Re-examining Nutrition in Dialysis Patients: Nutritional Losses and the Role of Supplementation (Part 2).
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 114
- 试验地点
- 2
- 主要终点
- To identify how protein intake and supplements influence patients' unplanned hospitalisation rate.
研究概览
简要总结
When a patient has dialysis some nutrients are lost in the process. Nutritional losses include protein, trace elements (i.e. zinc, copper and selenium) and water-soluble vitamins (Vitamins C and B). These nutrients are essential for normal body function, including a good immune system and nutritional status. For example, on average the protein losses during a dialysis session (the process where the blood is cleaned via a machine and special fluid) is equal to 6g of protein/day (which is the equivalent of the amount of protein in 1 egg). Protein needs for the general population are 0.8g protein per kg of body weight. Because people on dialysis lose protein via the dialysis, it is thought that these people need to eat more protein. Currently, in clinical practice for people receiving dialysis, the guidelines are to aim for 1.1 -1.4g of protein per kg of body weight. However, the research is old and very weak.
Dialysis treatments have changed over the past 40 years, and the investigator does not know if the replacement of these nutritional losses is important to how well people do on dialysis and if they have any effect on survival. Previous research is mostly limited to haemodialysis (a type of dialysis that requires a machine which cleans the patients' blood via special filters) and peritoneal dialysis (this is a type of dialysis which happens via the patients' tummy). There is no research on the nutritional supplementation in home HD and nocturnal HD. Our research will investigate if a higher protein provision leads to a reduction is hospital admissions and improved outcomes in patients receiving dialysis.
详细描述
Malnutrition, specifically protein-energy wasting (PEW), is a major independent risk factor for poor quality of life and premature death in patients receiving dialysis.
Nutritional losses occur in patients on dialysis and have been documented over 40 years . Nutritional losses include nitrogen (amino acids, small peptides, proteins), trace elements (i.e. zinc, copper and selenium) and water-soluble vitamins (i.e. B vitamins and vitamin C). Dialysis membranes and modalities have changed over the past 40 years, and the investigators do not know if these nutritional losses (and their replacement) are of clinical significance to patients' clinical outcomes. In addition, research on this topic has focused on in-centre haemodialysis (ICHD), and, to a lesser extent, on peritoneal dialysis (PD). There are no studies reporting nutritional losses in patients receiving HD at home (HHD) and nocturnal HD (NHD) where different technologies and scheduling are often utilised. Nutritional losses could be different for different dialysis modalities. While there has been a lot of observational cohort data looking at different levels of protein intake, no long-term interventional studies have been conducted.
Funding was successfully obtained by Kidney Research UK to conduct two studies:
- Phase one, which is currently ongoing (IRAS 320440), aims to measure nutritional losses in people receiving maintenance dialysis, in different dialysis modalities.
- Phase two, this study (IRAS 343782), is a pragmatic pilot interventional study which will assess the impact of different protein intakes on patients' clinical outcomes in people on maintenance dialysis.
Dialysis techniques and modalities have changed significantly over the past 20 years. Yet current guidelines for protein provision are based on out-of-date data. Clinical guidelines for protein provision in ICHD and PD have not changed significantly in the past 20 years. There are no guidelines for HHD and NHD, as there is no evidence.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 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
- •Age ≥ 18 years (no upper age limit)
- •Patients receiving maintenance dialysis for ≥ three months
- •Ability to provide informed consent
排除标准
- •Anticipated live donor kidney transplant and/or kidney recovery within the period of sample collection.
- •Anticipated change of dialysis modality within the period of sample collection
- •Severe malnutrition based on either:
- •Renal 7-point Subjective Global Assessment (SGA) scores of 1-2
- •Global Leadership Initiative Malnutrition (GLIM) Stage 2
- •Protein-losing enteropathy.
- •Persistent nephrotic syndrome with >3g/day urinary protein loss.
- •Active wounds or burns contributing to protein losses as judged by the investigator.
- •Current active acute inflammatory illness (likely to have catabolic effect in the opinion of the investigator).
- •Current malignancy based on recent (<12 months) diagnosis and/or active treatment for malignancy and/or planned treatment for malignancy, excluding non-melanoma skin cancers.
- •Pregnancy (current or planned within duration of study) or breast feeding.
- •People with swallowing difficulties precluding safe ingestion (International Dysphagia Diet Standardization Initiative (IDDSI) level 0 thin fluid).
- •People receiving intradialytic parenteral nutrition or intra-peritoneal amino acids, or any other forms of artificial feeding
- •People prescribed levodopa
- •People who are receiving chronic glucocorticoid therapy (>10mg day prednisolone or equivalent for >7 days within preceding 90 days).
- •People who are consuming a protein dietary intake above 1.5g protein/kg/body weight.
- •People who, in the opinion of the investigator, will be unable to comply with study protocol requirements.
- •People who are vegan or other religious based dietary restrictions which would prevent them taking the supplement.
结局指标
主要结局
To identify how protein intake and supplements influence patients' unplanned hospitalisation rate.
时间窗: 2 years
Purpose To measure the impact of different amounts of protein intake (protein in the diet) on clinical outcomes (including unplanned hospital admissions) in patients receiving the different dialysis modalities (ICHD, HHD, NHD and PD). The investigators hypothesis is that a modality-specific and high-protein supplementation regimen reduces unplanned hospitalisation rate in patients receiving dialysis (ICHD, PD, HD, NHD) compared with those without supplementation.
次要结局
- To assess association between protein intake and patients related outcomes measures.(2 years)