Combined Dietary Intervention in Hyperkalemic CKD Patients With Potassium Binder (With Hyperkalemia) (DiPo Trial)
试验速览
- 阶段
- 1 期
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Normalization of Serum Potassium level
研究概览
简要总结
This study hypothesizes that the administration of Sodium zirconium cyclosilicate in CKD patients with hyperkalemia while avoiding dietary potassium restriction will normalize their serum potassium levels. Additionally, we aim to assess the effects of a high potassium diet on renal function, endothelial function, acidosis, systemic inflammatory status and gut microbiota.
详细描述
A diet rich in fruits and vegetables is associated with better outcomes in CKD patients. However, the presence of hyperkalemia can prevent patients from increasing plant-based foods in their diets. While hyperkalemia can have severe health consequences in advanced CKD, the decreased consumption of plant-based foods can be associated with adverse health outcomes in this population.
Sodium zirconium cyclosilicate (SZC) is a non-absorbed cation exchanger that selectively binds potassium in the intestine.
This study plans to enroll CKD patients with an eGFR ≤45mL/min and a serum potassium ≥ 5mEq/L, administering SZC to achieve normokalemia, and provide them with a diet rich in fruits and vegetables. Endothelial function, inflammatory biomarkers and stool microbiota will be measured to assess the potential benefits of providing a diet rich in fruits and vegetables, albeit rich in potassium, in advanced CKD patients. Because these patients are usually restricting the intake of plant-based proteins and foods due to the concerns of hyperkalemia, eliminating this serious and potentially-life threatening clinical condition might carry health benefits, such as improved endothelial function and decreased inflammation
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women over the age of 18
- •CKD stage 3-4 with an estimated GFR less or equal to 45 mL/min but greater than 15 mL/min
- •Serum potassium level ≥5 mEq/L on two blood tests in the past 3 months but less than 6.5mEq/L
排除标准
- •On dialysis
- •Have been on SZC in the past 3 months
- •Reside in a nursing home
- •Pregnant patients
- •Patients with known cognitive disability
- •History of bowel disease such as but not limited to short bowel syndrome, bowel obstruction, inflammatory bowel disease
研究组 & 干预措施
Intervention
All 20 CKD patients will be receiving a potassium binder while consuming a tailored diet of non-potassium restricted foods
干预措施: Sodium Zirconium Cyclosilicate Oral Product (Drug)
结局指标
主要结局
Normalization of Serum Potassium level
时间窗: 2 days
Achieve a serum potassium level less than 5mEq/L
次要结局
- Change in Acidosis (serum HCO3 levels)(15 days)
- Change in Endothelial function(15 days)
- Systematic inflammatory status using serum biomarkers(15 days)
- Changes in gut microbiota using stool collections(15 days)
研究者
Lea Borgi
Associate Program Director, BWH/MGH Nephrology Fellowship Program Associate Physician, Renal Division, Brigham and Women's Hospital Instructor in Medicine, Harvard Medical School
Brigham and Women's Hospital