Effect of correction of metabolic acidosis on CKD progression – A randomised controlled trial
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 126
- 试验地点
- 1
- 主要终点
- 1.To assess the effect of metabolic acidosis correction on eGFR in patients with CKD stage 3 and 4
研究概览
简要总结
This study aims to compare the effects of correcting metabolic acidosis to achieve venous bicarbonate levels of 24 to 28 meq/L in patients with chronic kidney disease (CKD) versus standard care alone. Previous research from our center has not shown clear benefits, largely because many patients were unable to reach these bicarbonate levels, particularly those with severe metabolic acidosis. To address this, the current trial will include early-stage CKD patients. It is expected to generate data on two important outcomes related to metabolic acidosis : albuminuria and eGFR decline. The findings will provide evidence on the effect of alkali supplementation on CKD progression and offer insights into dietary acid load, potentially leading to personalized bicarbonate prescriptions based on net endogenous acid production (NEAP).
All patients attending the Nephrology OPD will be screened for recruitment in to the study based on the inclusion and exclusion criteria. For eligible patients who were already on bicarbonate supplementation, the same will be stopped one month prior to the randomization and venous bicarbonate levels will be assessed . All consenting participants will be randomized to SOC vs SOC + bicarbonate supplementation for 6 months. All patients will be given dietary counselling before randomisation. Generic tablets of sodium bicarbonate containing 500 mg of sodium bicarbonate (6 mEq) will be used. Patients would be instructed to take the tablets 1 h after food to reduce the gastrointestinal side effects. Co-prescription of calcium carbonate will be avoided as CaCO3 being a potential source of bicarbonate. The compliance to medication will be checked by a social worker by assessing pill counts on monthly follow-up visits as well as by telephone calls. Taking more than 80% of prescribed medications will be considered as compliance with therapy. Due to the concern of sodium load, the maximum permissible number of sodium bicarbonate tablets will be 16 (96 mEq of sodium bicarbonate).
The starting dose of sodium bicarbonate will be standardised depending on the venous bicarbonate level.
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 85.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Chronic kidney disease stage 3 and
- •2.Venous bicarbonate levels 18-22 mEq/L documented on 2 occasions 1 month apart 3.should not have received bicarbonate supplementation for a period of 4 weeks prior to recruitment 4.documented stable eGFR, less than 5 percentage change in the preceding 3 months.
排除标准
- •1.Symptomatic Hypocalcemia 2.Patients being considered for elective renal replacement in the subsequent six months 3.Patients with any significant comorbidities limiting life expectancy 4.Nephrotic range proteinuria 5.Decompensated heart failure with New York heart association (NYHA) class 3 or 4 symptoms 5.Decompensated chronic liver disease 6.Pregnancy 7.Persistent volume overload despite optimal diuretic therapy 8.Kidney transplant 9.Use of immunosuppression 10.A recent history of acute kidney injury (according to the KDIGO criteria) in the preceding three months, prior to recruitment 11.Respiratory disorders associated with hypercapnia 12.serum potassium less than 3 or more than 5.5 milliequivalent per litre.
- •13.serum bicarbonate less than 18 meq per litre 14.Uncontrolled hypertension as defined by BP more than SBP 160 and DBP 90 on maximal dosage of three antihypertensives and one diuretic.
结局指标
主要结局
1.To assess the effect of metabolic acidosis correction on eGFR in patients with CKD stage 3 and 4
时间窗: 0 and 6 months
2.To assess the effect of Metabolic acidosis correction on urine albumin creatinine ratio in patients with CKD stage 3 & 4
时间窗: 0 and 6 months
次要结局
- To assess the effect of MA correction on dietary acid load(Net endogenous acid production, potential renal acid load and urine net acid excretion )in patients with CKD stage 3 & 4
研究者
Dr Priyamvada PS
jawaharlal institute of postgraduate medical education and research