Ignite Creation Date:
2024-05-06 @ 8:02 PM
Last Modification Date:
2024-10-26 @ 3:19 PM
Study NCT ID:
NCT06237712
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-02-20
First Post:
2023-07-25
Brief Title:
Explorative Study to Investigate the Acid-base Response to Sodium and Potassium Salts in Patients With Chronic Kidney Disease
Sponsor:
Erasmus Medical Center
Organization:
Erasmus Medical Center
Study Overview
Official Title:
Explorative Study to Investigate the Acid-base Response to Sodium and Potassium Salts in Patients With Chronic Kidney Disease
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
5S
Brief Summary:
With this research the investigators want to study how patients with chronic kidney disease respond to different sodium- and potassium salts Potassium salts can prevent kidney damage and cardiovascular disease however patients with chronic kidney disease can responds differently Extra potassium can increase the amount of potassium in the blood and extra chloride can cause acidosis With this study the investigators will gain more insight in how patients with chronic kidney disease respond to sodium and potassium salts and which one is more favorableThis information can then be used to guide the application of salt substitutes and dietary adjustments in patients with chronic kidney disease
Detailed Description:
Rationale Patients with chronic kidney disease CKD consume a low potassium diet which is associated with progressive CKD and cardiovascular disease Increasing dietary potassium intake to recommended levels may therefore improve cardiorenal outcomes but the response to increased potassium intake in patients with CKD is unclear Therefore the investigators recently tested the response to 40 mmol potassium chloride in patients with CKD and showed that this is generally well-tolerated However patients did develop mild hyperchloremic metabolic acidosis which may offset the beneficial effects of potassium The investigators hypothesize that this is a form of chloride-induced acidosis that may be prevented by giving potassium with a different anion than chloride To further investigate this the investigators propose to test the response to five different sodium and potassium salts in patients with CKD These results should inform us on how to best correct a potassium-deficient diet in patients with CKD
Objective To test the effects of five different sodium and potassium salts in patients with CKD
Study design Investigator-initiated single-center placebo-controlled double-blind randomized crossover study
Study population Adult outpatients age 18 years with CKD stage G3b or G4 using renin-angiotensin-aldosterone system inhibitors RAAS-I
Intervention Capsules with 40 mmol potassium chloride potassium bicarbonate potassium gluconate sodium bicarbonate sodium chloride or placebo 3 x 3 capsules per day
Main study parametersendpoints Difference in plasma bicarbonate after treatment
Nature and extent of the burden and risks associated with participation benefit and group relatedness The study lasts 6 weeks and consists of 7 visits that will consist of blood sampling 24-hour urine collection and spot urine collection We will also provide an automated blood pressure measuring device for at home blood pressure measurements Although these procedures are time-consuming and may be experienced as burdensome they are all routine clinical measurements and safe Patients may experience a pill-burden The two risks of the salt supplements are hyperkalemia with potassium salts and hypertension with sodium salts Based on our previous studies a minority of patients is expected to develop these side-effects 12 Safety measures to prevent monitor and treat these side-effects are included in the study protocol There are no direct benefits for patients participating in this trial but the results will contribute to a better understanding on the feasibility of dietary modifications and salt substitution in patients with CKD to improve health Patients will be reimbursed for their participation
Objective To test the effects of five different sodium and potassium salts in patients with CKD
Study design Investigator-initiated single-center placebo-controlled double-blind randomized crossover study
Study population Adult outpatients age 18 years with CKD stage G3b or G4 using renin-angiotensin-aldosterone system inhibitors RAAS-I
Intervention Capsules with 40 mmol potassium chloride potassium bicarbonate potassium gluconate sodium bicarbonate sodium chloride or placebo 3 x 3 capsules per day
Main study parametersendpoints Difference in plasma bicarbonate after treatment
Nature and extent of the burden and risks associated with participation benefit and group relatedness The study lasts 6 weeks and consists of 7 visits that will consist of blood sampling 24-hour urine collection and spot urine collection We will also provide an automated blood pressure measuring device for at home blood pressure measurements Although these procedures are time-consuming and may be experienced as burdensome they are all routine clinical measurements and safe Patients may experience a pill-burden The two risks of the salt supplements are hyperkalemia with potassium salts and hypertension with sodium salts Based on our previous studies a minority of patients is expected to develop these side-effects 12 Safety measures to prevent monitor and treat these side-effects are included in the study protocol There are no direct benefits for patients participating in this trial but the results will contribute to a better understanding on the feasibility of dietary modifications and salt substitution in patients with CKD to improve health Patients will be reimbursed for their participation
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None