Metabolic acidosis in chronic kidney disease
Conditions
Interventions
Product Name: Sodium bicarbonate
Pharmaceutical Form: Tablet
Product Name: Sodium chloride
Pharmaceutical Form: Tablet
Sponsors
None listed
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - male or female adult (>18 years) - chronic kidney disease stage 4, i.e. eGFR (MDRD) 15-30 ml/min - plasma bicarbonate concentration of 15 meq/L, the latter because in that case it seems highly recommended to start sodiumbicarbonate suppletion and not to postpone this Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 22 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 23
Exclusion criteria
Exclusion criteria: - plasma bicarbonate level >24 meq/L or 140/90 mmHg despite the use of 3 or more different antihypertensives - a history of inadherence to medication - use of calcineurin inhibitors (these immunosuppressive drugs are known to induce metabolic acidosis and influence electrolytes and acidbase balance)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To study if sodiumbicarbonate therapy diminishes activity of the intrarenal renin-angiotensin-system (RAS) without affecting the systemic RAS, i.e. the intrarenal RAS can be inhibited by oral alkali in CKD patients with metabolic acidosis.;Secondary Objective: - To study if sodium bicarbonate therapy in patients with metabolic acidosis due to chronic kidney disease effects kidney damage markers. - To study whether or not there is a difference in alteration of levels of RAS components in response to sodium bicarbonate therapy in patients with metabolic acidosis due to chronic kidney disease treated with AT-1 receptor blockade and without.;Primary end point(s): Study ends after 4 weeks (in which the patient recieved Sodium Bicarbonate, Sodium Chloride or none of both). Main study parameter is urinary renin levels.;Timepoint(s) of evaluation of this end point: not applicable | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): not applicable;Timepoint(s) of evaluation of this end point: not applicable | — |
Countries
Netherlands
Outcome results
None listed