Explorative Study to Investigate the Acid-base Response to Sodium and Potassium Salts in Patients With Chronic Kidney Disease.
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 31
- 试验地点
- 2
- 主要终点
- Plasma bicarbonate by blood draw
研究概览
简要总结
With this research the investigators want to study how patients with chronic kidney disease respond to different sodium- and potassium salts. Potassium salts can prevent kidney damage and cardiovascular disease, however patients with chronic kidney disease can responds differently. Extra potassium can increase the amount of potassium in the blood and extra chloride can cause acidosis. With this study the investigators will gain more insight in how patients with chronic kidney disease respond to sodium and potassium salts and which one is more favorable.This information can then be used to guide the application of salt substitutes and dietary adjustments in patients with chronic kidney disease.
详细描述
Rationale: Patients with chronic kidney disease (CKD) consume a low potassium diet which is associated with progressive CKD and cardiovascular disease. Increasing dietary potassium intake to recommended levels may therefore improve cardiorenal outcomes, but the response to increased potassium intake in patients with CKD is unclear. Therefore, the investigators recently tested the response to 40 mmol potassium chloride in patients with CKD and showed that this is generally well-tolerated. However, patients did develop mild hyperchloremic metabolic acidosis, which may offset the beneficial effects of potassium. The investigators hypothesize that this is a form of chloride-induced acidosis that may be prevented by giving potassium with a different anion than chloride. To further investigate this, the investigators propose to test the response to five different sodium and potassium salts in patients with CKD. These results should inform us on how to best correct a potassium-deficient diet in patients with CKD.
Objective: To test the effects of five different sodium and potassium salts in patients with CKD.
Study design: Investigator-initiated, single-center, placebo-controlled double-blind randomized crossover study.
Study population: Adult outpatients (age ≥ 18 years) with CKD stage G3b or G4 using renin-angiotensin-aldosterone system inhibitors (RAAS-I).
Intervention: Capsules with 40 mmol potassium chloride, potassium bicarbonate, potassium gluconate, sodium bicarbonate, sodium chloride or placebo (3 x 3 capsules per day).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients (≥ 18 years)
- •CKD G3b or G4 (44 - 15 ml/min/1.73 m2)
- •Use of RAAS-I (ACE-inhibitor or angiotensin receptor blocker, ARB)
排除标准
- •Use of any of the following drugs or supplements: mineralocorticoid receptor antagonists, potassium-sparing diuretics, oral potassium binders, immunosuppressive medication, tolvaptan, acetazolamide, topiramate, sodium bicarbonate.
- •Patients using double RAAS blockade (i.e., ACE-inhibitor + ARB).
- •Metabolic alkalosis (plasma bicarbonate >27 mmol/L) at last outpatient visit
- •Kidney transplant recipients
- •Patients with an active gastro-intestinal ulcer
- •Patients with previous history of ventricular cardiac arrhythmia
- •Patients with a life expectancy < 6 months
- •Incapacitated subjects or subjects who are deemed unfit to adequately adhere to instructions from the research team
- •Women who are pregnant, breastfeeding or consider pregnancy in the coming 7 weeks
- •Patients with chronic respiratory acidosis in previous medical history
- •Hyperkalemia (plasma potassium >5.5 mmol/L) at V0
研究组 & 干预措施
Sodium chloride
40 mmol of oral sodium chloride daily for 5 days
干预措施: Dietary supplement consisting of 40 mmol/daily of sodium chloride (Dietary Supplement)
Sodium bicarbonate
40 mmol of oral sodium bicarbonate daily for 5 days
干预措施: Dietary supplement consisting of 40 mmol/daily of sodium bicarbonate (Dietary Supplement)
Potassium chloride
40 mmol of oral potassium chloride daily for 5 days
干预措施: Dietary supplement consisting of 40 mmol/daily of potassium chloride (Dietary Supplement)
Potassium bicarbonate
40 mmol of oral potassium bicarbonate daily for 5 days
干预措施: Dietary supplement consisting of 40 mmol/daily of potassium bicarbonate (Dietary Supplement)
Potassium gluconate
40 mmol of oral potassium gluconate daily for 5 days
干预措施: Dietary supplement consisting of 40 mmol/daily of potassium gluconate (Dietary Supplement)
Placebo
干预措施: Placebo caps (Dietary Supplement)
结局指标
主要结局
Plasma bicarbonate by blood draw
时间窗: After 5 days of intervention
The absolute difference per treatment group in measured plasma bicarbonate after treatment. After each treatment of 5 days, plasma bicarbonate will be measured by blood sampling. The difference between the groups (treatments) will be the main outcome and comparator.
次要结局
- Plasma electrolyte levels(After 5 days of intervention)
- Urinary citrate(After 5 days of intervention)
- Titratable acid(After 5 days of intervention)
- Net acid excretion(After 5 days of intervention)
- Blood pressure(2 measurements in the morning and evening for 5 days per treatment repeated for 6 treatments in total)
- Urinary ammonia(After 5 days of intervention)
- Potential renal acid load(After 5 days of intervention)
- Body weight(After 5 days of intervention)
研究者
Ewout Hoorn
Prof. dr. Ewout Hoorn
Erasmus Medical Center