Trial · NCT03338569

Vitamin C and Septic Shock

NCT03338569, Phase 2, Phase 3, Completed, University of Minnesota; results first posted 2021-07-14

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Vitamin C and Septic Shock. Trials, record NCT03338569. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03338569

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Vitamin C and Septic Shock
NCT number: NCT03338569
Status: Completed
Phases: Phase 2, Phase 3
Enrollment: 125 participants, actual
Lead sponsor: University of Minnesota
Conditions: Septic Shock, Sepsis
Interventions: Vitamin C, Placebo
First posted: 2017-11-09
Last updated: 2021-07-14
Results first posted: 2021-07-14

Source ClinicalTrials.gov

Registered outcomes12

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Number of Participants With ICU Mortality	28 days	Outcome is reported as the number of patients who expired while receiving care in the intensive care unit (ICU).
Primary	All Cause Mortality at 28 Days	28 days	Outcome is reported as the number of participants who have expired at 28 days post intervention
Secondary	Duration of Vasopressor Therapy	28 days	Outcome is reported as the duration in hours of vasopressor therapy post intervention administration
Secondary	Duration of ICU Stay Post Intervention Administration	28 days	Outcome is reported as the duration (in days) that participants require care in the intensive care unit (ICU) post intervention administration
Secondary	Time to Lactate Clearance Post Intervention Administration	28 days
Secondary	Rate of Lactate Clearance Post Intervention Administration	24, 48, 72, and 96 hours post intervention	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.
Secondary	Rate of Procalcitonin Clearance Post Intervention Administration	4 days
Secondary	Number of Participants With Need for Renal Replacement Therapy	4 days	Outcome is reported as the number of participants who require renal replacement therapy
Secondary	Change in Serum Creatinine	Baseline and 4 days	Outcome is report as the change in serum creatinine between baseline and 4 days following treatment. Outcome is reported in units of mg/dl.
Secondary	Change in Sequential Organ Failure Assessment (SOFA) Score	Baseline and 4 days	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.

1 to 10 of 12Source ClinicalTrials.gov

See all 12 registered outcomes

Outcomes12

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Number of Participants With ICU Mortality	28 days		Participants	COUNT_OF_PARTICIPANTS
PRIMARY	All Cause Mortality at 28 Days	28 days		Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Duration of Vasopressor Therapy	28 days		hours	MEDIAN
SECONDARY	Duration of ICU Stay Post Intervention Administration	28 days		days	MEAN
SECONDARY	Time to Lactate Clearance Post Intervention Administration	28 days	Measure was not collected
SECONDARY	Rate of Lactate Clearance Post Intervention Administration	24, 48, 72, and 96 hours post intervention	All participants who completed 96 hours of testing are included.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Rate of Procalcitonin Clearance Post Intervention Administration	4 days	Outcome was not collected.
SECONDARY	Number of Participants With Need for Renal Replacement Therapy	4 days		Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Change in Serum Creatinine	Baseline and 4 days	All participants for whom baseline and 96-hour creatinine data is available are included in this analysis.	mg/dl	MEDIAN
SECONDARY	Change in Sequential Organ Failure Assessment (SOFA) Score	Baseline and 4 days	All participants for whom baseline and 96-hour SOFA scores were available are included in this analysis.	score on a scale	MEDIAN

1 to 10 of 12Source ClinicalTrials.gov

See all 12 outcomes

Results by group28

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Number of Participants With ICU Mortality	Placebo		20		Participants
Number of Participants With ICU Mortality	Intervention		14		Participants
All Cause Mortality at 28 Days	Placebo		26		Participants
All Cause Mortality at 28 Days	Intervention		16		Participants
Duration of Vasopressor Therapy	Placebo		27.1	Inter-Quartile Range 16.4 to 45.2	hours
Duration of Vasopressor Therapy	Intervention		27.7	Inter-Quartile Range 13.6 to 47.6	hours
Duration of ICU Stay Post Intervention Administration	Placebo		2.6	Inter-Quartile Range 1.5 to 5.3	days
Duration of ICU Stay Post Intervention Administration	Intervention		2.9	Inter-Quartile Range 1.8 to 7.5	days
Rate of Lactate Clearance Post Intervention Administration	Placebo	24 hours	13		Participants
Rate of Lactate Clearance Post Intervention Administration	Intervention	24 hours	12		Participants

1 to 10 of 28Source ClinicalTrials.gov

See all 28 results by group

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Placebo	64
Overall Study	STARTED	Intervention	61
Overall Study	COMPLETED	Placebo	56
Overall Study	COMPLETED	Intervention	56
Overall Study	NOT COMPLETED	Placebo	8
Overall Study	NOT COMPLETED	Intervention	5

Source ClinicalTrials.gov

Adverse events30

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	Loose stools	Gastrointestinal disorders	Placebo	1	64	1
other	Loose stools	Gastrointestinal disorders	Intervention	0	61	0
other	Nausea	Gastrointestinal disorders	Placebo	0	64	0
other	Nausea	Gastrointestinal disorders	Intervention	1	61	1
other	Dysphagia	Gastrointestinal disorders	Placebo	0	64	0
other	Dysphagia	Gastrointestinal disorders	Intervention	1	61	1
other	New or worsening heart failure	Cardiac disorders	Placebo	1	64	1
other	New or worsening heart failure	Cardiac disorders	Intervention	0	61	0
other	Arrythmia	Cardiac disorders	Placebo	3	64	3
other	Arrythmia	Cardiac disorders	Intervention	4	61	7

1 to 10 of 30Source ClinicalTrials.gov

See all 30 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Placebo	26	64
Total, all-cause mortality	Intervention	16	61
Total, other adverse events	Placebo	9	64
Total, other adverse events	Intervention	8	61
Total, serious adverse events	Placebo	3	64
Total, serious adverse events	Intervention	4	61

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
34982738	DERIVED

Source PubMed

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 comparisons5

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison	Source
Intervention vs Placebo: Number of Participants With ICU Mortality	Trial comparisons
Intervention vs Placebo: Number of Participants With Need for Renal Replacement Therapy	Trial comparisons
Intervention vs Placebo: All Cause Mortality at 28 Days	Trial comparisons
Intervention vs Placebo: deaths from any cause	Trial comparisons
Intervention 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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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/NCT03338569

GET https://conductscience.org/api/trials/v1/NCT03338569/results?page=2

API reference For AI assistants