Clinical trial NCT03782519: Quality of Life of Frail Aged Patients in Incremental Hemodialysis
Official title: Quality of Life of Frail Aged Patients in Incremental Hemodialysis: a Phase III Study
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Renal Dialysis
Kidney Failure, Chronic
Frailty
Keywords: Incremental Hemodialysis
Nephrology
Lead sponsor: Centre Hospitalier Universitaire de Besancon
Sponsor class: OTHER
First posted: 2018-12-20
Enrollment: 783
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: End stage renal disease (ESRD) is a major public health problem. The dialysis population is aging. As a result we observe a high prevalence of frailty among dialysis patients (ranges from 3 to 10 fold higher than in the comparably aged general public). Frailty is a medical syndrome characterized by diminished strength, endurance, and reduced physiologic function that increases an individual's vulnerability for developing increased dependency and/or death. Without systematic approach it is difficult for physicians to detect frailty phenotype which however might be reversible or attenuated by interventions. Fried et al. developed a frailty phenotype consisting of 3 or more of: unintentional weight loss, exhaustion, physical inactivity, slow gait speed, and weak grip strength. The primary care of hemodialysis patient is often supported by the nephrologist. Identification of frailty is integrated into the primary care setting as one of the steps necessary for the overall assessment of the person and planning to formal prevention interventions in an individualized care plan. Thrice-weekly hemodialysis (HD) schedules are the standard default hemodialysis prescription in Western countries, imposed in the 70s. For incremental HD, the weekly dose of dialysis is based on variety of clinical factors such as residual kidney function, volume status, cardiovascular symptoms, potassium level, nutritional status and, comorbid conditions. Incremental HD scheme generally starts with 2 weekly sessions and then periodic monitoring of criteria mentioned above are used to determine the timing for increasing dialysis dose and frequency to 3 weekly sessions.

An approach that integrates systematic frailty phenotype assessment by nephrologists and individualized incremental HD therapy can be beneficial within the first year of HD. It could optimize health-related quality of life and other pertinent outcomes without affecting negatively the quality of dialysis. The purpose of this study is to evaluate for frail aged incidents hemodialysis patients the impact of implementation of an incremental HD on HRQoL compared to conventional HD.


Eligibility criteria: Inclusion Criteria:

For all patients (incident HD patients):

* Patient aged over 60 years
* Signature of informed consent
* Affiliation to a French social security or receiving such a scheme
* Patient with Chronic Kidney Disease Stage 5 (GFR \<15 ml/min/1.73m2)
* Urine output \> 0,5 L per day
* Kru ≥ 2 ml/min
* Outpatient with scheduled start of HD
* Understand and read french

For randomized patients (frail incident HD patients):

- Frailty according to L. Fried criteria: score greater than or equal to 3/5

Exclusion Criteria:

* Inability to understand the reasons for the study; psychiatric disorders
* Active and/or treated neoplastic disease
* Scheduled kidney transplantation within 6 months
* Solid organ transplanted patient receiving immunosuppressive therapy
* Estimated life expectancy \< 6 months
* Patient with diagnosis of severe chronic heart failure (\> 2 congestive heart failure episodes requiring hospitalization in the year preceding the start of HD)
* Legal disability or limited legal capacity
* Patient without health insurance
* Pregnant
* Patient in the period of exclusion of another study
* Uncooperative patient

Primary outcomes:
measure: Mental and physical health summary scores of the Medical Outcome Study - Short Form 36 (MOS SF-36)
timeFrame: One year after the initiation of HD
measure: Symptom/problem, effects of kidney disease and burden of kidney disease dimensions of the Kidney Disease Quality of Life (KDQOL)
timeFrame: One year after the initiation of HD
Secondary outcomes:
Other outcomes:
Locations:
city: Besançon
country: France
facility: Centre Hospitalier Universitaire de Besançon
Study officials:
affiliation: Nephrology, Dialysis and Renal Transplantation - CHU Besançon
name: Cécile Courivaud, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Fiteni F, Pam A, Anota A, Vernerey D, Paget-Bailly S, Westeel V, Bonnetain F. Health-related quality-of-life as co-primary endpoint in randomized clinical trials in oncology. Expert Rev Anticancer Ther. 2015;15(8):885-91. doi: 10.1586/14737140.2015.1047768. Epub 2015 May 31.