Protecting Kidneys Through a Low Protein Diet: A Stepwise Multiple-Choice System Approach
- Conditions
- Chronic Kidney Diseases
- Interventions
- Other: low protein diet
- Registration Number
- NCT03979534
- Lead Sponsor
- Centre Hospitalier le Mans
- Brief Summary
Nephrology care continues to progress and recommendations are now focused on delaying as much as possible the need for renal replacement therapy ("intent-to-defer"strategy). Protein restriction is a valuable tool for stabilizing chronic kidney disease (CKD) and retarding the need for renal replacement therapy, but the best diet to be prescribed is still matter of discussion. This study is aimed at identifying implementation strategies for nutritional management of advanced CKD.
- Detailed Description
The recent paradigm on dialysis start suggests that an intention to defer policy should be preferred to beginning dialysis early ("the earliest the best" strategy). This strategy is further supported by the consideration that patient profiles are changing with the increasing proportion of older and higher comorbidity patients. In high comorbidity patients, survival is not necessarily improved by dialysis.
Nutritional care, adapted to each patient's needs and preferences, could in part answer these demands. Indeed, renal function has a strict correlation with dietary patterns. Low protein diets may have two favourable effects: 1) slowing down kidney function decline and 2) delaying the need of replacement therapy (metabolic stabilizing). In dialysis, the nutritional state is the most important survival indicator, and nutritional follow-up should allow starting dialysis in a good nutritional status.
The study proposed here is an implementation study with a principal aim to improve the use of low protein diets in the clinical setting, by offering a multiple choice approach and by adapting the diets to the patients' needs.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 100
- All adult patients followed on the unit for advanced CKD, with Kidney disease stage 4-5 or stage 3 with fast progression and without contraindications.
- Malnutrition or short life-expectancy
- Patients aged less than 18 years old
- Pregnant women,
- Incapacity to complete the free-consent form,
- Pateints refusing participation in the study,
- Patients without healthcare coverage.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Diet group low protein diet Diet follow-up to personalize a low-protein diet for each patient. All patients following a low protein diet one month or more compose the "diet group".
- Primary Outcome Measures
Name Time Method Adherence to the multiple-choice diet program 4 years Percentage of patients who drop-out of the multiple choice diet program
- Secondary Outcome Measures
Name Time Method Patient survival 4 years The patient survival compared to reference data (from the Réseau Epidemiologie, Information, Néphrologie) and international registers.
Cost of the treatment 4 years Cost of the treatment, including diet, renal replacement therapy and pharmacological interventions.
Patients included in a home dialysis program 4 years Percentage of patients without contraindications who started a home dialysis treatment
Kidney survival 4 years The "kidney survival" from the beginning of the diet to the start of renal replacement therapy
Patients included in an incremental dialysis program. 4 years Percentage of patients without contraindications who started dialysis with an incremental schedule.
Patients included in a transplantation program 4 years Percentage of patients without contraindications enrolled on the pre-emptive kidney transplant list.
Trial Locations
- Locations (1)
Centre Hospitalier Le Mans
🇫🇷Le Mans, France