A Prospective, Controlled, Randomized, Multicentric Study: Correction of Metabolic Acidosis With Use of Bicarbonate in Chronic Renal Insufficiency (CKD3b-4)
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 728
- 试验地点
- 2
- 主要终点
- doubling of creatinine
研究概览
简要总结
The investigators want to evaluate whether an original action based on the administration of alkali (mainly sodium bicarbonate) is able to significantly modify renal death and to reduce mortality due to cardiovascular events.
Methods: This is a proposal of Multicentric, prospective, cohort, randomized, open-label and controlled study.
The investigators will Randomize 728 patients with Chronic Kidney Disease(CKD) stage 3b (CKD-3b) and CKD stage 4: 364 of these patients will be included in the study group called Bicarbonate Group (Bic), in which levels of bicarbonate should be kept > 24 mEq/l; the other 364 patients will included in the Usual Treatment Group (no-Bic).
Results: The aim of the Research Protocol is to demonstrate if that the optimal correction of uremic acidosis (with administration of sodium bicarbonate or of any other alkalinizing agent, e.g. sodium citrate) reduces renal and cardiovascular mortality.
Conclusions. In conclusion the Work Group of the Conservative Therapy for Chronic Renal Insufficiency proposes this cohort, randomized, controlled, prospective, multicentric study to evaluate the effects of correction of acidosis on the progression of the kidney disease considered as renal death in End-Stage Renal Disease (ESRD) patients.
详细描述
Rationale:
Chronic Kidney Disease (CKD) is associated with a high incidence of morbility and mortality.
In this regard, the National Health and Nutrition Examination Survey (NANHES) shows that 19% of the uremic population presents metabolic acidosis (CKD stage 4). This high prevalence and the low costs of the correction by bicarbonate pave the way for a potential and interesting research activity.
In fact, a Cochrane Collaboration review reports that there is no evidence for correction of acidosis by sodium bicarbonate in pre-End-Stage Renal Disease) (ESRD) patients, and concludes that randomized controlled trials (RCTs) are necessary to evaluate the benefits and harms of correcting metabolic acidosis in pre-ESRD patients.
During the same year, 2009, another RCT appears in the scientific literature showing that the administration of sodium bicarbonate, and the consequent correction of acidosis, slows the progression of CKD and improves the nutritional status in ESRD patients stages 4-5. This study was randomized, prospective, open-label, monocentric, and was conducted on 134 patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- •End stage renal disease
排除标准
- •Neoplastic diseases
- •Autoimmune diseases
- •Decompensation class III-IV
- •Uncontrollable hypertension
- •Amputation of the limbs
- •Previous ictus cerebri
- •Neobladder, ureterosigmoidostomy
- •Sever acidosis with bicarbonate < 18 mEq/l
- •Use of calcium carbonate (relative exclusion factor: patients who used to take this drug and suspended it before the beginning of the 3-month run-in period can be included in the study).
研究组 & 干预措施
Bicarbonate
干预措施: Bicarbonate (Dietary Supplement)
no intervention
结局指标
主要结局
doubling of creatinine
时间窗: 36 months
the primary outcome will be reached when the seric creatinine level (mg/dl) will double compared to the basal value.
次要结局
- start of renal replacement therapy(36 month)
- all-cause death(36 month)
研究者
Dr Biagio Di Iorio
Principal Investigator
Azienda Sanitaria ASL Avellino 2