The Role of Sodium Bicarbonate Enema in Improving Constipation and Reducing Uremic Toxins in Chronic Kidney Disease Patients.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 100
- 主要终点
- uremic toxins level
研究概览
简要总结
Chronic kidney disease (CKD) is a progressive condition characterized by a gradual loss of kidney function, often resulting in the accumulation of metabolic waste products. One of the emerging areas of interest in CKD management is the gut-kidney axis, which highlights the interplay between gut microbiota and renal health. CKD patients frequently exhibit gut dysbiosis and increased production of gut-derived uremic toxins such as indoxyl sulfate and p-cresyl sulfate, which can further exacerbate kidney damage and systemic inflammation.
CKD causes acidosis because damaged kidneys can't effectively excrete acids from the body or produce enough bicarbonate to neutralize them. This imbalance leads to a buildup of acids in the blood, resulting in metabolic acidosis, where acid levels in the blood become greater than normal.
Recent evidence suggests a close association between constipation and clinical outcomes such as cardiovascular disease, CKD progression and mortality(1-4). In particular, numerous observational studies have reported a higher prevalence of constipation in patients with CKD. Although the global prevalence of constipation in the general population has been estimated at approximately 14%, the prevalence in patients with CKD is reported to be much higher(5). A recent meta analysis reported a constipation prevalence of 38.8% in patients with advanced non-dialysis CKD(6). Patients with end-stage renal disease (ESRD) have been shown to have a substantially higher constipation prevalence, with some studies reporting over 50%(7).
This study focuses on using the GIT as an additional excretory pathway of the uremic toxins via using sodium bicarbonate enema in patients with CKD.
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 60 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •- Adults aged 18-60 years
- •Diagnosed with CKD stage 3-4
- •Stable renal function for 3 months
- •Able to give informed consent
排除标准
- •- Active GI disease (IBD, colon cancer, severe hemorrhoids, anal fissure)
- •Recent abdominal or colorectal surgery
- •Severe cardiovascular conditions
- •Pregnancy or breastfeeding
- •Electrolyte imbalance
研究组 & 干预措施
study group
patients with CKD will recived sodium bicarbonate enema
干预措施: sodium bicarbonate enema (Procedure)
结局指标
主要结局
uremic toxins level
时间窗: 3 months
uremic toxins level after sodium bicarbonate enema
次要结局
未报告次要终点
研究者
Mohamed Ali Goubara Abdulhaq
residant doctor at Assiut university hospital
Assiut University
