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Explorative study to investige the acid-base response to five sodium and potassium salts in patients with chronic kidney disease (5Z study)

Explorative study to investige the acid-base response to five sodium and potassium salts in patients with chronic kidney disease (5Z study) - 5Z study

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON56418
Enrollment
31
Registered
2023-11-13
Start date
2024-01-26
Completion date
Unknown
Last updated
2025-09-08

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

Conditions

Acid-base disorder acidification of the blood

Interventions

Randomized treatment with potassium chloride, potassium bicarbonate, potassium gluconate, sodium chloride, sodium bicarbonate and placebo (6 x 5 days treatment followed by 2 days wash-out, the salts

Sponsors

Erasmus MC, Universitair Medisch Centrum Rotterdam
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Adult patients (above 18 years) with CKD stage 3b or 4 (44 - 15 ml/min/1.73 m2) Use of RAAS-inhibitors

Exclusion criteria

Exclusion criteria: - Use of any of the following drugs or supplements: mineralocorticoid receptor blockers, potassium-sparing diuretics, oral potassium binders, immunosuppressive medication, tolvaptan, acetazolamide, topiramate, sodium bicarbonate. Patients using double RAAS blockade (i.e., ACE-inhibitor + ARB). - Kidney transplant recipients - Patients with an active gastro-intestinal ulcer - Patients with previous history of ventricular cardiac arrhythmia - Patients with a life expectancy

Design outcomes

Primary

MeasureTime frame
Changes in plasma bicarbonate.

Secondary

MeasureTime frame
Effects on plasma potassium and chloride, acid-base parameters in urine and plasma, blood pressure and body weight.

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)