Neurocognitive Outcomes for ICU Patients With Acute Kidney Injury

NCT04722939 | Recruiting

• 1 other identifier: DMED-2424-20
• Study Type: observational
• Target: 104
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Cognitive Impairment-Kinarm

  3 months and 12 months

• Cognitive Impairment-Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)

  3 months and 12 months

• Medication adherence

  12 months

• Driving safety-1

  12 months

• Driving safety-2

  12 months

Study Arms (1)

Critical illness with acute kidney injury

See below for detailed inclusion/exclusion criteria

Diagnostic Test: Cerebral oxygenation

Interventions

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

Critical illness with acute kidney injury

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dr. Gordon Boyd: lead

Study Sites (1)

Kingston Health Sciences Centre

Kingston, Ontario, K7L3C9, Canada

RECRUITING

Related Publications (2)

• 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.

  PMID: 37644980 DERIVED

• 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.

  PMID: 34404711 DERIVED

MeSH Terms

Conditions

Delirium; Acute Kidney Injury; Critical Illness; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Disease Attributes; Pathologic Processes; Cognition Disorders

Central Study Contacts

J. Gordon Boyd, MD, PhD

CONTACT

613-549-6666; gordon.boyd@kingstonhsc.ca

Tasha Jawa, MSc

CONTACT

416-627-1508; tasha.jawa@queensu.ca

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: January 19, 2021
• First Posted: January 25, 2021
• Study Start: January 15, 2021
• Primary Completion: January 1, 2026
• Study Completion (Estimated): January 1, 2027
• Last Updated: December 26, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: We are in the final stages of submitting our study protocol for peer review.

Locations

CA (1)