Trial · NCT03389555
Ascorbic Acid, Corticosteroids, and Thiamine in Sepsis (ACTS) Trial
NCT03389555, Phase 2, Phase 3, Completed, Beth Israel Deaconess Medical Center; results first posted 2021-01-29
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Ascorbic Acid, Corticosteroids, and Thiamine in Sepsis (ACTS) Trial. Trials, record NCT03389555. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03389555
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Ascorbic Acid, Corticosteroids, and Thiamine in Sepsis (ACTS) Trial
- NCT number
- NCT03389555
- Status
- Completed
- Phases
- Phase 2, Phase 3
- Enrollment
- 205 participants, actual
- Lead sponsor
- Beth Israel Deaconess Medical Center
- Conditions
- Sepsis, Septic Shock, Metabolic Disturbance
- Interventions
- vitamin C, vitamin B1, hydrocortisone, Normal saline
- First posted
- 2018-01-03
- Last updated
- 2021-02-16
- Results first posted
- 2021-01-29
- Limitations and caveats
Ongoing or planned corticosteroid use was the most common exclusion criterion, perhaps eliminating a subset of patients more likely to benefit from corticosteroids. Some patients were discharged alive from the ICU within 96 hours of enrollment; thus, many patients did not receive a full 4 days of study drug
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Sequential Organ Failure Assessment (SOFA) Score at Baseline and 72 Hours | Enrollment to 72-hours | Sequential Organ Failure Assessment (SOFA) Score at Baseline and 72 Hours. The SOFA score ranges from a minimum of 0 to a maximum of 24, with higher scores meaning worse outcomes. |
| Secondary | Renal Failure | Enrollment until 7-days or discharge from the ICU | Development of renal failure as defined by a Kidney Disease Improving Global Outcomes \[KDIGO\] stage 3 or higher. There are 3 stages in the KDIGO scale with stage 3 being the worst (corresponds to renal failure). Stage 1- serum creatinine 1.5 to 1.9 times baseline OR an increase in serum creatinine ≥ 0.3 mg/dL OR urine output \< 0.5ml/kg/hour for 6-12 hours. Stage 2- serum creatinine 2.0-2.9 times baseline OR urine output \<0.5mg/kg/hour for ≥ 12 hours Stage 3- serum creatinine 3.0 times baseline (or serum creatinine of more than or equal to 4.0 mg/dl with an acute increase of at least 0.5 mg/dl) (OR) Urine output less than 0.3 ml/kg/hour for 24 hours or anuria for 12 hours or new renal replacement therapy |
| Secondary | 30-day Mortality | Enrollment until 30-days after enrollment | Mortality rate |
| Other | Ventilator Free Days | Ventilator free days over the first 7-days after enrollment | Days not receiving invasive mechanical ventilation |
| Other | Shock Free Days | Vasopressor free days over the first 7-days after enrollment | Days not receiving vasopressor |
| Other | ICU Free Days | From enrollment until 28 days after enrollment | Number of days that the patient was not in the ICU. Timeframe listed below. |
| Other | Hospital Mortality | Enrollment until hospital discharge, death, or 30-days. Whichever comes first. | Hospital mortality rate |
| Other | Intensive Care Unit (ICU) Mortality | Enrollment until ICU discharge, death, or 30-days. Whichever comes first. | ICU mortality rate |
| Other | Number of Participants With Delirium | On day 3 (at approximately 72 hours) after the first study drug dose | 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 |
| Other | Hospital Disposition: Survivors Discharged Home | Enrollment until hospital discharge, death, or 30-days, whichever comes first. | Home hospital disposition in patients who survive to discharge |
Source ClinicalTrials.gov
Outcomes10
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Sequential Organ Failure Assessment (SOFA) Score at Baseline and 72 Hours | Enrollment to 72-hours | For the 72 hour SOFA score, patients who expired prior to that time point are excluded from the calculation of mean (SD) of the 72 hour SOFA score. | Units on a scale | MEAN |
| SECONDARY | Renal Failure | Enrollment until 7-days or discharge from the ICU | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | 30-day Mortality | Enrollment until 30-days after enrollment | Participants | COUNT_OF_PARTICIPANTS | |
| OTHER_PRE_SPECIFIED | Ventilator Free Days | Ventilator free days over the first 7-days after enrollment | Days | MEDIAN | |
| OTHER_PRE_SPECIFIED | Shock Free Days | Vasopressor free days over the first 7-days after enrollment | Days | MEDIAN | |
| OTHER_PRE_SPECIFIED | ICU Free Days | From enrollment until 28 days after enrollment | Days | MEDIAN | |
| OTHER_PRE_SPECIFIED | Hospital Mortality | Enrollment until hospital discharge, death, or 30-days. Whichever comes first. | Participants | COUNT_OF_PARTICIPANTS | |
| OTHER_PRE_SPECIFIED | Intensive Care Unit (ICU) Mortality | Enrollment until ICU discharge, death, or 30-days. Whichever comes first. | Participants | COUNT_OF_PARTICIPANTS | |
| OTHER_PRE_SPECIFIED | Number of Participants With Delirium | On day 3 (at approximately 72 hours) after the first study drug dose | 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) | Participants | COUNT_OF_PARTICIPANTS |
| OTHER_PRE_SPECIFIED | Hospital Disposition: Survivors Discharged Home | Enrollment until hospital discharge, death, or 30-days, whichever comes first. | Population of patients who survived to hospital discharge. 73 patients in the treatment group and 76 patients in the control group survived to hospital discharge.. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group22
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Sequential Organ Failure Assessment (SOFA) Score at Baseline and 72 Hours | Vitamin C, Vitamin B1, Corticosteroids | Enrollment SOFA score | 9.1 | Standard Deviation 3.5 | Units on a scale |
| Sequential Organ Failure Assessment (SOFA) Score at Baseline and 72 Hours | Placebo | Enrollment SOFA score | 9.2 | Standard Deviation 3.2 | Units on a scale |
| Sequential Organ Failure Assessment (SOFA) Score at Baseline and 72 Hours | Vitamin C, Vitamin B1, Corticosteroids | 72 hour SOFA score | 4.4 | Standard Deviation 4.1 | Units on a scale |
| Sequential Organ Failure Assessment (SOFA) Score at Baseline and 72 Hours | Placebo | 72 hour SOFA score | 5.1 | Standard Deviation 4.3 | Units on a scale |
| Renal Failure | Vitamin C, Vitamin B1, Corticosteroids | 32 | Participants | ||
| Renal Failure | Placebo | 27 | Participants | ||
| 30-day Mortality | Vitamin C, Vitamin B1, Corticosteroids | 35 | Participants | ||
| 30-day Mortality | Placebo | 29 | Participants | ||
| Ventilator Free Days | Vitamin C, Vitamin B1, Corticosteroids | 6 | Inter-Quartile Range 2 to 7 | Days | |
| Ventilator Free Days | Placebo | 6 | Inter-Quartile Range 0 to 7 | Days |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Vitamin C, Vitamin B1, Corticosteroids | 103 | |
| Overall Study | STARTED | Placebo | 102 | |
| Overall Study | COMPLETED | Vitamin C, Vitamin B1, Corticosteroids | 101 | |
| Overall Study | COMPLETED | Placebo | 99 | |
| Overall Study | NOT COMPLETED | Vitamin C, Vitamin B1, Corticosteroids | 2 | |
| Overall Study | NOT COMPLETED | Placebo | 3 |
Source ClinicalTrials.gov
Adverse events6
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 |
|---|---|---|---|---|---|---|
| serious | Hyperglycemia | Endocrine disorders | Vitamin C, Vitamin B1, Corticosteroids | 12 | 101 | 101 |
| serious | Hyperglycemia | Endocrine disorders | Placebo | 7 | 99 | 99 |
| serious | Hypernatremia | Metabolism and nutrition disorders | Vitamin C, Vitamin B1, Corticosteroids | 11 | 101 | 101 |
| serious | Hypernatremia | Metabolism and nutrition disorders | Placebo | 7 | 99 | 99 |
| serious | New Hospital Acquired Infection | Infections and infestations | Vitamin C, Vitamin B1, Corticosteroids | 13 | 101 | 101 |
| serious | New Hospital Acquired Infection | Infections and infestations | Placebo | 12 | 99 | 99 |
Source ClinicalTrials.gov
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Vitamin C, Vitamin B1, Corticosteroids | 35 | 101 |
| Total, all-cause mortality | Placebo | 29 | 99 |
| Total, other adverse events | Vitamin C, Vitamin B1, Corticosteroids | 0 | 101 |
| Total, other adverse events | Placebo | 0 | 99 |
| Total, serious adverse events | Vitamin C, Vitamin B1, Corticosteroids | 13 | 101 |
| Total, serious adverse events | Placebo | 12 | 99 |
Source ClinicalTrials.gov
Papers7
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 comparisons8
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Vitamin C, Vitamin B1, Corticosteroids vs Placebo: Intensive Care Unit (ICU) Mortality | Trial comparisons |
| Vitamin C, Vitamin B1, Corticosteroids vs Placebo: Hospital Disposition: Survivors Discharged Home | Trial comparisons |
| Vitamin C, Vitamin B1, Corticosteroids vs Placebo: 30-day Mortality | Trial comparisons |
| Vitamin C, Vitamin B1, Corticosteroids vs Placebo: Renal Failure | Trial comparisons |
| Vitamin C, Vitamin B1, Corticosteroids vs Placebo: Number of Participants With Delirium | Trial comparisons |
| Vitamin C, Vitamin B1, Corticosteroids vs Placebo: Hospital Mortality | Trial comparisons |
| Vitamin C, Vitamin B1, Corticosteroids vs Placebo: deaths from any cause | Trial comparisons |
| Vitamin C, Vitamin B1, Corticosteroids vs Placebo: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
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/NCT03389555
GET https://conductscience.org/api/trials/v1/NCT03389555/results?page=2