Within the present project we aim for a structural evaluation and registration of multidimensional clinical and geriatric data in all older patients with CKD stage IV and V, who will progress to ESRD, as proposed in the above mentioned guidelines.…
ID
Source
Brief title
Condition
- Renal disorders (excl nephropathies)
- Age related factors
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Implementation of a care pathway for older patients with ESRD, including a
registry for future research to predict and improve outcomes for older patients
with ESRD. Primary endpoints are A) the number of patients successfully
included in the national data registry and B) the number of centers included in
the national consortium.
Secondary outcome
We aim to study the association of geriatric measures with treatment choices,
survival, hospital admissions and selected biomarkers after 1 year of follow
up, and aim to establish recommendations for further national implementation.
Besides, we investigate if the COVID-19 pandemic leads to decreased quality of
life, increased feelings of fear and depressive symptoms in patients nearing
end stage renal disease.
Background summary
The prevalence of End Stage Renal Disease (ESRD) increases with age, and is
associated with poor outcome, especially in older age. Although the benefits of
dialysis and/or kidney transplantation have been firmly established for most
patient groups, there is a subgroup of patients in whom serious adverse
outcomes occur, such as early mortality or accelerated functional and/or
cognitive decline. Such adverse events occur more frequently in the older
patient with ESRD, as increasing age by definition leads to increased
vulnerability and increased susceptibility for side effects of treatment.
Furthermore, preserving quality of life (QOL) and the desire to stay
independent as much as possible may outweigh longer survival in at least some
patients in this age group. However, the risk of poor outcome differs greatly
between older ESRD patients due to substantial heterogeneity with respect to
the presence of comorbidities and geriatric conditions, such as functional and
cognitive impairment and frailty. Despite the growing number of frail and older
patients with ESRD, there is a paucity of well-designed, prospective studies in
this population which limits the evidence for personalized approaches
supporting treatment decisions. A basic set of validated markers for
comorbidity, cognitive function, nutritional and functional status, assessed
before starting renal replacement therapy and with a regular follow up, will
identify vulnerable patients in a multidimensional approach. Establishing which
of these geriatric conditions independently associate with poor outcome and
loss of QOL, may ultimately help to better identify those patients at risk for
negative outcomes and thus guide informed treatment decisions or preventive
interventions.
The recent publications of the guidelines *Nierfunctievervangende Therapie* and
*Palliatieve Zorg bij Nierfalen* emphasize the importance of a multidimensional
approach to the frail patient with ESRD, by recommending the implementation of
geriatric assessment of older patients with ESRD when reaching end stage renal
disease. Based on the literature, experience from previous studies and focus
group interviews with patients and caregivers we designed a nephro-geriatric
assessment.
Study objective
Within the present project we aim for a structural evaluation and registration
of multidimensional clinical and geriatric data in all older patients with CKD
stage IV and V, who will progress to ESRD, as proposed in the above mentioned
guidelines. We will implement a care pathway including a systematic
nephro-geriatric assessment and set up a national multi-center registration of
geriatric patients who will reach ESRD in the Netherlands to investigate the
association of geriatric measures and biomarkers with negative outcomes.
Study design
Implementation study and observational, prospective cohort study.
Study burden and risks
Study specific burden consists of a taking blood sample at baseline and
systematic collection of outcome measures consisting both of routinely
collected clinical parameters and repeated collection of Patient reported
outcomes (PROM*s). The standardized nephrogeriatric assessment at baseline and
repeated geriatric assessments during follow-up are part of routine clinical
care as outlined in the recent guidelines *Nierfunctievervangende Therapie* and
*Palliatieve Zorg bij Nierfalen*.
Albinusdreef 2
Leiden 2333ZA
NL
Albinusdreef 2
Leiden 2333ZA
NL
Listed location countries
Age
Inclusion criteria
Dutch speaking
* 70 years of age
end stage renal disease (eGFR * 20 ml/min/1.73 m2 (based on CKD-EPI))
Exclusion criteria
Illiterate
Unable to give informed consent
Design
Recruitment
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
metc-ldd@lumc.nl
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
In other registers
Register | ID |
---|---|
CCMO | NL65322.098.18 |
Other | NL7104 (NTR7310) |
OMON | NL-OMON20312 |