Sodium Bicarbonate Supplementation in Chronic Kidney Disease Evaluation of Dose Response, Safety and Beneficial Effects

Study Overview
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Brief Summary
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This study will enroll 25 patients with kidney disease to evaluate the effects of different doses of sodium bicarbonate (baking soda) on levels of bicarbonate in the blood, kidney function and muscle strength. The investigators will also evaluate safety and tolerability of different doses.

Detailed Description
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This study enrolled 20 patient to evaluate the effects of different doses of sodium bicarbonate. We will test serum bicarbonate levels, potassium levels and muscle function.

Official Title
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Sodium Bicarbonate Supplementation in Chronic Kidney Disease Evaluation of Dose Response, Safety and Beneficial Effects

Conditions
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Chronic Kidney Disease

Intervention / Treatment
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* Drug: Sodium bicarbonate
* Drug: Placebos


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Estimated GFR < 45 ml/min/1.73m2 and >15 ml/min/1.73 m2 determined by abbreviated 4 variable modification MDRD equation Age >21 Exclusion Criteria: Previous chronic treatment with alkali (including sodium bicarbonate, calcium carbonate or baking soda) Bicarbonate level <20 or >25 mEq/L Decompensated heart failure Systolic blood pressure >160 mm/Hg Moderate or greater lower extremity edema Initiation of ESRD treatment planned within 6 months Kidney transplantation Treatment with immunosuppressives within the last 3 months

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Sodium Bicarbonate<br>Sequential design. Participants will be getting different doses of sodium bicarbonate during the study. | Drug: Sodium bicarbonate<br>* Sodium bicarbonate at 3 different doses or placebo. The different doses tested will be: 0.3 mEq/kg of ideal body weight, 0.6 mEq/kg of ideal body weight and 1 mEq/kg pf ideal body weight<br>* Other names: sodium hydrogen carbonate;|
| Placebo Comparator: Placebos<br>Sequential design. Participants will be getting either placebo of different doses during the study. | Drug: Placebos<br>* Placebo at 3 different doses to match Sodium bicarbonate dosing<br>* Other names: identical-appearing placebo;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum Bicarbonate Levels |  | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Muscle Strength as Measured by sit-to Stand Test | 10 repetition sit-to-stand test | 8 weeks | 
| Systolic Blood Pressure |  | 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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metabolic acidosis, chronic kidney disease, Estimated GFR 15-45