chronic kidney disease chronic renal disease
Conditions
Interventions
Sponsors
Eligibility
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
Exclusion criteria
Exclusion criteria: - plasma bicarbonate level >24 meq/L or 140/90 mmHg despite the use of 3 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 acid-base balance)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| the main study parameter is the change in urinary renin values (as urinary renin is assumed to most closely represent intrarenal RAS activity). | — |
Secondary
| Measure | Time frame |
|---|---|
| - Plasma bloodgas will be analysed, since this is part of the inclusion criteria and is likely to alter when bicarbonate is administered. - Plasma and urinary albumin will be measured, to enable correcting for glomerular filtration. - A correction using urinary creatinine is necessary because we have portions of urine, instead of 24-hour urine. - Plasma creatinine is needed to estimate the GFR, which will affirm the stage of CKD. - Plasma RAS components will be measured, to quantify and compare the activity of the systemic RAS. - Urinary angiotensinogen and aldosteron will be measured as they are important players in the RAS and in the past were imputed to represent the activity of the intrarenal RAS as well. - Electrolytes (sodium, potassium, chloride) will be measured in both urine and plasma. These urinary electrolytes, together with urea, NH4+ and measured osmolality will enable estimations of urinary bicarbonate levels. - Urinary kidney damage markers Endothelin-1, N-acetyl-*-D-glucosaminidase (NAG) and Transforming Growth Factor-* (TGF- *) will be used to check whether or not there is a significant change in processes leading to further damage to the kidney as a consequence of bicarbonate therapy. | — |
Countries
Netherlands