The Kidney and The Brain Study - Assessment of Cognitive Impairment in Advanced CKD

NCT03382444 | Completed

• 1 other identifier: 17/233064-S
• Study Type: observational
• Target: 19
• Locations: 1 country
• Sites: 1

Brief Summary

Patients with failed kidneys need Renal Replacement Therapy (RRT) to remove fluid and toxins from the body. The 3 types of RRT are kidney transplant or removal of waste by dialysis, either via the blood (haemodialysis) or via the stomach area (peritoneal dialysis). 27,000 patients currently receive dialysis in the UK and some endure reduced quality-of-life, depression, and thinking and memory difficulties. Some of these symptoms reflect undiagnosed dementia. Indeed up to 7/10 dialysis patients suffer moderate to severe brain impairment or dementia - much more frequently than in the general population. This study will assess brain function just before starting dialysis/transplant and at 3 and 12 months afterwards with face to face assessments and with brain scans in some patients. Changes in brain function will be compared between people treated with the different forms of dialysis and transplant. The Investigators hope to evaluate whether these tests are acceptable to patients, whether affected sub-groups with cognitive impairment can be identified early, and if certain dialysis methods are better for patients with cognitive impairment/dementia, so that a larger study to try to improve brain function after RRT can be developed.

Conditions

Cognitive Impairment; Chronic Kidney Diseases; End Stage Renal Disease; Dementia; Hemodialysis Complication; Peritoneal Dialysis Complication; Renal Transplant

Keywords

cognitive impairment; hemodialysis; dementia; end stage renal disease

Outcome Measures

Primary Outcomes (1)

• To test the feasibility of performing serial detailed neurocognitive assessments in patients before during and after the period of commencing RRT for End-Stage Kidney Disease

  Number of patients eligible, no of patients consented, number of patients who underwent both baseline and longitudinal neurocognitive assessments

  2.5years

Secondary Outcomes (5)

• Estimate cross-sectional and longitudinal variability in a novel battery of neurocognitive assessments amongst participants in transition to all 3 modalities of RRT.

  2.5years

• Assess the administration, suitability and adherence of the chosen cognitive and quality of life measures in participants.

  2.5 years

• Test the feasibility of recruitment to a longitudinal brain magnetic resonance imaging (MRI) study in a randomly selected proportion of participants.

  18 months

• Estimate the cross-sectional and longitudinal variability in multiparametric brain MRI parameters and their interaction with cognitive functional change in this transitional population.

  2.5years

• To describe resource implications including patients referred to specialist services due to new diagnoses of cognitive impairment, dementia and/or depression

  2,5 years

Interventions

Cognitive Assessment PROCEDURE

Each patient with have a 2 hour cognitive assessment at baseline, 3months after starting renal replacement therapy and 12 months after starting renal replacement therapy

Depression and Quality of Life Assessment DIAGNOSTIC_TEST

Each patient with have a 2 hour depression and QOL assessment at baseline, 3months after starting renal replacement therapy and 12 months after starting renal replacement therpay

Eligibility Criteria

• Age: 55 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The target population is clinic based patients with advanced CKD who are due to commence RRT in the next 1-2 months as determined by the treating clinician. Patient screening, information giving and consenting for this feasibility study will be performed in the low clearance clinic at Salford (held twice per week). Enrolment of willing and eligible patients who are admitted into hospital to start RRT in the absence of infection and delirium may also be assessed.

You may qualify if:

• eGFR \<15/ml/min/1.73m2
• Aged 55 years and over
• Mental capacity to understand the study and give informed consent

You may not qualify if:

• Age \<55 years
• Non-English speaking
• Patients known to have a psychiatric condition, including severe depression, bipolar affective disorder, severe anxiety, panic disorder, substance misuse or psychosis or previous severe head injury
• Contraindications to magnetic resonance imaging
• Patients who have chosen not to undergo dialysis treatment (conservative care).

Sponsors & Collaborators

• Natalie Garratt: lead

Study Sites (1)

Salford Royal Nhs Foundation Trust

Salford, Greater Manchester, M6 8HD, United Kingdom

Location

MeSH Terms

Conditions

Cognitive Dysfunction; Renal Insufficiency, Chronic; Kidney Failure, Chronic; Dementia

Interventions

Mental Status and Dementia Tests

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Neuropsychological Tests; Psychological Tests; Behavioral Disciplines and Activities

Study Officials

• James Tollitt, MBcHB

  Northern Care Alliance NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Research Development Lead

Study Record Dates

• First Submitted: September 29, 2017
• First Posted: December 26, 2017
• Study Start: February 20, 2018
• Primary Completion: September 27, 2019
• Study Completion: September 27, 2019
• Last Updated: February 7, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)