AC/DC Study: Acidification Test in Patients With Chronic Kidney Disease and Healthy Controls
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 29
- 试验地点
- 2
- 主要终点
- Urinary renin
研究概览
简要总结
In this study the effect of an acute acid load on the intrarenal renin angiotensin-system is evaluated in patients with chronic kidney disease and healthy controls
详细描述
Metabolic acidosis is one of the metabolic complications of chronic kidney disease (CKD). Correction of metabolic acidosis in CKD has been shown to prevent further loss of kidney function over time. Currently, a clinical trial (the BIC-study, MEC-2013-332) is conducted in which patients with CKD and metabolic acidosis receive sodium bicarbonate, sodium chloride, or no treatment (time control) to address the hypothesis that the beneficial effects of acidosis correction are mediated through inhibition of the intrarenal renin-angiotensin system (RAS). It is unknown, however, if and how acute changes in acid-base status affect the intrarenal RAS during CKD. In the present study it is hypothesized that an acute acid load increases the activity of the intrarenal RAS, and that this response is exaggerated in patients with CKD compared with healthy controls.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- •CKD patients
- •Plasma bicarbonate level < 20.0 mmol/l
- •Serum potassium >5.5 mmol/l
- •Sodium bicarbonate use in the month preceding the test
- •Heart failure (NYHA III or IV)
- •Liver cirrhosis (Child Pugh B or C)
- •Blood pressure >140/90 mmHg despite the use of 3 different anti-hypertensive drugs
- •Kidney transplantation
- •Use of calcineurin inhibitors (these immunosuppressive drugs affect acid-base balance)
- •Known urea cycle disorder
- •Alcoholism or drug use
- •Pregnancy
- •Current use of antibiotics, NSAIDS or alkalizing drugs (sodium-bicarbonate, citric acid, potassium citrate, acetazolamide)
- •Inability to adhere to the study protocol (due to language barrier or intellectual disability)
- •Healthy controls:
- •eGFR < 90 ml/min/1.73 m2 (calculated using the CKD-EPI equation)
- •Plasma bicarbonate < 20 mmol/l
- •History of, or drugs for, diabetes mellitus
- •History of chronic diarrheal disease
- •Ileostomy/colostomy
- •Known urea cycle disorder
- •Alcoholism or drug use
- •Pregnancy
- •Current use of antibiotics, antihypertensive drugs, NSAIDS or alkalizing drugs (sodium-bicarbonate, citric acid, potassium citrate, acetazolamide)
- •Inability to adhere to the study protocol (due to language barrier or intellectual disability)
结局指标
主要结局
Urinary renin
时间窗: up to 6 hours
次要结局
未报告次要终点
研究者
Ewout Hoorn
doctor
Erasmus Medical Center