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The effect of correction of metabolic acidosis in chronic kidney disease on intrarenal RAS activity.

The effect of correction of metabolic acidosis in chronic kidney disease on intrarenal RAS activity. - BIC study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON45074
Enrollment
48
Registered
2013-07-30
Start date
2014-04-25
Completion date
Unknown
Last updated
2024-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

chronic kidney disease chronic renal disease

Interventions

sodium bicarbonate 1000mg thrice daily, for 2 weeks sodiumchloride 1000mg twice daily, for 2 weeks

Sponsors

Erasmus MC, Universitair Medisch Centrum Rotterdam
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

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

MeasureTime 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

MeasureTime 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

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)