Incremental Haemodialysis
Conditions
Keywords
ketosteril, incremental haemodialysis
Brief summary
Previous studies suggest that the supplementation of essential amino acids and ketaoacids may prolong the duration of the incremental phase of peritoneal dialysis. There is no data on incremental haemodialysis patients. Such data would be highly needed to support the management of haemodialysis patients in the transition phase from "pre-dialysis" to "full dose" dialysis. In this context, investigator proposed a randomized "add on" trial, to evaluate the effect of the addition of Ketosteril to the usual nutritional plan to patients who start haemodialysis in incremental way.
Interventions
DRUGSupplementation by ketosteril
1 tablet each 10 kg of ideal Body Weight is dispensed per day
Sponsors
Centre Hospitalier le Mans
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adult patients (aged 18 years or older) * Able and accepting to give informed consent * Starting iHD in the Centre Hospitalier Le Mans
Exclusion criteria
* Denying informed consent * Acute kidney injury (AKI) * Life expectancy of less than 3 months, or kidney transplantation scheduled within 3 months * Cognitive impairment severe enough to limit understanding and acceptance of the study * Impossibility to regain kidney function (bilateral nephrectomy, documented irreversible complete destruction of the kidney tissue) * Patient with genetic disease affecting amino acid metabolism * Hypercalcemia defined as calcemia beyond the upper limit of normality according to the laboratory where the test is performed and persisting for at least one month * Hypersensitivity to the active substances or to any of the excipients of Ketosteril * Non-compliance to dialysis prescription * Previous enrolment in a randomized study using Ketosteril * Currently enrolled in another interventional clinical trial * Protected by law (patient under guardianship, minor, prisoner, pregnant or breastfeeding woman, …)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Duration of incremental haemodialysis period | 24 months | Duration in months of the incremental haemodialysis period (defined as less than 3 times per week but excluding the cases in which dialysis frequency is reduced in the context of palliative and end-of life care) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Mortality | 24 months | Number of patients who have died (patients who discontinue dialysis in the context of an "end of life care project" are considered as deceased at the start of the program of palliative care) |
| Hospitalization rates | 24 months | Hospitalization rates (all causes), excluding the hospitalization at dialysis start and hospitalization for end-of-life care. |
| Combined outcome mortality and hospitalization | 24 months | — |
| Quality of life | 24 months | Quality of life is assessed by questionnaire WHO QoL (from 26 to 130, the higher the score, the better the quality of life) |
| Nutritional status | 24 months | Nutritional status will be assessed by evaluation of body composition by Bioelectrical Impedance Analysis (BIA). |
| Costs | 24 months | Costs related to incremental Haemodialysis and Ketosteril, with respect to costs of standard Haemodialysis |
| Water saving | 24 months | Savings in terms of water (m\^3) will be calculated based on the number of spared hemodialysis sessions compared to a standard schedule three times/week hemodialysis |
| Perceived diet quality | 24 months | Perceived diet quality is assessed by questionnaire MDRD (Modification of Diet in Renal Disease, the higher the score, the more satisfied the patient is with their diet) |
| Energy savings | 24 months | Savings in terms of energy (kW/h) will be calculated based on the number of spared hemodialysis sessions compared to a standard schedule three times/week hemodialysis |
| Waste Management | 24 months | Savings in terms of waste (kg) will be calculated based on the number of spared hemodialysis sessions compared to a standard schedule three times/week hemodialysis |
| Assessment of Appetite | 24 months | Appetite is assessed by council on nutrition appetite questionnaire (A CNAQ score of 28 or less indicates a significant risk of weight loss of at least 5% within six months) |
Countries
France
Contacts
CONTACTChristelle JADEAU, MD
CONTACTMassimo TORREGGIANI, MD
Outcome results
None listed