Protecting Kidneys Through a Low Protein Diet: A Stepwise Multiple-Choice System Approach (ProReRePro)

Centre Hospitalier le Mans

Status: Unknown

Conditions: Chronic Kidney Diseases

Treatments: Other: low protein diet

Study type: Interventional

Funder types: Other

Identifiers

NCT03979534

CHM-2016-S8/05

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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.

Trial design

Primary purpose: Other

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 2 patient groups

Diet group

Experimental group

Description:

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".

Treatment:

Other: low protein diet

Control group

No Intervention group

Description:

Patients who accepted to take part of the study but refused the low protein diet and patients who discontinued the diet on the first month compose the control group.