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SepsisPhase 3VICTASNCT03509350

Vitamin C, Thiamine, and Steroids in Sepsis

A Phase 3 study testing Vitamin C, Thiamine and Hydrocortisone in people with Sepsis, run by Emory University at 43 sites in United States.

Completed

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

Official record
Search all trials

Trial summary

The VItamin C, Thiamine And Steroids in Sepsis (VICTAS) Study is a double-blind, placebo-controlled, adaptive randomized clinical trial designed to investigate the efficacy of the combined use of vitamin C, thiamine and corticosteroids versus indistinguishable placebos for patients with sepsis. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Sepsis
What is being tested?
Vitamin C, Thiamine and Hydrocortisone
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
501 participants
Where
43 sitesUnited States
Study dates
22 Aug 2018to 29 Jan 2020
Phase
Phase 3
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

  • Suspected or confirmed infection as evidenced by ordering of blood cultures and administration of at least one antimicrobial agent
  • Anticipated or confirmed intensive care unit (ICU) admission
  • Acute respiratory or cardiovascular organ dysfunction attributed to sepsis as evidenced by at least one of the following requirements:
  • Vasopressor Requirement - Continuous infusion of norepinephrine, epinephrine, vasopressin, dopamine, phenylephrine or other vasopressor agents at any dose for greater than 1 hour and required to maintain a mean arterial pressure ≥ 65 mm Hg despite intravenous crystalloid infusion of at least 1000cc
  • Respiratory Support Requirement - Acute hypoxemic respiratory failure defined as persistent hypoxemia (partial pressure of arterial oxygen (PaO2)/fraction of inspired oxygen (FiO2) ≤ 300 or blood oxygen saturation (SpO2)/FiO2 ≤ 315) requiring (1) intubation and mechanical ventilation, or (2) positive pressure ventilation via tight-fitting face mask (i.e. continuous positive airway pressure (CPAP) or bilevel positive airway pressure (BiPAP) or (3) high flow nasal cannula ≥ 40 liter per minute (LPM) flow and FiO2 ≥ 0.40

Who cannot join

  • Weight < 40 kilograms (kg)
  • Prior enrollment in this study
  • Qualifying organ dysfunction no longer present at the time subject would be randomized
  • Cardiovascular or respiratory organ failure caused by an illness other than sepsis
  • First episode of qualifying organ dysfunction during the current emergency department (ED) or ICU admission occurred > 24 hours before the subject could be randomized
  • Limitations of care (defined as refusal of cardiovascular and respiratory support modes) including "do not intubate" (DNI) status
Show all 16Show fewer
  • Current hospitalization > 30 days at time of randomization
  • Chronic hypoxemia requiring supplemental non-invasive oxygen (nasal cannula or NIPPV) or home mechanical ventilation
  • Chronic cardiovascular failure requiring home mechanical hemodynamic support (e.g., LVAD) or home chemical hemodynamic support (e.g., milrinone)
  • Known allergy or contraindication to vitamin C, thiamine, and/or corticosteroids (including previously or currently diagnosed primary hyperoxaluria and/or oxalate nephropathy, or known/suspected ethylene glycol ingestion, or known glucose-6-phosphate dehydrogenase (G6PD) deficiency)
  • Use of vitamin C at a dose of > 1 gram daily within the 24 hours preceding first episode of qualifying organ dysfunction during a given ED or ICU admission
  • Chronic disease/illness that, in the opinion of the site investigator, have an expected lifespan of < 30 days unrelated to current sepsis diagnosis (e.g., stage IV malignancy, neurodegenerative disease, etc.)
  • Pregnancy or known active breastfeeding
  • Prisoner or Incarceration
  • Current participation in another interventional research study
  • Inability or unwillingness of subject or legal surrogate/representative to give written informed consent

Trial locations and contacts

43 sites in 1 country.

43 sites in 1 country

United States43 sites

  • University of Michigan

    Ann Arbor, Michigan, 48109

  • Piedmont Healthcare

    Atlanta, Georgia, 30078

  • Grady Memorial Hospital

    Atlanta, Georgia, 30303

  • Emory University Hospital

    Atlanta, Georgia, 30322

  • Emory Saint Joseph's Hospital

    Atlanta, Georgia, 30342

  • Johns Hopkins Bayview

    Baltimore, Maryland, 21224

  • Johns Hopkins Hospital

    Baltimore, Maryland, 21287

  • University of Maryland School of Medicine

    Baltimore, Maryland, 55415

  • Medical University of South Carolina

    Charleston, South Carolina, 19107

  • University of Cincinnati Physicians Company

    Cincinnati, Ohio, 23114

  • Cleveland Clinic

    Cleveland, Ohio, 44195

  • Ohio State University Wexner Medical Center

    Columbus, Ohio, 45241

  • University of Colorado Denver

    Denver, Colorado, 19140

  • Denver Health

    Denver, Colorado, 80204

  • Henry Ford Health System

    Detroit, Michigan, 27710

  • Duke University

    Durham, North Carolina, 90024

  • University of Florida Jacksonville

    Jacksonville, Florida, 32209

  • David Geffen School of Medicine at UCLA

    Los Angeles, California, 30322

  • Hennepin County Medical Center

    Minneapolis, Minnesota, 48202

  • Intermountain Medical Center

    Murray, Utah, 84157

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232

  • Yale New Haven Hospital

    New Haven, Connecticut, 94304

  • Lousiana State University

    New Orleans, Louisiana, 70112

  • Memorial Sloan Kettering Cancer Center

    New York, New York, 10065

  • Christiana Care

    Newark, Delaware, 19718

  • Sentara Healthcare

    Norfolk, Virginia, 23507

  • University of Nebraska Medical Center

    Omaha, Nebraska, 68198

  • University of Pennsylvania Health System Hospital

    Philadelphia, Pennsylvania, 19104

  • Thomas Jefferson University

    Philadelphia, Pennsylvania, 21224

  • Temple University

    Philadelphia, Pennsylvania, 29425

  • Maricopa Integrated Health System

    Phoenix, Arizona, 80045

  • Oregon Health Sciences University

    Portland, Oregon, 27157

  • Virginia Commonwealth University

    Richmond, Virginia, 23284

  • Bon Secours

    Richmond, Virginia, 85008

  • Mayo Clinic

    Rochester, Minnesota, 55902

  • University of Utah

    Salt Lake City, Utah, 37235

  • Baystate Health

    Springfield, Massachusetts, 01199

  • Stanford University

    Stanford, California, 21201

  • Montefiore Medical Center Weiler

    The Bronx, New York, 10461

  • Montefiore Medical Center Moses

    The Bronx, New York, 10467

  • University of Arizona

    Tucson, Arizona, 85724

  • Medstar Washington Hospital Center

    Washington D.C., District of Columbia, 20010

  • Wake Forest University

    Winston-Salem, North Carolina, 43210

Other trials in United States

About this study

Official title: A Multi-center, Randomized, Placebo-controlled, Double-blind, Adaptive Clinical Trial of Vitamin C, Thiamine and Steroids as Combination Therapy in Patients With Sepsis.

The VItamin C, Thiamine And Steroids in Sepsis (VICTAS) Study is a double-blind, placebo-controlled, adaptive randomized clinical trial designed to investigate the efficacy of the combined use of vitamin C, thiamine and corticosteroids versus indistinguishable placebos for patients with sepsis. The objective of this study is to demonstrate the efficacy of combination therapy using vitamin C, thiamine and corticosteroids in reducing mortality and improving organ function in critically ill patients with sepsis.

Read the detailed description

Sepsis is an inflammatory syndrome with life threatening organ dysfunction resulting from a dysregulated host response to infection. The global burden is estimated to exceed 15 million cases annually. In the United States, the incidence is increasing and currently there are more 1,750,000 cases each year, with more than half requiring intensive care unit (ICU) admission. Further, sepsis cases account for 30%- 50% of all hospital deaths, making it the 3rd leading cause of death in the United States, and is the most expensive reason for hospitalization with annual expenditures exceeding $20 billion. Notably, even among those that do survive, many endure significant reductions in physical, emotional and cognitive quality of life. New therapeutic approaches to reduce the high morbidity and mortality of sepsis are needed.

Current management strategies focus on early aggressive fluid resuscitation, blood pressure support with vasopressors, early appropriate antibiotics, and the identification and control of infected sites. Though outcomes have improved with the bundled deployment of these strategies, mortality remains high at 20 - 30%. Despite over a hundred phase 2 and phase 3 clinical trials of pharmacological agents with the potential to improve sepsis outcomes, only antibiotics have demonstrated reproducible benefits.

The purpose of the current study is therefore to determine (or confirm) the efficacy of the combination therapy consisting of vitamin C, thiamine, and corticosteroids in the management of patients with circulatory and/or respiratory dysfunction resulting from sepsis. This subset of sepsis patients has been chosen because they are easily identified, have a high mortality, and consume significant critical care resources. As such, any improvements in outcomes attributed to effective therapies would be of great value to patients, as well as their care providers and healthcare systems. Further, because the promulgated therapies are composed of three inexpensive and readily available drugs, its efficacy would have important implications the management of sepsis in both well and poorly resourced settings worldwide.

The VItamin C, Thiamine And Steroids in Sepsis (VICTAS) Study is a double-blind, placebo-controlled, adaptive randomized clinical trial designed to investigate the efficacy of the combined use of vitamin C, thiamine and corticosteroids (the Treatment Protocol) versus indistinguishable placebos (the Control Protocol) for patients with sepsis. The trial will enroll up to 2000 participant and employs a novel endpoint that approximates a patient's risk of death based on the time spent on vasopressors or receiving respiratory support. Time spent on vasopressors or receiving respiratory support captures a patient's speed of recovery. Mortality rate is a key secondary endpoint for the trial.

Specific Aims

  1. To demonstrate the efficacy of combination therapy using vitamin C, thiamine and corticosteroids to reduce the duration of cardiovascular and respiratory organ dysfunction in critically ill patients with sepsis.
  2. To demonstrate the efficacy of combination therapy using vitamin C, thiamine and corticosteroids to reduce 30-day mortality in critically ill patients with sepsis.

Explicit subject consent for participation in long term telephone follow-up will be sought for all patients at all sites. Participation in long term outcome assessments is not required for participation in other aspects of the VICTAS study, i.e., patients may individually opt out of this portion of the study. In these participants a diverse array of neurocognitive outcomes will be assessed approximately 6 months after patient discharge. Evaluations will be done using a specially-designed battery of tests that evaluates key aspects of functioning and behavior and will be administered via phone by the Vanderbilt Long-Term Outcomes team, which will serve as the coordinating center for these follow-up assessments. The battery, which takes about 40 minutes to complete, will assess cognition, mental health, quality of life, and employment - all of which have been shown to be adversely affected in between one third and two thirds of survivors of sepsis.

Conditions
Sepsis
Being tested
Vitamin C, Thiamine, Hydrocortisone, Vitamin C Placebo, Thiamine Placebo
Keywords
Vitamin C, Thiamine, Corticosteroid
Medical subject headings
Sepsis

What participants receive

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

  • Vitamin CDrug

    Also called Ascorbic acid

    Intravenous vitamin C (1.5 grams every 6 hours) will be administered for 4 days or until ICU discharge.

  • ThiamineDrug

    Also called Thiamine hydrochloride

    Intravenous thiamine (100 mg every 6 hours) will be administered for 4 days or until ICU discharge.

  • HydrocortisoneDrug

    Also called Hydrocortisone sodium succinate

    Intravenous hydrocortisone (50 mg every 6 hours) will be administered for 4 days or until ICU discharge.

  • Vitamin C PlaceboDrug

    Also called Placebo

    A placebo to match intravenous vitamin C (1.5 grams every 6 hours) will be administered for 4 days or until ICU discharge.

  • Thiamine PlaceboDrug

    Also called Placebo

    A placebo to match intravenous thiamine (100 mg every 6 hours) will be administered for 4 days or until ICU discharge.

  • Hydrocortisone PlaceboDrug

    Also called Placebo

    A placebo to match intravenous hydrocortisone (50 mg every 6 hours) will be administered for 4 days or until ICU discharge. Steroids will be used when clinically indicated.

Study groups in NCT03509350
Study groupRoleWhat they receive
Treatment ProtocolExperimentalParticipants randomized to the treatment protocol will receive the VICTAS Intervention, consisting of intravenous vitamin C, thiamine, and hydrocortisone for four days or until ICU discharge.
Receives: Drug: Vitamin C; Drug: Thiamine; Drug: Hydrocortisone
Control ProtocolPlacebo comparatorA placebo to match the VICTAS intervention will be administered for four days or until ICU discharge. During the treatment period, if an indication for steroids exist, the treating physicians are permitted to initiate open-label corticosteroid therapy based on local practice and international guidelines. If this occurs, the hydrocortisone/placebo will be withheld and subjects will be started on open-label corticosteroids.
Receives: Drug: Vitamin C Placebo; Drug: Thiamine Placebo; Drug: Hydrocortisone Placebo

What is being measured

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

  1. Vasopressor and Ventilator-free Days (VVFD)

    The primary outcome measure is VVFD in the first 30 days after the start of treatment. The endpoint was recorded to the nearest day. Participants who died are scored zero days, even if there was a period during which the participant was alive and free of vasopressors and mechanical ventilation. Participants who must return to ventilation and/or vasopressors had their counters reset at zero days.

    Measured: Up to Day 30

Secondary outcomes (18)

  1. Mortality at 30 Days

    The number of participants who did not survive until Day 30 is compared between study arms.

    Measured: Day 30

  2. Intensive Care Unit (ICU) Mortality

    The number of participants who died while in the ICU is compared between study arms.

    Measured: Day 30

  3. Mortality at 180 Days

    The number of participants who did not survive until Day 180 is compared between study arms.

    Measured: Day 180

  4. Length of ICU Stay

    The number of days that participants were in the ICU is compared between study arms.

    Measured: Day 30

  5. Length of Hospital Stay

    The number of days that participants were in the hospital is compared between study arms.

    Measured: Day 30

  6. Digit Span Test Score

    The Digit Span Test is used to assesses attention. In the Digit Span Test, participants are read a series of numbers and are asked to repeat them back in the same order. The Digit Span test is scored by the number of digits the participant is able to remember in each test. Higher scores indicate greater ability to pay attention and to remember sequences. The average adult can remember about 7 numbers, plus or minus two, without making an error.

    Measured: Day 180

  7. Number of Participants With Delirium Assessed With the DeliriumTelephone Confusion Assessment Method (CAM)

    The Telephone CAM evaluates dementia with 9-items, where additional questions are asked if symptoms are present. Rather than providing a summary score, if participants exhibit signs of a change in mental status which fluctuates and they experience inattention, along with disorganized thinking or altered level of consciousness, delirium is suggested.

    Measured: Day 180

  8. Hayling Test Score

    Executive function is assessed with the Hayling Test. The Hayling Test includes two parts of 15 items each where participants complete sentences by providing the missing word. The test is scored as the amount of time it takes, in seconds, to recite a correct response and the appropriateness of the response (in Part 2). Scaled scores range from 1 to 10 where 1 = impaired, 6 = average, and 10 = very superior.

    Measured: Day 180

  9. Controlled Oral Word Association Test (COWAT) Score

    Language is assessed with the Controlled Oral Word Association Test (COWAT). Participants generate words beginning with selected letters within 60 seconds. Generating a higher number of words indicates greater language skills.

    Measured: Day 180

  10. Wechsler Memory Scale III - Delayed Recall Logical Memory Score

    Memory is assessed with the Logical Memory subtest from the Wechsler Memory Scale III. Participants listened to two short paragraphs and were asked to recall details from each story after 30 minutes. Scores represent the number of correctly remembered details. Total scores range from 0 to 25 with higher scores reflecting better memory.

    Measured: Day 180

  11. Telephone Interview for Cognitive Status (TICS)

    The Telephone Interview for Cognitive Status (TICS) is an 11-item instrument assessing orientation. Correct responses to the items are scored in a variety of ways, depending on how much of the response is correct. Total scores range from 0 to 41 with higher scores indicating increased cognitive orientation.

    Measured: Day 180

  12. Wechsler Adult Intelligence Scale (WAIS)-IV Similarities Score

    Reasoning is assessed with the WAIS-IV Similarities instrument. Participants were asked to explain how two words are alike. Responses are scored according to how correct they are, with a score of 0 for incorrect answers. After 3 consecutive scores of 0 the survey is stopped. Total raw scores vary depending on the number of word pairs presented. Higher scores indicate better performance. Scores will be compared between study arms.

    Measured: Day 180

  13. Katz Index of Independence in Activities of Daily Living (ADL) Score

    Activities of daily living is assessed with the Katz ADL instrument. The Katz ADL has 6 items asking if participants can perform daily tasks independently. Responses are scored as 1 = yes and 0 = no. Total scores range from 0 to 6 with higher scores indicating greater independence.

    Measured: Day 180

  14. Number of Participants Employed

    The Employment Questionnaire is a brief measure of the participant's employment history and ability or capacity to work. The number of participants who indicated being employed are presented here.

    Measured: Day 180

  15. Functional Activities Questionnaire (FAQ) Score

    Instrumental activities of daily living is assessed with the Functional Activities Questionnaire (FAQ). The FAQ includes 10 items which are scored on a scale from 0 to 3 where 0 = normal and 3 = dependent. Total scores range from 0 to 30 and lower scores indicate that the respondent is able to perform daily activities. A score of 9 (where the person is dependent in 3 activities) is used as a cut-point indicating impairments with functioning.

    Measured: Day 180

  16. Patient-Reported Outcomes Measurement Information System (PROMIS) Depression 6

    Depression is assessed with the PROMIS Depression 6 instrument. This tool includes 6 items with response options on a scale of 1 to 5. Total raw scores range from 6 to 30 with higher scores indicating greater symptoms of depression.

    Measured: Day 180

  17. Posttraumatic Stress Disorder-8 (PTSD-8) Score

    Posttraumatic Stress Disorder (PTSD) is assessed with the Posttraumatic Stress Disorder - 8 instrument. The PTSD-8 includes 8 items which are answered on a 4 point scale where 01 = not at all and 3 = all of the time. Total scores range from 0 to 24 where higher scores indicate greater symptoms of PTSD.

    Measured: Day 180

  18. EuroQol, 5 Dimension (EQ-5D) Visual Analog Scale Score

    Quality of life is assessed with the Visual Analog Scale of the EuroQol, 5 dimension (EQ-5D) questionnaire. The EQ-5D asks about 5 dimensions of health (mobility, self-care, usual activities, pain, and depression). The questionnaire includes a visual analog scale where respondents rate their current health where 0 = worst health imaginable and 100 = best health imaginable.

    Measured: Day 180

Timeline

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

  1. First posted26 Apr 2018
  2. Study start22 Aug 2018
  3. Primary completion22 Aug 2019
  4. Study completion29 Jan 2020

Resources

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 3
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
501 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03509350
Sponsor's protocol ID
IRB00102528
Other IDs
IRB00164053
Acronym
VICTAS
Status last verified
Mar 2021
First submitted
10 Apr 2018
Last updated
13 Apr 2021
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Williams Roberson S, Nwosu S, Collar EM, Kiehl AL, Harrison FE, Bastarache J, Wilson JE, Mart MF, Sevransky JE, Ely EW, Lindsell CJ, Jackson JC; VICTAS Investigators. Association of Vitamin C, Thiamine, and Hydrocortisone Infusion With Long-term Cognitive, Psychological, and Functional Outcomes in Sepsis Survivors: A Secondary Analysis of the Vitamin C, Thiamine, and Steroids in Sepsis Randomized Clinical Trial. JAMA Netw Open. 2023 Feb 1;6(2):e230380. doi: 10.1001/jamanetworkopen.2023.0380.

    PubMed 36853612

  • Sevransky JE, Rothman RE, Hager DN, Bernard GR, Brown SM, Buchman TG, Busse LW, Coopersmith CM, DeWilde C, Ely EW, Eyzaguirre LM, Fowler AA, Gaieski DF, Gong MN, Hall A, Hinson JS, Hooper MH, Kelen GD, Khan A, Levine MA, Lewis RJ, Lindsell CJ, Marlin JS, McGlothlin A, Moore BL, Nugent KL, Nwosu S, Polito CC, Rice TW, Ricketts EP, Rudolph CC, Sanfilippo F, Viele K, Martin GS, Wright DW; VICTAS Investigators. Effect of Vitamin C, Thiamine, and Hydrocortisone on Ventilator- and Vasopressor-Free Days in Patients With Sepsis: The VICTAS Randomized Clinical Trial. JAMA. 2021 Feb 23;325(8):742-750. doi: 10.1001/jama.2020.24505.

    PubMed 33620405

  • Lindsell CJ, McGlothlin A, Nwosu S, Rice TW, Hall A, Bernard GR, Busse LW, Ely EW, Fowler AA, Gaieski DF, Hinson JS, Hooper MH, Jackson JC, Kelen GD, Levine M, Martin GS, Rothman RE, Sevransky JE, Viele K, Wright DW, Hager DN. In response: Letter on update to the Vitamin C, Thiamine and Steroids in Sepsis (VICTAS) protocol. Trials. 2020 Apr 22;21(1):351. doi: 10.1186/s13063-020-04290-6.

    PubMed 32317004

  • Morgan J. Surviving sepsis and intensive care unit delirium: a remarkable recovery. Lancet Respir Med. 2020 Mar;8(3):241-242. doi: 10.1016/S2213-2600(20)30043-6. Epub 2020 Jan 30. No abstract available.

    PubMed 32007132

  • Lindsell CJ, McGlothlin A, Nwosu S, Rice TW, Hall A, Bernard GR, Busse LW, Ely EW, Fowler AA, Gaieski DF, Hinson JS, Hooper MH, Jackson JC, Kelen GD, Levine M, Martin GS, Rothman RE, Sevransky JE, Viele K, Wright DW, Hager DN. Update to the Vitamin C, Thiamine and Steroids in Sepsis (VICTAS) protocol: statistical analysis plan for a prospective, multicenter, double-blind, adaptive sample size, randomized, placebo-controlled, clinical trial. Trials. 2019 Dec 4;20(1):670. doi: 10.1186/s13063-019-3775-8.

    PubMed 31801567

  • Hager DN, Hooper MH, Bernard GR, Busse LW, Ely EW, Fowler AA, Gaieski DF, Hall A, Hinson JS, Jackson JC, Kelen GD, Levine M, Lindsell CJ, Malone RE, McGlothlin A, Rothman RE, Viele K, Wright DW, Sevransky JE, Martin GS. The Vitamin C, Thiamine and Steroids in Sepsis (VICTAS) Protocol: a prospective, multi-center, double-blind, adaptive sample size, randomized, placebo-controlled, clinical trial. Trials. 2019 Apr 5;20(1):197. doi: 10.1186/s13063-019-3254-2.

    PubMed 30953543

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Vitamin C, Thiamine and Hydrocortisone in people with Sepsis, run by Emory University at 43 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 5 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 13 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 43 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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 18 Sep 2020). 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?

Vasopressor and Ventilator-free Days (VVFD) (time frame: Up to Day 30). 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 NCT03509350, which also lists 6 linked publications.

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 13 Apr 2021.

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