Test the effect of five different sodium- and potassium salts in patients with chronic kidney disease.
ID
Source
Brief title
Condition
- Acid-base disorders
- Nephropathies
- Vascular hypertensive disorders
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Changes in plasma bicarbonate.
Secondary outcome
Effects on plasma potassium and chloride, acid-base parameters in urine and
plasma, blood pressure and body weight.
Background summary
The beneficial effect of potassium salt on kidney function, blood pressure and
cardiovascular disease is becoming clearer, even for patients with chronic
kidney disease. In a recent study we showed that suppletion with potassium
chloride (to correct the dietary deficit) is well tolerated, but caused a mild
hyperchloremic metabolic acidosis. Metabolic acidosis has detrimental effects
and could therefore offset the potential effects of potassium. We think that
chloride is responsible for this metabolic acidosis.
Study objective
Test the effect of five different sodium- and potassium salts in patients with
chronic kidney disease.
Study design
Double-blind, placebo controlled randomized cross-over study with wash-out.
Intervention
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 will be given via 3 x 3
capsules per day that in total contain 40 mmol potassium or sodium).
Study burden and risks
- 7 study visits in 6 weeks.
- At home daily blood pressure measurements, 3 times daily.
- Every study visit: 24-h urine collecetion (the day before), blood sample (4
tubes), urine portion and body weight measurement.
- Daily intake of 9 capsules (3 times per day 3 capsules)
Dr Molewaterplein 40
Rotterdam 3015 GD
NL
Dr Molewaterplein 40
Rotterdam 3015 GD
NL
Listed location countries
Age
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
- 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 < 6 months
- Incapacitated subjects or subjects who are deemed unfit to adequately adhere
to instructions from the research team
- Women who are pregnant, breastfeeding or consider pregnancy in the coming 7
weeks
- Patients with chronic respiratory acidosis in previous medical history
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| CCMO | NL84462.078.23 |