Acute Lung InjuryPhase 2CITRIS-ALINCT02106975

Vitamin C Infusion for Treatment in Sepsis Induced Acute Lung Injury

A Phase 2 study testing Ascorbic Acid in people with Acute Lung Injury and Sepsis, run by Virginia Commonwealth University at 5 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Hypothesis 1A: Vitamin C infusion will significantly attenuate sepsis-induced systemic organ failure as measured by Sequential Organ Failure Assessment (SOFA) score, Hypothesis 1B: Vitamin C infusion will attenuate sepsis-induced lung injury as assessed by the oxygenation index and the VE40 Hypothesis 1C: Vitamin C… Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Acute Lung Injury, Sepsis
What is being tested?: Ascorbic Acid
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 170 participants
Where: 5 sitesUnited States
Study dates: Apr 2014to 8 Jan 2018
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patients must have suspected or proven infection, and meet 2 out of 4 of the criteria for Systemic Inflammatory Response (SIRS) due to infection, and be accompanied by at least 1 criterion for sepsis-induced organ dysfunction, and meet all 5 criteria for Acute Respiratory Distress Syndrome (ARDS).
Suspected or proven infection: (e.g., thorax, urinary tract, abdomen, skin, sinuses, central venous catheters, and central nervous system, see Appendix A).
The presence of a systemic inflammatory response: Defined as: fever: >38ºC (any route) or hypothermia: <36ºC (core temp only), tachycardia: heart rate > 90 beats/min or receiving medications that slow heart rate or paced rhythm, leukocytosis: >12,000 WBC/µL or leukopenia: <4,000 WBC/µL or >10% band forms. Respiratory rate > 20 breaths per minute or PaCO2 < 32 or invasive mechanical ventilation.
The presence of sepsis associated organ dysfunction: (any of the following thought to be due to infection)
Sepsis associated hypotension (systolic blood pressure (SBP) < 90 mm Hg or an SBP decrease > 40 mm Hg unexplained by other causes or use of vasopressors for blood pressure support (epinephrine, norepinephrine, dopamine =/> 5mcg, phenylephrine, vasopressin)
Arterial hypoxemia (PaO2/FiO2 < 300) or supplemental O2 > 6LPM.

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Lactate > upper limits of normal laboratory results
Urine output < 0.5 ml/kg/hour for > two hours despite adequate fluid resuscitation
Platelet count < 100,000 per mcL
Coagulopathy (INR > 1.5)
Bilirubin > 2 mg/dL
Glasgow Coma Scale < 11 or a positive CAM ICU score
ARDS characterized by all the following criteria
Lung injury of acute onset, within 1 week of an apparent clinical insult and with progression of respiratory symptoms
Bilateral opacities on chest imaging not explained by other pulmonary pathology (e.g. pleural effusions, lung collapse, or nodules)
Respiratory failure not explained by heart failure or volume overload
Decreased arterial PaO2/FiO2 ratio ≤ 300 mm Hg
Minimum PEEP of 5 cmH2O (may be delivered noninvasively with CPAP to diagnose mild ARDS

Who cannot join

Known allergy to Vitamin C
inability to obtain consent;
age < 18 years;
No indwelling venous or arterial catheter in patients requiring insulin in a manner that requires glucose being checked more than twice daily (e.g. continuous infusion, sliding scale);
presence of diabetic ketoacidosis;
more than 48 hrs since meeting ARDS criteria;

Show all 16Show fewer

patient or surrogate or physician not committed to full support (not excluded if patient would receive all supportive care except for cardiac resuscitation);
pregnancy or breast feeding,
moribund patient not expected to survive 24 hours;
home mechanical ventilation (via tracheotomy or noninvasive) except for CPAP/BIPAP used only for sleep-disordered breathing;
home O2 > 2LPM, except for with CPAP/BIPAP
diffuse alveolar hemorrhage (vasculitis);
interstitial lung disease requiring continuous home oxygen therapy;
Active kidney stone
Non English speaking;
Ward of the state (inmate, other)

Trial locations and contacts

5 sites in 1 country.

City, postcode or hospital

5 sites in 1 country

United States5 sites

Emory University and Grady Memorial Hospital
Atlanta, Georgia, 30322
The Cleveland Clinic
Cleveland, Ohio, 44106
University of Kentucky
Lexington, Kentucky, 40506
Froedtert and The Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
Virginia Commonwealth University Health System
Richmond, Virginia, 23298

Other trials in United States

About this study

Hypothesis 1A: Vitamin C infusion will significantly attenuate sepsis-induced systemic organ failure as measured by Sequential Organ Failure Assessment (SOFA) score,

Hypothesis 1B: Vitamin C infusion will attenuate sepsis-induced lung injury as assessed by the oxygenation index and the VE40

Hypothesis 1C: Vitamin C infusion will attenuate biomarkers of inflammation (C-Reactive Protein, Procalcitonin), vascular injury (Thrombomodulin, Angiopoietin-2), alveolar epithelial injury (Receptor for Advanced Glycation Products), while inducing the onset of a fibrinolytic state (Tissue Factor Pathway Inhibitor).

Conditions: Acute Lung Injury, Sepsis
Being tested: Ascorbic Acid, Placebo: 5% Dextrose in water
Medical subject headings: Acute Lung Injury, Sepsis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Ascorbic AcidDrug
Also called Vitamin C
Intervention
Placebo: 5% Dextrose in waterDrug
Placebo

Study groups in NCT02106975
Study group	Role	What they receive
Ascorbic Acid	Active comparator	200mg/kg/day divided over 4 doses. Administered every 6 hours for 96 hours Receives: Drug: Ascorbic Acid
5% Dextrose in Water	Placebo comparator	50ml every 6 hours for 96 hours Receives: Drug: Placebo: 5% Dextrose in water

What is being measured

The primary outcome is the main question the study is designed to answer.

Modified Change in Sequential Organ Failure Assessment (mSOFA) Score
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.
Measured: 96 hours
C-Reactive Protein at Study Hours 0, 48, 96, 168 When Compared to Placebo
Measured: up to 168 hours
Thrombomodulin Protein at Study Hours 0, 48, 96, 168 When Compared to Placebo
Measured: Up to 168 hours

Secondary outcomes (18)

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.
Measured: Up to hour 168
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
Estimate of Shunt
Measured: Up to hour 168
mSOFA Scores at Hours 0, 48, 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.
Measured: Up to hour 96
Ascorbate Level at Hour 0, 48, 96, 168
Measured: Up to hour 168
Ventilator Free Days to Day 28
Measured: Up to Day 28
ICU-free Days at Day 28
Measured: Up to Day 28
All Cause Mortality to Day 28
Measured: Up to Day 28
Hospital-free Days at Day 60
Measured: Up to Day 60
Procalcitonin at Study Hour 0, 48, 96, 168
Measured: Up to hour 168
Receptor for Advanced Glycation Endpoints at Study Hour 0, 48, 96, 168
Measured: Up to hour 168
Tissue Factor Pathway Inhibitor at Study Hour 0, 48, 96, 168
Measured: Up to hour 168
Oxygenation Score: Pressure
Oxygenation as measure by the ratio of arterial oxygen partial pressure to fractional inspired oxygen (PaO2/FiO2). Scores range from 100 to 300 with lower values indicating more worse outcomes
Measured: Up to hour 168
Oxygenation Score: Saturation
Oxygenation as measure by the ratio of arterial oxygen saturation to fraction of inspired oxygen SpO2/FiO2
Measured: Up to hour 168
Coagulation
Coagulation as measured by Platelets per unit of blood. Scores range from less than 20 to more than 150. Lower scores indicate worse outcomes
Measured: Up to hour 168
Liver Function
Liver function as measured by Total Bilirubin. Normal levels range from 0.2 - 1.2. Levels greater than 1.2 indicate worse outcomes
Measured: Up to hour 168
Cardiovascular Function
Cardiovascular function as measured by Mean arterial pressure. Scores less than 70 mmHg indicate worse outcomes.
Measured: Up to hour 168
State of Consciousness
State of consciousness as measure by Glasgow Coma Scale which gives a score based on eye, verbal, and motor responses. Scores range from 3 to 15 with lower scores indicating worse outcome
Measured: Up to hour 168
Renal Function
Renal function as measured by Creatinine. Scores range from less than 1.2 to greater than 5.0 with higher scores indicating worse outcomes
Measured: Up to hour 168

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Apr 20148 Jan 2018

First posted8 Apr 2014 (estimated)
Study startApr 2014
Primary completion16 Nov 2017
Study completion8 Jan 2018

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Acute Lung InjuryStudies of the same condition, open and under way.
More trials run by Virginia Commonwealth UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 170 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02106975
Sponsor's protocol ID: HM20000917
Other IDs: 1UM1HL116885-01
Acronym: CITRIS-ALI
Status last verified: Oct 2019
First submitted: 27 Mar 2014
Last updated: 15 Oct 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

Fowler AA 3rd, Truwit JD, Hite RD, Morris PE, DeWilde C, Priday A, Fisher B, Thacker LR 2nd, Natarajan R, Brophy DF, Sculthorpe R, Nanchal R, Syed A, Sturgill J, Martin GS, Sevransky J, Kashiouris M, Hamman S, Egan KF, Hastings A, Spencer W, Tench S, Mehkri O, Bindas J, Duggal A, Graf J, Zellner S, Yanny L, McPolin C, Hollrith T, Kramer D, Ojielo C, Damm T, Cassity E, Wieliczko A, Halquist M. Effect of Vitamin C Infusion on Organ Failure and Biomarkers of Inflammation and Vascular Injury in Patients With Sepsis and Severe Acute Respiratory Failure: The CITRIS-ALI Randomized Clinical Trial. JAMA. 2019 Oct 1;322(13):1261-1270. doi: 10.1001/jama.2019.11825.
PubMed 31573637

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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All Acute Lung Injury trials

Study at a glance

From the registry record, last updated by the sponsor on 15 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Vitamin C Infusion for Treatment in Sepsis Induced Acute Lung Injury
ClinicalTrials.gov ID: NCT02106975
Acronym / sponsor ID: CITRIS-ALI / HM20000917
Conditions: Acute Lung Injury, Sepsis
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 170 participants (actual)
Lead sponsor: Virginia Commonwealth UniversityUniversity, hospital or other
Collaborators: National Heart, Lung, and Blood Institute (NHLBI)
Study start: Apr 2014
Primary completion: 16 Nov 2017 (actual)
Study completion: 8 Jan 2018 (actual)
First posted: 8 Apr 2014 (estimated)
Results: Posted 15 Oct 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Hypothesis 1A: Vitamin C infusion will significantly attenuate sepsis-induced systemic organ failure as measured by Sequential Organ Failure Assessment (SOFA) score,

Hypothesis 1B: Vitamin C infusion will attenuate sepsis-induced lung injury as assessed by the oxygenation index and the VE40

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind (participant, care provider, investigator, outcomes assessor)
Number of arms: 2

Arm	Type	Receives
Ascorbic Acid	Active comparator	Drug: Ascorbic Acid200mg/kg/day divided over 4 doses. Administered every 6 hours for 96 hours
5% Dextrose in Water	Placebo comparator	Drug: Placebo: 5% Dextrose in water50ml every 6 hours for 96 hours

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (18 listed)

Patients must have suspected or proven infection, and meet 2 out of 4 of the criteria for Systemic Inflammatory Response (SIRS) due to infection, and be accompanied by at least 1 criterion for sepsis-induced organ dysfunction, and meet all 5 criteria for Acute Respiratory Distress Syndrome (ARDS).
Suspected or proven infection: (e.g., thorax, urinary tract, abdomen, skin, sinuses, central venous catheters, and central nervous system, see Appendix A).
The presence of a systemic inflammatory response: Defined as: fever: >38ºC (any route) or hypothermia: <36ºC (core temp only), tachycardia: heart rate > 90 beats/min or receiving medications that slow heart rate or paced rhythm, leukocytosis: >12,000 WBC/µL or leukopenia: <4,000 WBC/µL or >10% band forms. Respiratory rate > 20 breaths per minute or PaCO2 < 32 or invasive mechanical ventilation.
The presence of sepsis associated organ dysfunction: (any of the following thought to be due to infection)
Sepsis associated hypotension (systolic blood pressure (SBP) < 90 mm Hg or an SBP decrease > 40 mm Hg unexplained by other causes or use of vasopressors for blood pressure support (epinephrine, norepinephrine, dopamine =/> 5mcg, phenylephrine, vasopressin)

Key exclusion criteria (16 listed)

Known allergy to Vitamin C
inability to obtain consent;
age < 18 years;
No indwelling venous or arterial catheter in patients requiring insulin in a manner that requires glucose being checked more than twice daily (e.g. continuous infusion, sliding scale);
presence of diabetic ketoacidosis;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Ascorbic AcidAlso: Vitamin CIntervention	Drug	Ascorbic Acid
Placebo: 5% Dextrose in waterPlacebo	Drug	5% Dextrose in Water

Primary outcome

Modified Change in Sequential Organ Failure Assessment (mSOFA) Score
Time frame: 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.
C-Reactive Protein at Study Hours 0, 48, 96, 168 When Compared to Placebo
Time frame: up to 168 hours
Thrombomodulin Protein at Study Hours 0, 48, 96, 168 When Compared to Placebo
Time frame: Up to 168 hours

18 secondary outcomes

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.
Time frame: Up to hour 168
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
Time frame: Up to hour 168
mSOFA Scores at Hours 0, 48, 96
Time frame: Up to hour 96
Ascorbate Level at Hour 0, 48, 96, 168
Time frame: Up to hour 168
Ventilator Free Days to Day 28
Time frame: Up to Day 28
ICU-free Days at Day 28
Time frame: Up to Day 28
All Cause Mortality to Day 28
Time frame: Up to Day 28
Hospital-free Days at Day 60
Time frame: Up to Day 60
Procalcitonin at Study Hour 0, 48, 96, 168
Time frame: Up to hour 168
Receptor for Advanced Glycation Endpoints at Study Hour 0, 48, 96, 168
Time frame: Up to hour 168
Tissue Factor Pathway Inhibitor at Study Hour 0, 48, 96, 168
Time frame: Up to hour 168
Oxygenation Score: Pressure
Time frame: Up to hour 168
Oxygenation Score: Saturation
Time frame: Up to hour 168
Coagulation
Time frame: Up to hour 168
Liver Function
Time frame: Up to hour 168
Cardiovascular Function
Time frame: Up to hour 168
State of Consciousness
Time frame: Up to hour 168
Renal Function
Time frame: Up to hour 168

Results and safety

Results posted to the registry on 15 Oct 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Ascorbic Acid	84	59
5% Dextrose in Water	83	44

Primary outcome: Modified Change in Sequential Organ Failure Assessment (mSOFA) Score

Time frame: 96 hours. Mean (Standard Deviation). Unit: score on a scale

Measure	Ascorbic Acid n = 84	5% Dextrose in Water n = 83
Value	-2.96 (4.20)	-3.20 (3.30)

Population analysed: 3 participants were omitted from the analysis because the etiology of the patients SEPSIS was not representative of the typical SEPSIS patient

Primary outcome: C-Reactive Protein at Study Hours 0, 48, 96, 168 When Compared to Placebo

Time frame: up to 168 hours. Mean (Standard Deviation). Unit: µg/ml

Measure	Ascorbic Acid n = 84	5% Dextrose in Water n = 83
0 hours	109 (76)	119 (67)
48 hours	80 (66)	84 (52)
96 hours	56 (51)	59 (52)
168 hours	54 (48)	46 (33)

Population analysed: 3 participants were omitted from the analysis because the etiology of the patients SEPSIS was not representative of the typical SEPSIS patient

Primary outcome: Thrombomodulin Protein at Study Hours 0, 48, 96, 168 When Compared to Placebo

Time frame: Up to 168 hours. Mean (Standard Deviation). Unit: ng/ml

Measure	Ascorbic Acid n = 84	5% Dextrose in Water n = 83
0 hours	14 (11)	14 (8)
48 hours	15 (11)	15 (10)
96 hours	15 (10)	15 (10)
168 hours	14 (9)	14 (9)

18 secondary outcomes are reported in the full results.

Adverse events

Time frame: All-cause mortality was collected for all days in the ICU, up to 4 days. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Ascorbic Acid	0 of 84 (0%)	0 of 84 (0%)	25 of 84
5% Dextrose in Water	0 of 83 (0%)	0 of 83 (0%)	38 of 83

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 31573637Fowler AA 3rd, Truwit JD, Hite RD, Morris PE, DeWilde C, Priday A, Fisher B, Thacker LR 2nd, Natarajan R, Brophy DF, Sculthorpe R, Nanchal R, Syed A, Sturgill J, Martin GS, Sevransky J, Kashiouris M, Hamman S, Egan KF, Hastings A, Spencer W, Tench S, Mehkri O, Bindas J, Duggal A, Graf J, Zellner S, Yanny L, McPolin C, Hollrith T, Kramer D, Ojielo C, Damm T, Cassity E, Wieliczko A, Halquist M. Effect of Vitamin C Infusion on Organ Failure and Biomarkers of Inflammation and Vascular Injury in Patients With Sepsis and Severe Acute Respiratory Failure: The CITRIS-ALI Randomized Clinical Trial. JAMA. 2019 Oct 1;322(13):1261-1270. doi: 10.1001/jama.2019.11825.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Alpha B. Fowler, MD principal investigator

Virginia Commonwealth University

5 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Ascorbic Acid in people with Acute Lung Injury and Sepsis, run by Virginia Commonwealth University at 5 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 18 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 15 Oct 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Modified Change in Sequential Organ Failure Assessment (mSOFA) Score (time frame: 96 hours). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02106975, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Oct 2019.