A Phase 2/3 interventional study of Vitamin C and Placebo in Septic Shock and Sepsis, sponsored by University of Minnesota. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-07-14.
Sponsored by University of Minnesota · Phase 2/3, Interventional, and Treatment
Among 23 studies testing Ascorbic Acid in Shock, Septic — 2 open to participants now, 2 under way, none of them phase 3. Ascorbic Acid · Shock, Septic.
Among the 23 studies testing Ascorbic Acid in Shock, Septic, this one is the 8th largest by enrollment, is one of 2 that started in 2017, is one of 2 in phase 2/3, and was the 4th registered.
1,078 studies on the registry are indexed under Shock, Septic; 232 are open to participants now.
Browse Shock, Septic studies →2 of the 23 studies testing Ascorbic Acid in Shock, Septic are open now, in 1 country. Recruiting first, the newest first:
Fan Zeng · Sites in China
Ages 18–85
Institute of Liver and Biliary Sciences, India
Ages 18+
By country, each count listing its studies:
Ascorbic Acid: first FDA approval 1947 (BEROCCA PN). What it is approved for, and how studies give it, is on its page →
Of the 136 Shock, Septic studies recruiting now, 102 (75%) set no upper age limit and 19 (14%) stop at 75 or younger; 12 take children under 18; 13 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
23 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 2 · Phase 2 9 · Phase 3 7 · Phase 4 3
First in 2010; this study’s year is marked. 2 started in 2017.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 125 is above the median of 79 across 636 interventional studies indexed under Shock, Septic.
Median enrollment 71 across the 23 interventional studies. Of the 18 that completed or were terminated, 5 (28%) have results posted.
This tab as a report to print or save as PDF → With an account.
None of the 23 has an industry lead sponsor. The 10 most frequent:
University of Minnesota is the lead sponsor of 1,216 studies on the registry; 196 are open to participants now.
Of its 136 completed or terminated interventional studies of FDA-regulated products, 95 (70%) have results posted.
University of Minnesota has 2 studies filed under Shock, Septic — fewer than ten, so there is no comparison to draw.
1 of the studies testing Ascorbic Acid in Shock, Septic that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07184866Institute of Liver and Biliary Sciences, IndiaVitamin C for Acute Kidney Injury in ACLF With Septic Shock: A Randomized Controlled Trial | 2027-07 |
Add it to your calendar (.ics) → With an account.
Among the 23 studies testing Ascorbic Acid in Shock, Septic, from their registry updates:
Nothing recorded among them since 2026-09-25.
This tab as a report to print or save as PDF → With an account.
This is a randomized, double-blind, placebo-controlled clinical trial to compare Vitamin C versus placebo for patients presenting to the ICU with a diagnosis of septic shock.
This is a multi-site, randomized, double-blind, placebo-controlled trial comparing a regimen of moderate-dose (6000 mg per day) Vitamin C supplementation versus placebo for the treatment of patients presenting to the ICU with septic shock. Both groups will continue to receive all other standard of care measures for septic shock as clinically indicated. Groups will be enrolled and receive study drug/placebo for 4 days (96 hours) or until 24 hours post-last pressor dose, whichever is sooner.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Capability to provide written consent from participant or legally authorized representative (LAR) if the participant is unable or incapacitated due to severity of illness.
Septic shock as pragmatically defined as:
o Order for intravenous antimicrobials with either procalcitonin > 2 mg/dL within 24 hours of enrollment OR other clinical suspicion of infection or confirmed infection AND
Presence of sepsis defined as equal to or greater than 2 SIRS criteria and/or acute increase in qSOFA score of 2 points or more.
Exclusion Criteria:
Unable to start infusion within 24 hours of septic shock identification
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Placebo designed to mimic intervention
Drug: Placebo
6000 mg per day Vitamin C supplement
Drug: Vitamin C
Continuous infusion of vitamin C
Also known as: ascorbic acid
Placebo designed to mimic intervention
Number of Participants With ICU Mortality
Outcome is reported as the number of patients who expired while receiving care in the intensive care unit (ICU).
Time frame: 28 days
All Cause Mortality at 28 Days
Outcome is reported as the number of participants who have expired at 28 days post intervention
Time frame: 28 days
Duration of Vasopressor Therapy
Outcome is reported as the duration in hours of vasopressor therapy post intervention administration
Time frame: 28 days
Duration of ICU Stay Post Intervention Administration
Outcome is reported as the duration (in days) that participants require care in the intensive care unit (ICU) post intervention administration
Time frame: 28 days
Time to Lactate Clearance Post Intervention Administration
Time frame: 28 days
Rate of Lactate Clearance Post Intervention Administration
Outcome is reported as the number of participants who clear lactate from the bloodstream at 24, 48, 72, and 96 hours post intervention. Clearance is defined as a serum concentration of 2.0 mmol/l or less.
Time frame: 24, 48, 72, and 96 hours post intervention
Rate of Procalcitonin Clearance Post Intervention Administration
Time frame: 4 days
Number of Participants With Need for Renal Replacement Therapy
Outcome is reported as the number of participants who require renal replacement therapy
Time frame: 4 days
Change in Serum Creatinine
Outcome is report as the change in serum creatinine between baseline and 4 days following treatment. Outcome is reported in units of mg/dl.
Time frame: Baseline and 4 days
Change in Sequential Organ Failure Assessment (SOFA) Score
SOFA score is a mortality prediction score that is based on the degree of dysfunction of 6 organ systems. Total scores range from 0 to 24, with higher scores indicating higher likely mortality.
Time frame: Baseline and 4 days
Change in Acute Physiology and Chronic Health Evaluation (APACHE) Scores
APACHE score is a severity-of-disease classification system that is calculated from a patient's age and 12 routine physiological measurements. Total scores are computed based on several measurements and range from 0 to 71 with higher scores corresponding to more severe disease and a higher risk of death.
Time frame: Baseline and 4 days
Total Intravenous Fluid Administered
Outcome is reported as the total volume of intravenous fluid (in liters) administered to participants during 24 hours following the initiation of study treatment.
Time frame: 24 hours
| Milestone | Placebo | Intervention |
|---|---|---|
| Started | 64 | 61 |
| Completed | 56 | 56 |
| Not completed | 8 | 5 |
| Withdrew: Physician decision | 8 | 3 |
| Withdrew: Withdrawal by subject | 0 | 1 |
| Withdrew: Lost to follow-up | 0 | 1 |
Outcome is reported as the number of patients who expired while receiving care in the intensive care unit (ICU).
| Participants | Placebo | Intervention |
|---|---|---|
| Number of Participants With ICU Mortality | 20 | 14 |
Outcome is reported as the number of participants who have expired at 28 days post intervention
| Participants | Placebo | Intervention |
|---|---|---|
| All Cause Mortality at 28 Days | 26 | 16 |
Outcome is reported as the duration in hours of vasopressor therapy post intervention administration
| hours | Placebo | Intervention |
|---|---|---|
| Duration of Vasopressor Therapy | 27.1 (16.4 to 45.2) | 27.7 (13.6 to 47.6) |
Outcome is reported as the duration (in days) that participants require care in the intensive care unit (ICU) post intervention administration
| days | Placebo | Intervention |
|---|---|---|
| Duration of ICU Stay Post Intervention Administration | 2.6 (1.5 to 5.3) | 2.9 (1.8 to 7.5) |
No measurements were reported for this outcome.
Outcome is reported as the number of participants who clear lactate from the bloodstream at 24, 48, 72, and 96 hours post intervention. Clearance is defined as a serum concentration of 2.0 mmol/l or less.
| Participants | Placebo | Intervention |
|---|---|---|
| 24 hours | 13 | 12 |
| 48 hours | 18 | 16 |
| 72 hours | 18 | 18 |
| 96 hours | 19 | 18 |
No measurements were reported for this outcome.
Outcome is reported as the number of participants who require renal replacement therapy
| Participants | Placebo | Intervention |
|---|---|---|
| Number of Participants With Need for Renal Replacement Therapy | 2 | 10 |
Outcome is report as the change in serum creatinine between baseline and 4 days following treatment. Outcome is reported in units of mg/dl.
| mg/dl | Placebo | Intervention |
|---|---|---|
| Change in Serum Creatinine | 0.5 (-0.1 to 0.7) | .4 (0 to 0.7) |
SOFA score is a mortality prediction score that is based on the degree of dysfunction of 6 organ systems. Total scores range from 0 to 24, with higher scores indicating higher likely mortality.
| score on a scale | Placebo | Intervention |
|---|---|---|
| Change in Sequential Organ Failure Assessment (SOFA) Score | 4 (2 to 6) | 4 (2 to 6) |
APACHE score is a severity-of-disease classification system that is calculated from a patient's age and 12 routine physiological measurements. Total scores are computed based on several measurements and range from 0 to 71 with higher scores corresponding to more severe disease and a higher risk of death.
| score on a scale | Placebo | Intervention |
|---|---|---|
| Change in Acute Physiology and Chronic Health Evaluation (APACHE) Scores | 7 (1 to 12) | 5 (3 to 10) |
Outcome is reported as the total volume of intravenous fluid (in liters) administered to participants during 24 hours following the initiation of study treatment.
| liters | Placebo | Intervention |
|---|---|---|
| 6 hours post initiation of study treatment | .76 (.36 to 1.26) | 1.07 (.72 to 1.64) |
| 24 hours post initiation of study treatment | 3.37 (1.98 to 4.7) | 3.59 (2.52 to 5.02) |
Collected over 28 days. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Placebo | 26/64 (40.6%) | 3/64 (4.7%) | 9/64 (14.1%) |
| Intervention | 16/61 (26.2%) | 4/61 (6.6%) | 8/61 (13.1%) |
| Event | Placebo | Intervention |
|---|---|---|
| Elevated Troponin w/o ST elevationCardiac disorders | 0/64 | 2/61 |
| New or worsening heart failureCardiac disorders | 2/64 | 0/61 |
| BleedingBlood and lymphatic system disorders | 0/64 | 1/61 |
| PancytopeniaBlood and lymphatic system disorders | 0/64 | 1/61 |
| ArrythmiaCardiac disorders | 1/64 | 0/61 |
| Event | Placebo | Intervention |
|---|---|---|
| ArrythmiaCardiac disorders | 3/64 | 4/61 |
| NauseaGastrointestinal disorders | 0/64 | 1/61 |
| DysphagiaGastrointestinal disorders | 0/64 | 1/61 |
| ThrombocytopeniaBlood and lymphatic system disorders | 1/64 | 1/61 |
| Maculopapular rashSkin and subcutaneous tissue disorders | 0/64 | 1/61 |
| Loose stoolsGastrointestinal disorders | 1/64 | 0/61 |
| New or worsening heart failureCardiac disorders | 1/64 | 0/61 |
| Elevated Troponin w/o ST elevationCardiac disorders | 1/64 | 0/61 |
| Pleural EffusionRespiratory, thoracic and mediastinal disorders | 1/64 | 0/61 |
| Bleeding eventBlood and lymphatic system disorders | 1/64 | 0/61 |
| Age, Continuous(years) | Placebo | Intervention | Total |
|---|---|---|---|
| Mean | 73 (60.7 to 80) | 68.9 (60.1 to 79.9) | 71 (60.1 to 80) |
| Sex: Female, Male(Participants) | Placebo | Intervention | Total |
|---|---|---|---|
| Female | 31 | 31 | 62 |
| Male | 33 | 30 | 63 |
| Race (NIH/OMB)(Participants) | Placebo | Intervention | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 2 | 2 | 4 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 2 | 0 | 2 |
| White | 59 | 59 | 118 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 1 | 0 | 1 |
| Region of Enrollment(participants) | Placebo | Intervention | Total |
|---|---|---|---|
| United States | 64 | 61 | 125 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Undecided
Ran from Dec 2017 to primary completion in Jun 2020, 30 months.
Results were first posted in Jul 2021, 1 year after primary completion.
Of 13 phase 2/3 interventional studies under Shock, Septic, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 40. This study's 30 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jul 2021. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Ascorbic Acid