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Comparison · NCT04600323-sae

Sodium Bicarbonate vs Placebo: serious adverse events

Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.

2 sourcestrial-comparisons-2026-03-23-0.1.0

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ConductScience Library. Sodium Bicarbonate vs Placebo: serious adverse events. Trial comparisons, record NCT04600323-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT04600323-sae

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Measures6

Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.

MeasureValue95% interval, lower95% interval, upperMethodNote
Risk in group 10.3330.1630.563wilson
Risk in group 20.4380.2310.668wilson
Risk difference, group 1 minus group 2-0.104-0.3910.204newcombe hybrid score
Risk ratio, group 1 over group 20.7620.3231.8log
Odds ratio, group 1 over group 20.6430.162.58log
Number needed to treat, for one fewer participant with a serious adverse event on Sodium Bicarbonate than on Placebo9.6from the risk difference intervalthe interval includes no difference

Groups2

Group 2 names the comparator: placebo.

GroupTitleDescriptionWith the outcomeAnalysedClinicalTrials.gov code
Group 1Sodium BicarbonateSodium bicarbonate will be used at a dose of 0.5 mEq/kg-lean body weight/day.~Sodium Bicarbonate Tablets: Participants will be given sodium bicarbonate at 0.5 mEq/kg-LBW/day for 12 months618EG001
Group 2PlaceboPlacebo medication will be used at a dose of 0.5 mEq/kg-lean body weight/day~Placebo: Participants will be given placebo at 0.5 mEq/kg-LBW/day for 12 months716EG000

Harm

What it counts
Total, serious adverse events
Time frame
12 months

Source ClinicalTrials.gov

Trial

Title
Bicarbonate Administration and Cognitive Function in Midlife and Older Adults With CKD
NCT number
NCT04600323
Phases
EARLY_PHASE1
Conditions
Metabolic Acidosis, Chronic Kidney Disease, Cognitive Dysfunction
Interventions
Sodium Bicarbonate Tablets, Placebo
Lead sponsor
University of Colorado, Denver
Results first posted
2024-12-20

Source ClinicalTrials.gov

Source

Release
trial-comparisons-2026-03-23-0.1.0
Release manifest SHA-256
f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
AACT copy
2026-03-23
Tables read
outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet

Source ClinicalTrials.gov

Sources 2

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.

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