Actively Recruiting

Age: 18Years +
All Genders
ID04722939

Identifying Neurocognitive Outcomes and Cerebral Oxygenation in Critically Ill Adults on Acute Kidney Replacement Therapy in the Intensive Care Unit

Led by Dr. Gordon Boyd · Updated on 2023-12-26

104

Participants Needed

1

Research Sites

52 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This research aims to understand brain oxygen levels and their link to long-term thinking and functional outcomes in adults who are critically ill with acute kidney injury (AKI) and need kidney replacement therapy (KRT) in the intensive care unit (ICU). Patients starting dialysis in the ICU may face risks of brain problems, including delirium and cognitive impairment, which affect quality of life and healthcare use. The study is observational and focuses on cerebral oxygenation as an early marker for these outcomes. Participants will undergo monitoring of cerebral oxygen saturation using near infrared spectroscopy with the FORESIGHT Elite cerebral oximeter during the first 72 hours of their critical illness and during dialysis treatments. The study includes patients receiving either intermittent hemodialysis or continuous kidney replacement therapy within 12 hours of starting treatment. Various tests will be done to assess brain function, including structural brain imaging with MRI and neurocognitive testing at 3 and 12 months after hospital discharge. Throughout the ICU stay, delirium will be checked daily using the Confusion Assessment Method for the ICU (CAM-ICU) and severity scored with CAM-ICU-7. Follow-up assessments at 3 and 12 months will measure neurocognitive function, medication adherence, driving safety, and healthcare use. The study lasts at least one year post-discharge to evaluate the long-term impact on brain health and daily function.

CONDITIONS

Brief Title

Neurocognitive Outcomes for ICU Patients With Acute Kidney Injury

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Age 18 years or older
  • Admitted to the Kingston Health Sciences Intensive Care Unit
  • Diagnosed with severe acute kidney injury requiring kidney replacement therapy
  • Initiated kidney replacement therapy within 12 hours via intermittent hemodialysis or continuous therapy
Not Eligible

You will not qualify if you...

  • Acquired or congenital neurological disorders
  • Contraindications to cerebral oximetry, Kinarm, or MRI testing (e.g., claustrophobia, limb amputation, paresis, neuromuscular disorders)
  • Receiving peritoneal dialysis
  • Unable to provide consent
  • Life expectancy less than 24 hours
  • Clinical suspicion of renal obstruction
  • Rapidly progressive glomerulonephritis or interstitial nephritis
  • Prehospitalization estimated glomerular filtration rate less than 30 mL/min/1.73m2

AI-Screening

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - Up to 3 days during initial critical illness and during hemodialysis sessions

Participants undergo cerebral oxygenation monitoring during the first 72 hours of critical illness and during subsequent hemodialysis sessions.

Multiple monitoring sessions during ICU stay

Long-term Monitoring

Duration - 12 months following hospital discharge

Participants are assessed for neurocognitive outcomes, medication adherence, driving safety, health care utilization, and undergo structural brain imaging at 3 months and 12 months after hospital discharge.

Assessments at 3 months and 12 months post-discharge

Trial Site Locations

Total: 1 location

1

Kingston Health Sciences Centre

Kingston, Ontario, Canada, K7L3C9

Actively Recruiting

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Research Team

J

J. Gordon Boyd, MD, PhD

T

Tasha Jawa, MSc

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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Published Research Related To This Trial

Neurological Impairment in Critically Ill Patients on Dialysis: Research Letter for the INCOGNITO-AKI Feasibility Study.

Natasha A Jawa, Samuel A Silver, Rachel M Holden...

https://pubmed.ncbi.nlm.nih.gov/37644980

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.

Natasha Arianne Jawa, Rachel M Holden, Samuel A Silver...

https://pubmed.ncbi.nlm.nih.gov/34404711