Protecting Kidneys Through a Low Protein Diet: A Stepwise Multiple-Choice System Approach
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Adherence to the multiple-choice diet program
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Control group
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.
Diet group
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".
干预措施: low protein diet (Other)
结局指标
主要结局
Adherence to the multiple-choice diet program
时间窗: 4 years
Percentage of patients who drop-out of the multiple choice diet program
次要结局
- Cost of the treatment(4 years)
- Patient survival(4 years)
- Patients included in a home dialysis program(4 years)
- Kidney survival(4 years)
- Patients included in an incremental dialysis program.(4 years)
- Patients included in a transplantation program(4 years)