Comparison · NCT01467466-f1c480e5
Sodium Bicarbonate vs Saline: Number of Participants With Serious, Adverse, Patient-Centered Events, Including Death, Need for Acute Dialysis, or Persistent Decline in Kidney Function, Comparing Intravenous Sodium Bicarbonate With Intravenous Sodium Chloride.
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
Cite this record
ConductScience Library. Sodium Bicarbonate vs Saline: Number of Participants With Serious, Adverse, Patient-Centered Events, Including Death, Need for Acute Dialysis, or Persistent Decline in Kidney Function, Comparing Intravenous Sodium Bicarbonate With Intravenous Sodium Chloride. Trial comparisons, record NCT01467466-f1c480e5. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT01467466-f1c480e5
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Measures6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note |
|---|---|---|---|---|---|
| Risk in group 1 | 0.0464 | 0.0387 | 0.0556 | wilson | |
| Risk in group 2 | 0.0488 | 0.0408 | 0.0582 | wilson | |
| Risk difference, group 1 minus group 2 | -0.00237 | -0.0145 | 0.00977 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.951 | 0.738 | 1.23 | log | |
| Odds ratio, group 1 over group 2 | 0.949 | 0.727 | 1.24 | log | |
| Number needed to treat, for one fewer participant with the outcome on Sodium Bicarbonate than on Saline | 421 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Sodium Bicarbonate | A grouping of participants receiving Sodium Bicarbonate. | 111 | 2,393 | OG000 |
| Group 2 | Saline | A grouping of participants receiving Saline. | 116 | 2,379 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- PRIMARY
- Title
Number of Participants With Serious, Adverse, Patient-Centered Events, Including Death, Need for Acute Dialysis, or Persistent Decline in Kidney Function, Comparing Intravenous Sodium Bicarbonate With Intravenous Sodium Chloride.
- Description
Death will be based on medical record and/or vital status registry documentation Need for acute dialysis will be defined as the initiation of any modality of renal replacement (intermittent hemodialysis, peritoneal dialysis, continuous renal replacement therapy, or sustained low-efficiency dialysis) Persistent decline in kidney function will be defined as an increase in serum creatinine of at least 50% from the baseline value collected pre-angiography to the measurement taken 90 days following the angiography.
- Time frame
- Within 90 days following angiography
- Population
Source ClinicalTrials.gov
Trial
- Title
- Prevention of Serious Adverse Events Following Angiography
- NCT number
- NCT01467466
- Phases
- PHASE3
- Conditions
- Acute Renal Failure, Kidney Disease, Coronary Artery Disease
- Interventions
- IV isotonic saline, IV isotonic bicarbonate, N-acetylcysteine, Placebo
- Lead sponsor
- VA Office of Research and Development
- Results first posted
- 2018-11-09
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT01467466?tab=results
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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