Trial · NCT03509350
Vitamin C, Thiamine, and Steroids in Sepsis
NCT03509350, Phase 3, Completed, Emory University; results first posted 2020-09-18
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Vitamin C, Thiamine, and Steroids in Sepsis. Trials, record NCT03509350. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03509350
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Vitamin C, Thiamine, and Steroids in Sepsis
- NCT number
- NCT03509350
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 501 participants, actual
- Lead sponsor
- Emory University
- Conditions
- Sepsis
- Interventions
- Vitamin C, Thiamine, Hydrocortisone, Vitamin C Placebo, Thiamine Placebo, Hydrocortisone Placebo
- First posted
- 2018-04-26
- Last updated
- 2021-04-13
- Results first posted
- 2020-09-18
Source ClinicalTrials.gov
Registered outcomes19
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Vasopressor and Ventilator-free Days (VVFD) | Up to Day 30 | The primary outcome measure is VVFD in the first 30 days after the start of treatment. The endpoint was recorded to the nearest day. Participants who died are scored zero days, even if there was a period during which the participant was alive and free of vasopressors and mechanical ventilation. Participants who must return to ventilation and/or vasopressors had their counters reset at zero days. |
| Secondary | Mortality at 30 Days | Day 30 | The number of participants who did not survive until Day 30 is compared between study arms. |
| Secondary | Intensive Care Unit (ICU) Mortality | Day 30 | The number of participants who died while in the ICU is compared between study arms. |
| Secondary | Mortality at 180 Days | Day 180 | The number of participants who did not survive until Day 180 is compared between study arms. |
| Secondary | Length of ICU Stay | Day 30 | The number of days that participants were in the ICU is compared between study arms. |
| Secondary | Length of Hospital Stay | Day 30 | The number of days that participants were in the hospital is compared between study arms. |
| Secondary | Digit Span Test Score | Day 180 | The Digit Span Test is used to assesses attention. In the Digit Span Test, participants are read a series of numbers and are asked to repeat them back in the same order. The Digit Span test is scored by the number of digits the participant is able to remember in each test. Higher scores indicate greater ability to pay attention and to remember sequences. The average adult can remember about 7 numbers, plus or minus two, without making an error. |
| Secondary | Number of Participants With Delirium Assessed With the DeliriumTelephone Confusion Assessment Method (CAM) | Day 180 | The Telephone CAM evaluates dementia with 9-items, where additional questions are asked if symptoms are present. Rather than providing a summary score, if participants exhibit signs of a change in mental status which fluctuates and they experience inattention, along with disorganized thinking or altered level of consciousness, delirium is suggested. |
| Secondary | Hayling Test Score | Day 180 | Executive function is assessed with the Hayling Test. The Hayling Test includes two parts of 15 items each where participants complete sentences by providing the missing word. The test is scored as the amount of time it takes, in seconds, to recite a correct response and the appropriateness of the response (in Part 2). Scaled scores range from 1 to 10 where 1 = impaired, 6 = average, and 10 = very superior. |
| Secondary | Controlled Oral Word Association Test (COWAT) Score | Day 180 | Language is assessed with the Controlled Oral Word Association Test (COWAT). Participants generate words beginning with selected letters within 60 seconds. Generating a higher number of words indicates greater language skills. |
1 to 10 of 19Source ClinicalTrials.gov
See all 19 registered outcomesOutcomes19
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Vasopressor and Ventilator-free Days (VVFD) | Up to Day 30 | This analysis uses an intent-to-treat (ITT) analysis set, which includes all participants who enrolled in the study. | days | MEDIAN |
| SECONDARY | Mortality at 30 Days | Day 30 | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Intensive Care Unit (ICU) Mortality | Day 30 | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Mortality at 180 Days | Day 180 | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Length of ICU Stay | Day 30 | days | MEAN | |
| SECONDARY | Length of Hospital Stay | Day 30 | days | MEAN | |
| SECONDARY | Digit Span Test Score | Day 180 | numbers recalled | MEAN | |
| SECONDARY | Number of Participants With Delirium Assessed With the DeliriumTelephone Confusion Assessment Method (CAM) | Day 180 | Telephone data are available only on 168 participants | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Hayling Test Score | Day 180 | units on a scale | MEAN | |
| SECONDARY | Controlled Oral Word Association Test (COWAT) Score | Day 180 | words | MEAN |
1 to 10 of 19Source ClinicalTrials.gov
See all 19 outcomesResults by group38
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Vasopressor and Ventilator-free Days (VVFD) | Treatment Protocol | 25 | Inter-Quartile Range 0 to 29 | days | |
| Vasopressor and Ventilator-free Days (VVFD) | Control Protocol | 26 | Inter-Quartile Range 0 to 28 | days | |
| Mortality at 30 Days | Treatment Protocol | 56 | Participants | ||
| Mortality at 30 Days | Control Protocol | 60 | Participants | ||
| Intensive Care Unit (ICU) Mortality | Treatment Protocol | 52 | Participants | ||
| Intensive Care Unit (ICU) Mortality | Control Protocol | 49 | Participants | ||
| Mortality at 180 Days | Treatment Protocol | 102 | Participants | ||
| Mortality at 180 Days | Control Protocol | 94 | Participants | ||
| Length of ICU Stay | Treatment Protocol | 6.7 | Standard Deviation 7.3 | days | |
| Length of ICU Stay | Control Protocol | 6.4 | Standard Deviation 6.9 | days |
1 to 10 of 38Source ClinicalTrials.gov
See all 38 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Treatment Protocol | 252 | |
| Overall Study | STARTED | Control Protocol | 249 | |
| Overall Study | COMPLETED | Treatment Protocol | 252 | |
| Overall Study | COMPLETED | Control Protocol | 247 | |
| Overall Study | NOT COMPLETED | Treatment Protocol | 0 | |
| Overall Study | NOT COMPLETED | Control Protocol | 2 |
Source ClinicalTrials.gov
Adverse events4
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Hemorrhagic shock due to hemolysis | Blood and lymphatic system disorders | Treatment Protocol | 1 | 252 | 1 |
| other | Hemorrhagic shock due to hemolysis | Blood and lymphatic system disorders | Control Protocol | 0 | 249 | 0 |
| other | Worsening of renal function | Renal and urinary disorders | Treatment Protocol | 1 | 252 | 1 |
| other | Worsening of renal function | Renal and urinary disorders | Control Protocol | 0 | 249 | 0 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Treatment Protocol | 102 | 252 |
| Total, all-cause mortality | Control Protocol | 94 | 249 |
| Total, other adverse events | Treatment Protocol | 2 | 252 |
| Total, other adverse events | Control Protocol | 0 | 249 |
| Total, serious adverse events | Treatment Protocol | 0 | 252 |
| Total, serious adverse events | Control Protocol | 0 | 249 |
Source ClinicalTrials.gov
Papers6
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons7
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Treatment Protocol vs Control Protocol: Number of Participants With Delirium Assessed With the DeliriumTelephone Confusion Assessment Method (CAM) | Trial comparisons |
| Treatment Protocol vs Control Protocol: Intensive Care Unit (ICU) Mortality | Trial comparisons |
| Treatment Protocol vs Control Protocol: Mortality at 30 Days | Trial comparisons |
| Treatment Protocol vs Control Protocol: deaths from any cause | Trial comparisons |
| Treatment Protocol vs Control Protocol: Number of Participants Employed | Trial comparisons |
| Treatment Protocol vs Control Protocol: Mortality at 180 Days | Trial comparisons |
| Treatment Protocol vs Control Protocol: serious adverse events | Trial comparisons |
Tests4
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
| Test | Named as | Source |
|---|---|---|
| Digit Span Test | Secondary outcome | ConductCognition |
| Sentence Completion Inhibition Test | Secondary outcome | ConductCognition |
| Short Story Recall | Secondary outcome | ConductCognition |
| Verbal Fluency | Secondary outcome | ConductCognition |
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
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
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03509350
GET https://conductscience.org/api/trials/v1/NCT03509350/results?page=2