Comparison · NCT03422159-sae
Treatment Arm vs Placebo Arm: serious adverse events
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
Download JSON
Cite this record
ConductScience Library. Treatment Arm vs Placebo Arm: serious adverse events. Trial comparisons, record NCT03422159-sae. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03422159-sae
On this page
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 | 0 | 0.0535 | wilson | |
| Risk in group 2 | 0 | 0.00000000000000000347 | 0.0527 | wilson | |
| Risk difference, group 1 minus group 2 | 0 | -0.0527 | 0.0535 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | log | a group has no participants with the outcome | |||
| Odds ratio, group 1 over group 2 | log | a cell of the two-by-two table is zero | |||
| Number needed to harm | from the risk difference interval | the two groups' risks are equal |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: placebo.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Treatment Arm | Based on published clinical data, vitamin C pharmacokinetic modeling, the package insert as well as the preliminary study by Marik et al, Vitamin C will be administered as an intravenous dose of 6gm per day divided in 4 equal doses. This dosage is reported to be devoid of any complications or side effects. Hydrocortisone will be dosed according to the consensus guidelines of the American College of Critical Care Medicine. Thiamine will be administered according to current recommendations in a dose of 200mg q 12 hourly. This will be continued for 4 days, or less if discharged from the ICU prior.~Ascorbic Acid: Ascorbic Acid 1.5g IV piggyback every 6 hours for 4 days (or discharge from ICU if prior to 4 days).~Thiamine: Thiamine 200mg IV piggyback every 12 hours for 4 days (or discharge from ICU if prior to 4 days).~Hydrocortisone: Hydrocortisone 50mg IV push every 6 hours for 4 days (or discharge from ICU if prior to 4 days). | 0 | 68 | EG000 |
| Group 2 | Placebo Arm | Vitamin C placebo will consist of an identical bag of 100mL normal saline (but with no vitamin C) and will be labeled Vitamin C or Placebo. Placebo will be infused over 30 minutes as per the infusion instructions of the active vitamin and protected from light with a brown bag. Hydrocortisone placebo will be provided as an identical 3mL syringe as 1mL of normal saline.The thiamine placebo will be placed in a 50mL bag of Normal Saline labeled Thiamine 200mg or Placebo and run over 30 minutes (100mL/hr) Placebo patients will receive a matching 50mL bag of Normal Saline. All of these will be given for up to 4 days, or less if discharged from the ICU prior.~Sodium Chloride 0.9%: Placebo Ascorbic Acid 100mL IV piggyback every 6 hours, Placebo Thiamine 50mL IV piggyback every 12 hours, and Placebo Hydrocortisone IV push every 6 hours for 4 days (or discharge from ICU if prior to 4 days). | 0 | 69 | EG001 |
Source ClinicalTrials.gov
Harm
- What it counts
- Total, serious adverse events
- Time frame
Source ClinicalTrials.gov
Trial
- Title
- Metabolic Resuscitation Using Ascorbic Acid, Thiamine, and Glucocorticoids in Sepsis.
- NCT number
- NCT03422159
- Phases
- PHASE2
- Conditions
- Sepsis, Severe, Septic Shock
- Interventions
- Ascorbic Acid, Thiamine, Hydrocortisone, Sodium Chloride 0.9%
- Lead sponsor
- Community Medical Center, Toms River, NJ
- Results first posted
- 2021-09-21
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03422159?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.
For software
Read this comparison from software.
The record is JSON. No key.
GET https://conductscience.org/api/comparisons/v1/NCT03422159-sae