Exploring the Effectiveness and Safety of Amino Acid Peritoneal Dialysis Solution in Improving Nutritional Status in Maintenance Peritoneal Dialysis Patients: a Multicenter, Open, Prospective, Self Controlled Clinical Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 149
- 试验地点
- 1
- 主要终点
- Blood Albumin
研究概览
简要总结
This study adopts a multicenter, open, prospective, and self controlled study design, in which each participant serves as their own control before and after receiving amino acid peritoneal dialysis solution treatment to compare changes in their nutritional status. Each subject received treatment with 1 bag of amino acid peritoneal dialysis per day and 2-4 bags of glucose peritoneal dialysis solution per day for 6 months (the amount of glucose peritoneal dialysis solution used was determined based on the treatment plan selected by the patient during the screening period when they entered the study).Before treatment and during the 3rd and 6th months of treatment, subjects were evaluated for various efficacy and safety indicators, and any adverse or serious adverse events were recorded.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •For uremic patients with malnutrition during the screening period, maintenance peritoneal dialysis should be performed for at least 3 months. The standard for malnutrition should meet at least two of the following items: (1) serum albumin level<3.5g/dL (35g/L), (2) prealbumin<300mg/L, (3) modifiedSubjective Global Assessment (SGA) with a score of>7;
- •Blood urea nitrogen ≤ 38mmol/L;
- •The patient's age is between 18 and 75 years old;
- •The patient signs an informed consent form.
排除标准
- •Individuals who are allergic to any amino acids or excipients in this product
- •More than one occurrence of peritonitis in the past three months; Peritonitis or hospitalization within the past month;
- •Patients with hyperthyroidism, systemic infection, fever, and other high catabolic metabolic diseases, as well as those who are taking drugs that affect tissue metabolism, such as corticosteroids;
- •Congenital amino acid metabolism deficiency disease, acute severe pancreatitis, severe hyperbilirubinemia
- •Patients with malignant tumor metastasis or spread, residual cancer after treatment, coagulation dysfunction, aplastic anemia, heart, brain, lung and other serious system diseases;
- •Possible kidney transplantation during the trial period;
- •Active phase of hepatitis B or C, liver cirrhosis, active liver disease, liver dysfunction, or positive serum reaction of human immunodeficiency virus (HIV);
- •Those who have participated in clinical trials of other drugs within the three months prior to enrollment;
- •Pregnant and lactating women;
- •Those who are mentally unable to cooperate;
- •Failure to sign a written informed consent form;
- •Unable or unwilling to comply with the experimental protocol approved by the researcher.
研究组 & 干预措施
Self Control
Compare the nutritional and safety indicators of the subjects before treatment and during the third and sixth months of treatment.
干预措施: Amino acid peritoneal dialysis solution (Drug)
结局指标
主要结局
Blood Albumin
时间窗: 6 months
Changes in blood albumin levels
Prealbumin
时间窗: 6 months
Changes in blood prealbumin levels
次要结局
未报告次要终点
研究者
deng shanshan
Researcher
The People's Hospital of Gaozhou