Study of a Dialysate Without Acetate on Protein Energy Wasting Syndrome in Chronic Hemodialysis Patient
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- prealbumin
研究概览
简要总结
This work aims to study the effect of an acetate-free dialysate on protein-energy wasting syndrome in patients with chronic hemodialysis renal failure, in comparison to a conventional dialysate with acetate. The hypothesis is that a dialysate without acetate would improve patients nutritional status
详细描述
The dialysate usually used at the Clermont Ferrand CHU dialysis center is a dialysate containing acetate After inclusion, patients will be randomly divided into two groups. Patients in group 1 will first be treated with the acetate-free dialysate (A-D) for 6 months and then the acetate-containing dialysate (A + D) for 6 months. Group 2 patients will continue on the usual dialysate (A + D) for 6 months and then switch to A-D dialysate for the next 6 months. Patients will be blinded from study treatment.
Patients will be followed for 1 year.
A the beginning then every 3 months will be carried out:
- A measurement of body composition by multi-frequency bioimpedancemetry
- A measurement of the gripping force by a dynamometer (hand grip force )
- A 4-meter walk test
- A SARC-F Sarcopenia Assessment Questionnaire A blood test for the usual biological analyzes carried out as part of the recommendations for monitoring patients on hemodialysis will be carried out every month.
An additional blood sample (5.5 mL) for quantification of the levels of expression of potential blood biomarkers of muscle condition will be taken initially, at 6 months and at 12 months (i.e. 16.5 mL more compared to current practice). ).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Participant)
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
- •Major patient;
- •Man or woman ;
- •Treated with intermittent hemodialysis for chronic renal failure;
- •Affiliated with a social security scheme;
- •Having given a signed agreement after detailed explanation of the protocol on the basis of the information sheet and likely to comply with it
排除标准
- •Patient with lower limb amputation more proximal than a transmetatarsal amputation (invalidity of the model for estimating body composition by BCM in this situation)
- •Acute event in the 3 months preceding inclusion (infection, surgery).
- •Having a neuromuscular pathology responsible for a motor deficit.
- •Whose life expectancy does not exceed 6 months
- •With a psychiatric pathology or cognitive impairment rendering him unable to give informed consent
- •Pregnant women
- •Patient under guardianship, curatorship or legal protection
研究组 & 干预措施
Acetate free then acetate containing dialysate
Patients in group 1 will first be treated with the acetate-free dialysate (A-D) for 6 months and then the acetate-containing dialysate (A + D) for 6 months.
干预措施: Chlorhydric acid based acid concentrate for bicarbonate hemodialysis (medical device) (Device)
Acetate containing dialysate then acetate free dialysate
Group 2 patients will continue on the usual dialysate (A + D) for 6 months and then switch to A-D dialysate for the next 6 months. Patients will be blinded from study treatment.
干预措施: Chlorhydric acid based acid concentrate for bicarbonate hemodialysis (medical device) (Device)
结局指标
主要结局
prealbumin
时间窗: change at 6 months from the start of Acetate free or acetate containing dialysate
biochemical measurement
次要结局
- muscle biomarkers(Year 1)
- mortality(Year 1)
- morbidity(Year 1)
- SARC-F(change at 6 months from the start of acetate free or acetate containing dialysate)
- Muscle mass(change at 6 months from the start of acetate free or acetate containing dialysate)
- Muscle performance(change at 6 months from the start of acetate free or acetate containing dialysate)
- Muscle performance with hand grip test(change at 6 months from the start of acetate free or acetate containing dialysate)
- muscle biomarkers(Month 6)