Comparison · NCT03389555-7c583f6f
Vitamin C, Vitamin B1, Corticosteroids vs Placebo: Number of Participants With Delirium
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. Vitamin C, Vitamin B1, Corticosteroids vs Placebo: Number of Participants With Delirium. Trial comparisons, record NCT03389555-7c583f6f. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT03389555-7c583f6f
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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 | 0.373 | 0.277 | 0.481 | wilson | |
| Risk in group 2 | 0.461 | 0.353 | 0.572 | wilson | |
| Risk difference, group 1 minus group 2 | -0.087 | -0.234 | 0.065 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.811 | 0.56 | 1.17 | log | |
| Odds ratio, group 1 over group 2 | 0.698 | 0.371 | 1.32 | log | |
| Number needed to treat, for one fewer participant with the outcome on Vitamin C, Vitamin B1, Corticosteroids than on Placebo | 11.5 | from the risk difference interval | the interval includes no difference |
Source ClinicalTrials.gov
Groups2
Group 2 names the comparator: placebo.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | Vitamin C, Vitamin B1, Corticosteroids | The combination of vitamin C, vitamin B1, hydrocortisone :~* Vitamin C (ascorbic acid) 1.5g every 6 hours x 4-days~* Vitamin B1 (thiamine) 100mg every 6 hours x 4-days~* Hydrocortisone 50mg every 6 hours x 4-days~vitamin C, vitamin B1, hydrocortisone: Vitamin C (1.5g) plus vitamin B1 (100mg) will be diluted in 100ml 0.9%NACL and administered IV every 6 hours for 4 days or until participant is discharged from the ICU. Hydrocortisone 50mg/ml will be administered via IV push over 1-2 minutes every 6hours for 4 days or until the patient is discharged from the ICU. | 31 | 83 | OG000 |
| Group 2 | Placebo | Normal Saline Solution (0.9%NaCl) in a volume to match all experimental arm components~Normal saline: Normal saline (0.9% NaCl solution) volume to match all components | 35 | 76 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- OTHER_PRE_SPECIFIED
- Title
- Number of Participants With Delirium
- Description
Describes if patient has delirium as defined by the Confusion Assessment Method (CAM)-ICU. The CAM-ICU method requires that the patient have 3 features to qualify for delirium:~1. Acute Onset of Changes or Fluctuations in the Course of Mental Status (AND )~2. Inattention (AND)~3. Disorganized thinking (OR) Altered Level of Consciousness
- Time frame
- On day 3 (at approximately 72 hours) after the first study drug dose
- Population
- We were able to assess CAM-ICU delirium on day 3 in only 83 patients from treatment and 76 patients from the control arm (unable to assess for remaining patients due to death or discharge)
Source ClinicalTrials.gov
Trial
- Title
- Ascorbic Acid, Corticosteroids, and Thiamine in Sepsis (ACTS) Trial
- NCT number
- NCT03389555
- Phases
- PHASE2, PHASE3
- Conditions
- Sepsis, Septic Shock, Metabolic Disturbance
- Interventions
- vitamin C, vitamin B1, hydrocortisone, Normal saline
- Lead sponsor
- Beth Israel Deaconess Medical Center
- Results first posted
- 2021-01-29
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT03389555?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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