Sodium citrate versus sodium bicarbonate for increased acidity (metabolic acidosis) in patients with chronic kidney disease
- Conditions
- Alkali therapy of metabolic acidosis in patients with chronic kidney diseaseUrological and Genital Diseases
- Registration Number
- ISRCTN16429332
- Lead Sponsor
- Institutul Clinic Fundeni
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Ongoing
- Sex
- All
- Target Recruitment
- 50
1. Age >18 years
2. eGFR 15-45 ml/min/1.73 m² CKD EPI
3. Serum bicarbonate 10-22 mmol/l on to two different ocassions
4. Ability to travel to study visits
5. Ability to follow the study treatment regimen
6. A wash-out period of one month if previous alkali therapy (such as sodium bicarbonate, sodium citrate, potassium citrate, baking soda, etc)
1. Hipokalemia <3 meq/l
2. Uncontrolled blood pressure (>150/90 mmhg under treatment with more than 3 different classes of antihypertensive drugs, including diuretics)
3. Heart failure with active class III or IV New York Heart Association, known left ventricular ejection fraction =30%, or hospital admission for heart failure within the past 3 months
4. Hypervolemia of any cause (nephrotic syndrome, liver, or heart failure) considered unsafe for the patient by the PI for the patient
5. Active hepatic disease
6. Chronic gastrointestinal disorder (treatment adherence unreliable)
7. Active malignancy
8. Pregnancy
9. Patients taking amilorid or sevelamer
10. Patients refusing to sign the informed consent
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Decline in renal function assessed by changes in eGFR (CKD-EPI equation) and change in serum bicarbonate assessed by a venous blood sample from baseline (Bs) and monthly to the end of the study (EOS) (12 months)
- Secondary Outcome Measures
Name Time Method