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| ID | Type | Description | Link |
|---|---|---|---|
| 2025-524093-41-00 | EU Trial (CTIS) Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control arm | No Intervention | Current dietary management, without Ketosteril | |
| Interventional arm | Experimental | Current dietary management with supplementation by Ketosteril |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Supplementation by ketosteril | Drug | 1 tablet each 10 kg of ideal Body Weight is dispensed per day |
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| Measure | Description | Time Frame |
|---|---|---|
| Duration of incremental haemodialysis period | 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) | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| Mortality | 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) | 24 months |
| Hospitalization rates |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Christelle JADEAU, MD | Contact | 0244710781 | +33 | cjadeau@ch-lemans.fr |
| Massimo TORREGGIANI, MD | Contact | 02 53 04 04 70 | +33 | mtorreggiani@ch-lemans.fr |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Hospitalier Le Mans | Le Mans | 72000 | France |
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Hospitalization rates (all causes), excluding the hospitalization at dialysis start and hospitalization for end-of-life care.
| 24 months |
| Combined outcome mortality and hospitalization | 24 months |
| Quality of life | Quality of life is assessed by questionnaire WHO QoL (from 26 to 130, the higher the score, the better the quality of life) | 24 months |
| Nutritional status | Nutritional status will be assessed by evaluation of body composition by Bioelectrical Impedance Analysis (BIA). | 24 months |
| Costs | Costs related to incremental Haemodialysis and Ketosteril, with respect to costs of standard Haemodialysis | 24 months |
| Water saving | 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 | 24 months |
| Perceived diet quality | 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) | 24 months |
| Energy savings | 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 | 24 months |
| Waste Management | 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 | 24 months |
| Assessment of Appetite | 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) | 24 months |