Efficacy of standard care Vs non-dialysis day bicarbonate supplementation on steady correction of metabolic acidosis in Indian CKD patients and clinical outcomes: a multicentric study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 398
- 试验地点
- 3
- 主要终点
- Comparing change in serum Bicarbonate level immediately before dialysis (IPD) and one day prior to dialysis (DPD) in the study groups.
研究概览
简要总结
**Summary:**Rationale: Hemodialysis corrects metabolic acidosis in saw tooth manner with risk of alkalosis and over correction on dialysis days and acidosis on non-dialysis days. In resource limited settings, bicarbonate levels are rarely tested due to poor follow-up, unavailability of nephrologists, geographic and cost constraints. Chronic metabolic acidosis with intermittent correction leads to hyperkalemia and worse outcomes of bone health, catabolic state and cardiovascular events. Western data on bicarbonate supplementation and dialysis cannot be applied due to different dietary patterns, affordability and availability of dialysis. Novelty: We propose a pragmatic, real world study in Indian dialysis patients to assess efficacy of steady correction of metabolic acidosis without altering dialysis regime, using a relatively inexpensive medication i.e. oral Bicarbonate on non dialysis days versus routine care consisting of acidosis correction only during dialysis. Objectives: Comparing change in serum Bicarbonate level immediately prior to dialysis (IPD) and one day prior to dialysis (DPD), bone turnover bio markers (b-ALP, s-PINP and TRAP-5B), nutritional status, muscle strength and function in study groups. Methods: Intervention arm patients will be given Oral bicarbonate as per protocol. Bicarbonate levels will be measured per 2 weeks. Clinical investigations will be recorded and blood samples will be collected at baseline and follow-up at all study sites. Nutritional status will be monitored using bioimpedence and ‘SGA format for CKD’. Bone turnover will be analyzed using ELISA. Muscle strength and functionality will be tested using various exercises and dynamometry. Expected Outcomes: will be applicable to all Indian patients on dialysis.If found effective, this will establish the usefulness of a relatively inexpensive measure to improve outcomes in CKD.
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 65.00 Year(s)（—）
- 性别
- All
入选标准
- •All CKD adult patients on hemodialysis aged 18 to 65 years
- •Stable on hemodialysis more than 12 weeks
- •Immediately pre-dialysis serum bicarb concentration 22 mEq per L.
排除标准
- •Moribund patient : Patients with any condition at the time of randomization who likely to within 3 months as deemed by treating physician.
- •Mentally ill :Any patient with diagnosed psychiatric condition or receiving psychiatric treatment of any kind will be excluded from the study.
- •No acute illnesses, any respiratory and cardiovascular disease and sever liver disease.
- •Patients with history of stroke
- •bed ridden patients.
结局指标
主要结局
Comparing change in serum Bicarbonate level immediately before dialysis (IPD) and one day prior to dialysis (DPD) in the study groups.
时间窗: 0 and 3 months
次要结局
- Comparing change in nutritional status (serum albumin level, pre albumin, cholesterol, bioimpedance and Subjective Global Assessment (SGA)) in study groups.
- Change in bone turnover bio markers b-ALP, s-PINP and TRAP-5B in two study groups(0 and 3 months)
- To assess change in muscle strength and function (Handgrip strength and short physical performance battery: Gait speed, sit to stand test and static balance test) among two study groups(0 and 3 months)
研究者
Smita Divyaveer
Post Graduate Institute of Medical Education and Research, Chandigarh, India