Quality of Life of Frail Aged Patients in Incremental Hemodialysis (Qualifragilys)

Centre Hospitalier Universitaire de Besancon

Status: Unknown

Conditions: Frailty; Renal Dialysis; Kidney Failure, Chronic

Treatments: Other: Frailty diagnosis; Other: Dialysis frequency reduction

Study type: Interventional

Funder types: Other

Identifiers

NCT03782519

N/2016/75

Details and patient eligibility

About

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.

Enrollment: 783 estimated patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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783 participants in 2 patient groups

Incremental hemodialysis

Experimental group

Description:

Patients who will begin HD with two treatment sessions per week

Treatment:

Other: Dialysis frequency reduction

Other: Frailty diagnosis

Conventional hemodialysis

Active Comparator group

Description:

Patients who will begin HD three times a week

Treatment:

Other: Frailty diagnosis