DeliriumINCOGNITOAKINCT04722939
Neurocognitive Outcomes for ICU Patients With Acute Kidney Injury
An observational study of Delirium and Acute Kidney Injury, run by Dr. Gordon Boyd at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Delirium, Acute Kidney Injury, Critical Illness
- What is being tested?
- Cerebral oxygenation
- How many people
- 104 participants
- Where
- 1 siteCanada
- Study dates
- 15 Jan 2021to 1 Jan 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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).
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
Kingston Health Sciences Centre
Kingston, Ontario, K7L3C9
J G Boyd, MD, PhD, 6135392754, gordon.boyd@kingstonhsc.ca
Tasha Jawa, MSc., 416-627-1508, tasha.jawa@queensu.ca
About this study
Official title: Identifying Neurocognitive Outcomes and Cerebral Oxygenation in Critically Ill Adults on Acute Kidney Replacement Therapy in the Intensive Care Unit
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
- Being tested
- Cerebral oxygenation
- Medical subject headings
- Delirium, Acute Kidney Injury, Critical Illness, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cerebral oxygenationDiagnostic test
Cerebral oxygenation will be monitored with the FORESIGHT Elite cerebral oximeter during the first 72h of critical illness, and during subsequent hemodialysis sessions
| Study group | Role | What they receive |
|---|---|---|
| Critical illness with acute kidney injury | See below for detailed inclusion/exclusion criteria Receives: Diagnostic Test: Cerebral oxygenation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Delirium Severity
Delirium severity will be calculated from the cumulated Confusion Assessment Method-Intensive Care Unit-7 (CAM-ICU-7) score
Measured: 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
Patients will undergo a neurocognitive battery with the Kinarm robot and Kinarm standardized tests.
Measured: 3 months and 12 months
Cognitive Impairment-Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)
Patients will undergo assessment with the RBANS administered by a trained researcher.
Measured: 3 months and 12 months
Medication adherence
Medication adherence will be assessed with the Medication Adherence Rating Scale (MARS)
Measured: 12 months
Driving safety-1
Driving safety will be assessed by number of motor vehicle accidents.
Measured: 12 months
Driving safety-2
Driving safety will be assessed by and the Manchester Driver Behavior Questionnaire
Measured: 12 months
Health care utilization
We will measure emergency department visits and hospital readmissions.
Measured: Within 12 months of hospital discharge.
Structural brain imaging
Anonymized and de-identified MRI scans will be processed using MIPAV55 v.7.3.0 and Oxford Centre for Functional MRI of the Brain (FMRIB) Software Library (FSL) v.5.0 medical image processing programs. Scans will be corrected for intensity non-uniformity and transformed into a common image space to adjust for variations in head size and orientation. Skull stripping will be performed. Automated and semi-automated techniques will be used to determine whole-brain volumes from T1-weighted images for analysis of macrostructural brain integrity, as well as FA and MD measures from diffusion-weighted images for analysis of microstructural brain integrity. Brain volumes will be corrected for total intracranial volume to account for head size. Reasons for non-completion of MRI scanning will be recorded. Patients will be used as their own controls over time using a within-subjects design.
Measured: 3 months and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2021
- Study start15 Jan 2021
- Primary completion1 Jan 2026 (estimated)
- Study completion1 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for DeliriumStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 104 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dr. Gordon Boyd
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Dr. Gordon Boyd, Queen's University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04722939
- Sponsor's protocol ID
- DMED-2424-20
- Acronym
- INCOGNITOAKI
- Status last verified
- Dec 2023
- First submitted
- 19 Jan 2021
- Last updated
- 26 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individualized patient data will be made available upon reasonable request.
Publications
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.
PubMed 37644980Jawa 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.
PubMed 34404711
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identifying Neurocognitive Outcomes and Cerebral Oxygenation in Critically Ill Adults on Acute Kidney Replacement Therapy in the Intensive Care Unit
- ClinicalTrials.gov ID
- NCT04722939
- Acronym / sponsor ID
- INCOGNITOAKI / DMED-2424-20
- Conditions
- Delirium, Acute Kidney Injury, Critical Illness, Cognitive Impairment, Cerebral Oxygenation, Cerebral Autoregulation
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 104 participants (estimated)
- Lead sponsor
- Dr. Gordon BoydUniversity, hospital or other
- Study start
- 15 Jan 2021 (actual)
- Primary completion
- 1 Jan 2026 (estimated)
- Study completion
- 1 Jan 2027 (estimated)
- First posted
- 25 Jan 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Critical illness with acute kidney injury | – | Diagnostic Test: Cerebral oxygenationSee below for detailed inclusion/exclusion criteria |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cerebral oxygenationCerebral oxygenation will be monitored with the FORESIGHT Elite cerebral oximeter during the first 72h of critical illness, and during subsequent hemodialysis sessions | Diagnostic test | Critical illness with acute kidney injury |
Primary outcome
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.
Delirium severity will be calculated from the cumulated Confusion Assessment Method-Intensive Care Unit-7 (CAM-ICU-7) score
7 secondary outcomes
Cognitive Impairment-Kinarm
Time frame: 3 months and 12 months
Cognitive Impairment-Repeatable Battery for the Assessment of Neuropsychological Status (RBANS)
Time frame: 3 months and 12 months
Medication adherence
Time frame: 12 months
Driving safety-1
Time frame: 12 months
Driving safety-2
Time frame: 12 months
Health care utilization
Time frame: Within 12 months of hospital discharge.
Structural brain imaging
Time frame: 3 months and 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Dec 2023.
- Derived from this study: PubMed 37644980Jawa 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.
- Derived from this study: PubMed 34404711Jawa 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.
- Individual participant dataSharing planned: Yes. De-identified individualized patient data will be made available upon reasonable request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Delirium and Acute Kidney Injury, run by Dr. Gordon Boyd at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 26 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact J. Gordon Boyd, MD, PhD (613-549-6666 ext. 6228, gordon.boyd@kingstonhsc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04722939, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Dec 2023.