Alkali therapy of metabolic acidosis in patients with chronic kidney disease Urological and Genital Diseases
Conditions
Interventions
Based on their level of serum bicarbonate, subjects will receive either high doses or low doses of sodium bicarbonate or sodium citrate.
Computer-generated randomization will be perfor
Sponsors
Institutul Clinic Fundeni
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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)
Exclusion criteria
Exclusion criteria: 1. Hipokalemia 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 1. All-cause mortality measured using patient records at the end of the study 2. ESRD measured using a blood sample for CKD-EPI Equation for Glomerular Filtration Rate (GFR) at baseline (Bs) and monthly to the end of the study (EOS). 3. Urinary albumin/creatinine ratio (RAC) measured from a spot urine sample at baseline (Bs) and monthly to the end of the study (EOS). 4. Serum albumin measured using blood sample at baseline (Bs) and monthly to the end of the study (EOS). 5. Serum soluble plasminogen activator urokinase receptor (suPAR) measured from a venous blood sample at baseline (Bs) and monthly to the end of the study (EOS). 6. Arterial stiffness measured by sphygmoCor technology (pulse wave analysis) at baseline (Bs) and monthly to the end of the study (EOS). Safety endpoints Percentage of patients who develop during the study: 1. Blood pressure >140/90 mmHg measured using a manual sphygmomanometer 2. Hypervolemia - peripheral edema or dyspnea with crackles (appreciated clinically and on auscultation with a stethoscope) or high blood pressure needing initiation or escalation of antihypertensive medication or diuretics measured using a manual sphygmomanometer 3. Hypokalemia 28 mEq/L measured using a blood sample 5. Calciphylaxis diagnosed by clinical presentation 6. Digestive symptoms (nausea, vomiting) by self report | — |
Countries
Romania
Outcome results
None listed