Trial · NCT02106975

Vitamin C Infusion for Treatment in Sepsis Induced Acute Lung Injury

NCT02106975, Phase 2, Completed, Virginia Commonwealth University; results first posted 2019-10-15

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Vitamin C Infusion for Treatment in Sepsis Induced Acute Lung Injury. Trials, record NCT02106975. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02106975

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Trial

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

Title: Vitamin C Infusion for Treatment in Sepsis Induced Acute Lung Injury
NCT number: NCT02106975
Status: Completed
Phases: Phase 2
Enrollment: 170 participants, actual
Lead sponsor: Virginia Commonwealth University
Conditions: Acute Lung Injury, Sepsis
Interventions: Ascorbic Acid, Placebo: 5% Dextrose in water
First posted: 2014-04-08
Last updated: 2019-10-15
Results first posted: 2019-10-15

Source ClinicalTrials.gov

Registered outcomes21

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

List	Outcome	Time frame	Description
Primary	Modified Change in Sequential Organ Failure Assessment (mSOFA) Score	96 hours	mSOFA is a single score based on patient status of five different biological systems: respiratory, cardiovascular, coagulation, renal, and neurological. Scores range from 0 to 20 with higher scores indicated worse status.
Primary	C-Reactive Protein at Study Hours 0, 48, 96, 168 When Compared to Placebo	up to 168 hours
Primary	Thrombomodulin Protein at Study Hours 0, 48, 96, 168 When Compared to Placebo	Up to 168 hours
Secondary	Oxygenation Index (FiO2 x Mean Airway Pressure/PaO2) at Study Hour 0, 48, 96, 168 if Still Intubated in Ascorbate Infused Patient Compared to Placebo.	Up to hour 168
Secondary	VE-40 (Vent RR x TV/Weight) x (PaCO2/40) at Study Hour 0, 48, 96, 168 if Still Intubated, in Ascorbate Infused Patient Compared to Placebo	Up to hour 168	Estimate of Shunt
Secondary	mSOFA Scores at Hours 0, 48, 96	Up to hour 96	mSOFA is a single score based on patient status of five different biological systems: respiratory, cardiovascular, coagulation, renal, and neurological. Scores range from 0 to 20 with higher scores indicated worse status.
Secondary	Ascorbate Level at Hour 0, 48, 96, 168	Up to hour 168
Secondary	Ventilator Free Days to Day 28	Up to Day 28
Secondary	ICU-free Days at Day 28	Up to Day 28
Secondary	All Cause Mortality to Day 28	Up to Day 28

1 to 10 of 21Source ClinicalTrials.gov

See all 21 registered outcomes

Outcomes21

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Modified Change in Sequential Organ Failure Assessment (mSOFA) Score	96 hours	3 participants were omitted from the analysis because the etiology of the patients SEPSIS was not representative of the typical SEPSIS patient	score on a scale	MEAN
PRIMARY	C-Reactive Protein at Study Hours 0, 48, 96, 168 When Compared to Placebo	up to 168 hours	3 participants were omitted from the analysis because the etiology of the patients SEPSIS was not representative of the typical SEPSIS patient	µg/ml	MEAN
PRIMARY	Thrombomodulin Protein at Study Hours 0, 48, 96, 168 When Compared to Placebo	Up to 168 hours		ng/ml	MEAN
SECONDARY	Oxygenation Index (FiO2 x Mean Airway Pressure/PaO2) at Study Hour 0, 48, 96, 168 if Still Intubated in Ascorbate Infused Patient Compared to Placebo.	Up to hour 168	3 participants were omitted from the analysis because the etiology of the patients SEPSIS was not representative of the typical SEPSIS patient	Index	MEAN
SECONDARY	VE-40 (Vent RR x TV/Weight) x (PaCO2/40) at Study Hour 0, 48, 96, 168 if Still Intubated, in Ascorbate Infused Patient Compared to Placebo	Up to hour 168	3 participants were omitted from the analysis because the etiology of the patients SEPSIS was not representative of the typical SEPSIS patient	mmMercury	MEAN
SECONDARY	mSOFA Scores at Hours 0, 48, 96	Up to hour 96	3 participants were omitted from the analysis because the etiology of the patients SEPSIS was not representative of the typical SEPSIS patient	units on a scale	MEDIAN
SECONDARY	Ascorbate Level at Hour 0, 48, 96, 168	Up to hour 168	3 participants were omitted from the analysis because the etiology of the patients SEPSIS was not representative of the typical SEPSIS patient	µM	MEAN
SECONDARY	Ventilator Free Days to Day 28	Up to Day 28	3 participants were omitted from the analysis because the etiology of the patients SEPSIS was not representative of the typical SEPSIS patient	days	MEAN
SECONDARY	ICU-free Days at Day 28	Up to Day 28	3 participants were omitted from the analysis because the etiology of the patients SEPSIS was not representative of the typical SEPSIS patient	days	MEAN
SECONDARY	All Cause Mortality to Day 28	Up to Day 28	3 participants were omitted from the analysis because the etiology of the patients SEPSIS was not representative of the typical SEPSIS patient	percentage of participants	NUMBER

1 to 10 of 21Source ClinicalTrials.gov

See all 21 outcomes

Results by group136

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

Outcome	Group	Category	Value	Spread	Units
Modified Change in Sequential Organ Failure Assessment (mSOFA) Score	Ascorbic Acid		-2.96	Standard Deviation 4.20	score on a scale
Modified Change in Sequential Organ Failure Assessment (mSOFA) Score	5% Dextrose in Water		-3.20	Standard Deviation 3.30	score on a scale
C-Reactive Protein at Study Hours 0, 48, 96, 168 When Compared to Placebo	Ascorbic Acid	0 hours	109	Standard Deviation 76	µg/ml
C-Reactive Protein at Study Hours 0, 48, 96, 168 When Compared to Placebo	5% Dextrose in Water	0 hours	119	Standard Deviation 67	µg/ml
C-Reactive Protein at Study Hours 0, 48, 96, 168 When Compared to Placebo	Ascorbic Acid	48 hours	80	Standard Deviation 66	µg/ml
C-Reactive Protein at Study Hours 0, 48, 96, 168 When Compared to Placebo	5% Dextrose in Water	48 hours	84	Standard Deviation 52	µg/ml
C-Reactive Protein at Study Hours 0, 48, 96, 168 When Compared to Placebo	Ascorbic Acid	96 hours	56	Standard Deviation 51	µg/ml
C-Reactive Protein at Study Hours 0, 48, 96, 168 When Compared to Placebo	5% Dextrose in Water	96 hours	59	Standard Deviation 52	µg/ml
C-Reactive Protein at Study Hours 0, 48, 96, 168 When Compared to Placebo	Ascorbic Acid	168 hours	54	Standard Deviation 48	µg/ml
C-Reactive Protein at Study Hours 0, 48, 96, 168 When Compared to Placebo	5% Dextrose in Water	168 hours	46	Standard Deviation 33	µg/ml

1 to 10 of 136Source ClinicalTrials.gov

See all 136 results by group

Participant flow6

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Ascorbic Acid	84
Overall Study	STARTED	5% Dextrose in Water	83
Overall Study	COMPLETED	Ascorbic Acid	59
Overall Study	COMPLETED	5% Dextrose in Water	44
Overall Study	NOT COMPLETED	Ascorbic Acid	25
Overall Study	NOT COMPLETED	5% Dextrose in Water	39

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	Ascorbic Acid	25	84
Total, all-cause mortality	5% Dextrose in Water	38	83
Total, other adverse events	Ascorbic Acid	0	84
Total, other adverse events	5% Dextrose in Water	0	83
Total, serious adverse events	Ascorbic Acid	0	84
Total, serious adverse events	5% Dextrose in Water	0	83

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
31573637	DERIVED

Source PubMed

Grants1

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.

Project	Title	Principal investigators	Organization	Funder	Fiscal years
UM1HL116885	Vitamin C Infusion for Treatment in Sepsis Induced Acute Lung Injury (CITRIS-ALI)	FOWLER, ALPHA ALSBURY; HITE, ROBERT DUNCAN; MARTIN, GREGORY S; TRUWIT, JONATHON D	VIRGINIA COMMONWEALTH UNIVERSITY	NATIONAL HEART, LUNG, AND BLOOD INSTITUTE	2013 to 2016

Source NIH RePORTER

Trial comparisons2

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

Comparison	Source
Ascorbic Acid vs 5% Dextrose in Water: deaths from any cause	Trial comparisons
Ascorbic Acid vs 5% Dextrose in Water: 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/NCT02106975

GET https://conductscience.org/api/trials/v1/NCT02106975/registered?page=2

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