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Acidosis in CKD­ Treatment Now Study

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Current total funding for this study: $432,399

Author:

Matt Sparks
Nephrologist

Study Acronym:

ACT Now

Primary study question­ Does treating mild acidosis with either sodium bicarbonate or a diet rich in fruits and vegetables impact total mortality in patients with advanced CKD (eGFR of 15­-30)? 

Primary Outcome: 

Total Mortality 

Secondary study questions­ Does treating mild acidosis result in delay in initiation of RRT for ESRD or result in an improved quality of life? 

Secondary Outcome:
RRT for ESRD, Albuminuria Hospitalization, Quality of Life Score, Cost of Care Analysis 

Inclusion Criteria 

>Age 50
CKD with creatinine based eGFR <30 using CKD­Epi equation documented on 2 visits >6 months apart.
Serum bicarbonate <22 mmol/L 

Exclusion Criteria. 

  • acute kidney injury
  • planned to start RRT within next 3 months
  • decompensated heart failure
  • already on sodium bicarbonate therapy
  • terminally ill
  • active treatment for malignancy
  • acute diagnosis of primary glomerular disease with active biologic therapy or immunosuppressive therapy

Randomization.
Patients will be randomized into three arms:

  1. Sodium Bicarbonate Group: ­Patients will be provided with sodium bicarbonate tablets 500mg TID to be taken throughout study.
  2. Fruits and Vegetable Group­: Fruits such as apples, apricots, oranges, peaches, pears, raisins, and strawberries were predominantly provided. Vegetables such as carrots, cauliflower, eggplant, lettuce, potatoes, spinach, tomatoes, and zucchini will be provided to participants on a weekly basis. q6 month classes will be held to discuss recipes and tips for increasing consumption. q6 month food diary for all participants. Furthermore, dietary acid load will be calculated as described in this paper. 
  3. Placebo Group­: Placebo with rescue therapy with oral sodium bicarbonate at a level of 16 mmol/L

Comments (1)

This comment was minimized by the moderator on the site

Awesome, Matt. A friend from #Neurorad

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