Recruiting

Observational Study

Sponsor:

Dr. Gordon Boyd

Code:

NCT04722939

Conditions

Delirium

Acute Kidney Injury

Critical Illness

Cognitive Impairment

Cerebral Oxygenation

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Cerebral oxygenation

Study Details

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

Study ID

NCT04722939

Start date

Jan 15, 2021

Status verified date

Dec, 2023

Completion date

Jan 1, 2027

Anticipated

Primary completion date

Jan 1, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

104 participants

Anticipated

Interventions and Outcome Measures

Arms

Critical illness with acute kidney injury

See below for detailed inclusion/exclusion criteria

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

Primary outcome measure

  • Delirium Severity [ Time Frame: 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. ]

Central Contacts and Locations

Central contacts

Locations

Kingston Health Sciences Centre

Recruiting

Kingston, Ontario, Canada, K7L3C9

Contacts

More Information

Sponsor

Dr. Gordon Boyd

Last update posted

Dec 26, 2023

Last verified

Dec, 2023

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Dr. Gordon Boyd on 2023-12-26.