Effect of lower vs higher serum bicarbonate targets with oral bicarbonate therapy on kidney disease progression in chronic kidney disease: A randomized controlled trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 148
- 试验地点
- 1
- 主要终点
- Change in estimated glomerular filtration rate between the groups.
研究概览
简要总结
This randomized controlled trial will examine whether maintaining a higher serum bicarbonate target (24 to 28 millimol per litre) versus a lower target (20 to 24 millimol per litre) using oral sodium bicarbonate slows chronic kidney disease (CKD) progression. Adults more than or equal to 18 years with CKD stages 3 to 5 and serum bicarbonate less than 18 millimol per litre will be randomized in a 1:1 ratio using opaque sealed envelopes for allocation concealment. The higher target group receives 0.5 mEq per kg of lean body weight per day, and the lower target group 0.25 mEq per kg of lean body weight per day, titrated to targets. The primary outcome is eGFR change over 12 months, and secondary outcomes include muscle mass, strength, nutrition, blood pressure, and hyperkalemia in 148 participants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •Adults more than 18 years of age Serum bicarbonate level of less than 18 millimol per litre.
- •CKD patients stage 3 to 5.
排除标准
- •Patients who are on dialysis or with a history of transplantation.
- •History of advanced heart failure (NYHA Class III and IV) or significant left ventricular dysfunction (ejection fraction less than 40 percent) Patients with structural and functional anomalies of the gastrointestinal tract, chronic liver disease, active malignancies, and chronic infections.
- •Uncontrolled hypertension more than 160/100 mmHg. Morbid obesity (BMI more than or equal to 40 kg per m²).
- •Pregnant and lactating women.
- •Patients who refuse to provide written informed consent.
结局指标
主要结局
Change in estimated glomerular filtration rate between the groups.
时间窗: 12 months.
次要结局
- Changes in muscle mass and muscle strength(1 year)
- Changes in blood pressure, volume overload and hyperkalemia(1 year)
- Nutritional status(1 year)
研究者
Shravana N C
Kasturba Medical College, Manipal, Manipal Academy of Higher Education, Manipal