J. Gordon Boyd, MD, PhD

Role: CONTACT

Phone: 613-549-6666

Email: gordon.boyd@kingstonhsc.ca

Tasha Jawa, MSc

Role: CONTACT

Phone: 416-627-1508

Email: tasha.jawa@queensu.ca

Facility Contacts

J G Boyd, MD, PhD

Role: primary

Tasha Jawa, MSc.

Role: backup

References

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.

Reference Type: DERIVED

PMID: 37644980 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 34404711 (View on PubMed)

Other Identifiers

DMED-2424-20

Identifier Type: -

Identifier Source: org_study_id