Knowledge on the magnitude of the decline and the pathophysiological mechanism can eventually help us topostulate an algorithm for well-balanced decision making in treatment strategies in the elderly CKD patients.This knowledge will be firmly…
ID
Source
Brief title
Condition
- Renal disorders (excl nephropathies)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Our primary analysis will be to calculate the mean change in MMSE score and
cognitive test battery (Stroop, Letter Digit Coding Test and Picture Learning,
Immediate and Delayed) after initiation of RRT.
To determine whether this change in cognitive function is attributable to the
initiation of RRT, we will compare these change to
1) change in MMSE score and cognitive and functional test battery in those
older patients who did not initiate RRT in two consecutive years (n=200),
2) change in MMSE score and cognitive and functional test battery in the
individuals who did initiate RRT in two consecutive years prior to start of RRT.
3) the association between the change in MMSE score and cognitive and
functional test battery after initiation of RRT with various parameters of
brain structure (measures of vascular cognitive impairment) or perfusion
(measures of auto-regulation) at baseline.
Secondary outcome
Our secondary analysis will be:
1) to evaluate the correlation between the results of CGA and cognitive test
battery and cardiovascular markers and disease, metabolic parameters, and (the
rate of decline) of eGFR.
2) Correlation between outcome of CGA and the impact of disease on quality of
life.
Background summary
Patients with End Stage Renal Disease (ESRD) who initiate haemodialysis are at
risk for cognitive decline,
but the magnitude of the decline and the pathophysiological mechanism is
largely unknown. There is a rising
influx of elderly patients with ESRD starting with renal hemodialysis in the
last decade and their number will
continue to increase. Both cognitive impairment and higher age are risk factors
for poor outcome in patients
on hemodialysis. Furthermore, such cognitive function should be assessed in the
context of overall
functioning, which in older patients is usually assessed using a comprehensive
geriatric assessment (CGA).
Overall changes in co-morbidity, frailty and functioning may contribute to
cognitive decline and should
therefore be assessed in parallel.
Brain perfusion plays an important role in cognitive function. Several
processes which are highly prevalent
among older patients with ESRD, such as chronic hypertension, stroke and
atherosclerosis, influence
cerebral auto-regulation. It is therefore conceivable that there is a
concomitant disturbance of cerebral autoregulation,
resulting in disturbances in brain perfusion and structural changes, finally
leading to cognitive
decline.
We hypothesize that auto-regulation of brain perfusion is disturbed in older
patients with ESRD and that
initiation of hemodialysis results in decreased brain perfusion by disturbing
hemodynamics. We also
hypothesize that this dysregulation contributes to the cognitive decline in
these patients.
The overall aim of the present project is therefore to quantify the rate of
cognitive decline in
in older patients with end stage renal disease who initiate hemodialysis and
assess whether the rate
of cognitive decline can be explained by disturbances of brain perfusion.
In this prospective cohort study we will include and follow older (65-plus
years) patients with ESRD in predialysis
outpatient clinics. We will administer a CGA to quantify the cognitive function
using a standardized
cognitive test battery and overall functioning as well as MRI scans of the
brain including brain structure and
perfusion. All participants will be followed annually, including 6 months after
initiation of hemodialysis. We
target to include 100 new hemodialysis patients and assess 1) the rate of
cognitive decline after initiation of
hemodialysis, 2) the effect of hemodialysis on brain perfusion, and 3) the
association between cognitive
decline and initial disturbances in brain structure or perfusion.
Study objective
Knowledge on the magnitude of the decline and the pathophysiological mechanism
can eventually help us to
postulate an algorithm for well-balanced decision making in treatment
strategies in the elderly CKD patients.
This knowledge will be firmly embedded and implemented in our new out-patient
clinic for older patients with
ESRD.
Study design
observational, multicenter
Study burden and risks
limited burden involved
1. totale time investment is limited (regular out-patient visits
2. No risks (observational investigation)
Albinusdreef 2
Leiden 2333 ZA
NL
Albinusdreef 2
Leiden 2333 ZA
NL
Listed location countries
Age
Inclusion criteria
> 65 years of age with eGFR < 20 ml/min during the past 6 months.
Exclusion criteria
Illiterat
foreign language
Unable to give informed consent
Design
Recruitment
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
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In other registers
Register | ID |
---|---|
CCMO | NL46389.058.13 |