Trial · NCT03422159
Metabolic Resuscitation Using Ascorbic Acid, Thiamine, and Glucocorticoids in Sepsis.
NCT03422159, Phase 2, Completed, Community Medical Center, Toms River, NJ; results first posted 2021-09-21
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Metabolic Resuscitation Using Ascorbic Acid, Thiamine, and Glucocorticoids in Sepsis. Trials, record NCT03422159. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03422159
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Metabolic Resuscitation Using Ascorbic Acid, Thiamine, and Glucocorticoids in Sepsis.
- NCT number
- NCT03422159
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 140 participants, actual
- Lead sponsor
- Community Medical Center, Toms River, NJ
- Conditions
- Sepsis, Severe, Septic Shock
- Interventions
- Ascorbic Acid, Thiamine, Hydrocortisone, Sodium Chloride 0.9%
- First posted
- 2018-02-05
- Last updated
- 2021-09-21
- Results first posted
- 2021-09-21
- Limitations and caveats
- The relative weakness was its small, homogenous (primarily caucasian) cohort size, limiting the ability to detect differences in hospital mortality and length of stay.
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Time to Vasopressor Independence (Hours) | From start of vasopressor medication to final discontinuation of vasopressor medication, up to 7 days. | Defined as the time from starting the active treatment/placebo to discontinuation of all pressors. |
| Primary | Change in Sequential Organ Failure Assessment (SOFA) Score | 4 days post-randomization | Defined as the day 4 post-randomization SOFA score minus the initial SOFA score. The Sequential Organ Failure Assessment (SOFA) Score is a mortality prediction score that is based on the degree of dysfunction of six organ systems. The score is calculated on admission and every 24 hours until discharge using the worst parameters measured during the prior 24 hours SOFA score ranges from 0 (no organ dysfunction) to 24 (highest possible score / organ dysfunction). |
| Secondary | Procalcitonin (PCT) Clearance | 4 days post-randomization | PCT at 96 hours minus initial PCT, divided by the initial PCT multiplied by 100. |
| Secondary | ICU Mortality | From admission to hospital until final discharge from the ICU, up to 28 days. | ICU mortality rate |
| Secondary | ICU Length of Stay | From admission to the ICU until final discharge from the ICU, up to an average of 7 days. | Time from admitting to ICU to discharge. |
| Secondary | Ventilator Free Days | 28 Days post-randomization | Number of days alive and off of the ventilator at day 28. |
| Secondary | Hospital Length of Stay | From admission to the hospital until final discharge, up to 28 days. | Time from admitting to discharge of hospital stay. |
| Secondary | Hospital Mortality | Survival until hospital discharge, up to 28 days. | In-hospital mortality rate. |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Time to Vasopressor Independence (Hours) | From start of vasopressor medication to final discontinuation of vasopressor medication, up to 7 days. | Patients on vasopressor therapy in each group. | hours | MEAN |
| PRIMARY | Change in Sequential Organ Failure Assessment (SOFA) Score | 4 days post-randomization | score on a scale | MEAN | |
| SECONDARY | Procalcitonin (PCT) Clearance | 4 days post-randomization | Percent | MEAN | |
| SECONDARY | ICU Mortality | From admission to hospital until final discharge from the ICU, up to 28 days. | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | ICU Length of Stay | From admission to the ICU until final discharge from the ICU, up to an average of 7 days. | days | MEAN | |
| SECONDARY | Ventilator Free Days | 28 Days post-randomization | Days | MEAN | |
| SECONDARY | Hospital Length of Stay | From admission to the hospital until final discharge, up to 28 days. | Days | MEAN | |
| SECONDARY | Hospital Mortality | Survival until hospital discharge, up to 28 days. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group16
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Time to Vasopressor Independence (Hours) | HAT Treatment | 27 | Standard Deviation 22 | hours | |
| Time to Vasopressor Independence (Hours) | Comparator | 53 | Standard Deviation 38 | hours | |
| Change in Sequential Organ Failure Assessment (SOFA) Score | Treatment Arm | 2.9 | Standard Deviation 3.3 | score on a scale | |
| Change in Sequential Organ Failure Assessment (SOFA) Score | Placebo Arm | 1.93 | Standard Deviation 3.5 | score on a scale | |
| Procalcitonin (PCT) Clearance | Treatment Arm | 63 | Standard Deviation 170 | Percent | |
| Procalcitonin (PCT) Clearance | Placebo Arm | 58 | Standard Deviation 66 | Percent | |
| ICU Mortality | Treatment Arm | 6 | Participants | ||
| ICU Mortality | Placebo Arm | 10 | Participants | ||
| ICU Length of Stay | Treatment Arm | 4.76 | Standard Deviation 4.3 | days | |
| ICU Length of Stay | Placebo Arm | 4.66 | Standard Deviation 3.45 | days |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 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 Arm | 70 | |
| Overall Study | STARTED | Placebo Arm | 70 | |
| Overall Study | COMPLETED | Treatment Arm | 68 | |
| Overall Study | COMPLETED | Placebo Arm | 69 | |
| Overall Study | NOT COMPLETED | Treatment Arm | 2 | |
| Overall Study | NOT COMPLETED | Placebo Arm | 1 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Treatment Arm | 11 | 68 |
| Total, all-cause mortality | Placebo Arm | 13 | 69 |
| Total, other adverse events | Treatment Arm | 0 | 68 |
| Total, other adverse events | Placebo Arm | 0 | 69 |
| Total, serious adverse events | Treatment Arm | 0 | 68 |
| Total, serious adverse events | Placebo Arm | 0 | 69 |
Source ClinicalTrials.gov
Papers68
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 comparisons4
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Treatment Arm vs Placebo Arm: ICU Mortality | Trial comparisons |
| Treatment Arm vs Placebo Arm: Hospital Mortality | Trial comparisons |
| Treatment Arm vs Placebo Arm: deaths from any cause | Trial comparisons |
| Treatment Arm vs Placebo Arm: 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/NCT03422159
GET https://conductscience.org/api/trials/v1/NCT03422159/papers?page=2