Neurocognitive Outcomes for ICU Patients With Acute Kidney Injury

Status Recruiting

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT04722939
Study type	Observational
Source	Queen's University
Contact	J. Gordon Boyd, MD, PhD
Phone	613-549-6666
Email	gordon.boyd@kingstonhsc.ca
Status	Recruiting
Phase
Start date	January 15, 2021
Completion date	January 1, 2027

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT04551508` - Delirium Screening 3 Methods Study
Recruiting	`NCT06037928` - Plasma Sodium and Sodium Administration in the ICU
Completed	`NCT03671447` - Enhanced Recovery After Intensive Care (ERIC)	N/A
Recruiting	`NCT03941002` - Continuous Evaluation of Diaphragm Function	N/A
Recruiting	`NCT04674657` - Does Extra-Corporeal Membrane Oxygenation Alter Antiinfectives Therapy Pharmacokinetics in Critically Ill Patients
Completed	`NCT04239209` - Effect of Intensivist Communication on Surrogate Prognosis Interpretation	N/A
Completed	`NCT05531305` - Longitudinal Changes in Muscle Mass After Intensive Care	N/A
Terminated	`NCT03335124` - The Effect of Vitamin C, Thiamine and Hydrocortisone on Clinical Course and Outcome in Patients With Severe Sepsis and Septic Shock	Phase 4
Completed	`NCT02916004` - The Use of Nociception Flexion Reflex and Pupillary Dilatation Reflex in ICU Patients.	N/A
Recruiting	`NCT05883137` - High-flow Nasal Oxygenation for Apnoeic Oxygenation During Intubation of the Critically Ill
Completed	`NCT04479254` - The Impact of IC-Guided Feeding Protocol on Clinical Outcomes in Critically Ill Patients (The IC-Study)	N/A
Recruiting	`NCT04475666` - Replacing Protein Via Enteral Nutrition in Critically Ill Patients	N/A
Not yet recruiting	`NCT04538469` - Absent Visitors: The Wider Implications of COVID-19 on Non-COVID Cardiothoracic ICU Patients, Relatives and Staff
Not yet recruiting	`NCT04516395` - Optimizing Antibiotic Dosing Regimens for the Treatment of Infection Caused by Carbapenem Resistant Enterobacteriaceae	N/A
Withdrawn	`NCT04043091` - Coronary Angiography in Critically Ill Patients With Type II Myocardial Infarction	N/A
Recruiting	`NCT02989051` - Fluid Restriction Keeps Children Dry	Phase 2/Phase 3
Recruiting	`NCT02922998` - CD64 and Antibiotics in Human Sepsis	N/A
Completed	`NCT02899208` - Can an Actigraph be Used to Predict Physical Function in Intensive Care Patients?	N/A
Completed	`NCT03048487` - Protein Consumption in Critically Ill Patients
Recruiting	`NCT02163109` - Oxygen Consumption in Critical Illness

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Neurocognitive Outcomes for ICU Patients With Acute Kidney Injury — INCOGNITOAKI

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms