SepsisPhase 3NCT05192213

Vitamin C, Hydrocortisone and Thiamine in Patients With Septic Shock

A Phase 3 study testing Vitamin C in people with Sepsis and Septic Shock, run by Hospital Sirio-Libanes at 12 sites in Brazil.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 years and older
Conditions the study is for: Sepsis, Septic Shock
What is being tested?: Vitamin C
Type of treatment: Injection or infusion
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 71 participants
Where: 12 sitesBrazil
Study dates: 1 Aug 2021to 19 Sep 2022
Phase: Phase 3
Are there results?: None posted in the registry

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

Above 18 years of age
Sepsis of any background
Vasopressor-dependent sepsis for at least 2 hours and vasopressor dose ≥ 0.25 µg / kg / min

Who cannot join

Pregnancy;
Requests for DNR (do not resuscitate) / DNI (do not intubate);
Death is considered imminent or inevitable during this hospitalization and the attending physician, patient or substitute decision maker is not committed to active treatment;
Patients with acute cerebral vascular event, acute coronary syndrome, active gastrointestinal bleeding, burn or trauma at admission;
Patients with known HIV infection;
Patients with known glucose-6 phosphate dehydrogenase (G-6PD) deficiency;

Show all 20Show fewer

Patients with septic shock transferred from another ICU or hospital with characteristics of septic shock for> 12 hours;
Patients with septic shock characteristics for> 12 hours;
Patients with a known history of oxalate nephropathy;
Patients with short bowel syndrome or severe known fat malabsorption;
Patients with acute beriberi disease;
Patients with acute Wernicke's encephalopathy;
Patients with known malaria;
Patients with known or suspected scurvy;
Patients with known or suspected Addison's disease;
Patients with known Cushing's disease;
Physician expects to prescribe or the patient has previously used (less than 15 days) systemic glucocorticoids for an indication other than septic shock (not including nebulized or inhaled corticosteroids), including the use of glucocorticoids for COVID-19;
The patient is receiving treatment for systemic fungal infection or has documented Strongyloides infection at the time of randomization;
Patient with known chronic iron overload due to iron storage and other diseases;
Patient previously enrolled in this study.

Trial locations and contacts

12 sites in 1 country.

City, postcode or hospital

12 sites in 1 country

Brazil12 sites

Hospital Maternidade São Vicente de Paulo
Barbalha, Ceará
Hospital de Amor - Unidade Barretos
Barretos, São Paulo, 14784-400
Hospital Felício Rocho
Belo Horizonte, Minas Gerais
Hospital Otoclinica
Fortaleza, Ceará, 60135-100
Hospital Clínica São Roque
Ipiaú, Estado de Bahia
Hospital Universitário de Maringá
Maringá, Paraná, 87083-240
Santa Casa de Misericordia de Passos
Passos, Minas Gerais, 37904-020
Hospital Naval Marcílio Dias
Rio de Janeiro
Hospital SEPACO
São Paulo, São Paulo, 04102-900
Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo - HCFMUSP
São Paulo
Hospital São Paulo
São Paulo
Hospital Evangélico de Vila Velha
Vila Velha, Espírito Santo

Other trials in Brazil

About this study

Official title: Vitamin C, Hydrocortisone and Thiamine in Patients With Septic Shock: a Randomized Clinical Study (VITAMIN TRIAL)

A great interest exists regarding substances with an immunomodulatory effect for sepsis patients. Recent data have shown that intravenous vitamin C, together with corticosteroids and thiamine, could prevent progressive organ dysfunction and reduce vasopressor use in patients with severe sepsis and septic shock. Its effect on mortality, on the other hand, is yet to be demonstrated. The Vitamins study aims to conclusively determine, through its prospective, multicentre and double-blinded design including 1090 patients, wether Vitamin C, Thiamine and Hydrocortisone in combination can reduce mortality in patients with septic shock.

Read the detailed description

The global burden of sepsis is substantial with an estimated 15 to 19 million cases per year, most occurring in low-income countries. With recent advances in diagnosis and supportive treatment, the 28-day mortality from sepsis in high-income countries has decreased by about 25%; however, the mortality from septic shock still remains around 45%.

A large volume of experimental data has shown that both corticosteroids and intravenous vitamin C attenuate the release of pro-inflammatory mediators, reduce the endothelial lesion characteristic of sepsis (reducing endothelial permeability and improving microcirculatory flow), increase the release of endogenous catecholamines and improve vasopressor reaction. In animal models, these effects resulted in reduced organ damage and increased survival. However, its effect on critically ill humans is controvert. Results of a retrospective study brought that the early use of intravenous vitamin C, together with corticosteroids and thiamine, can prevent progressive organ dysfunction and can reduce mortality in patients with severe sepsis and septic shock.

For this reason, the investigators propose a randomized, controlled, multicentre (mcRCT), pragmatic and feasibility study to investigate whether Vitamin C (1.5g 6 / 6h), along with thiamine (200 mg, 12 / 12h) and hydrocortisone (50 mg 6 / 6h) for 7 days can reduce all-cause mortality within 28 days after randomization.

Conditions: Sepsis, Septic Shock
Being tested: Vitamin C, Placebo
Keywords: sepsis, septic shock, vitamin C, thiamine, ICU
Medical subject headings: Sepsis, Shock, Septic

What participants receive

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

Vitamin CDrug
Also called thiamine, hydrocortisone
Patients will be allocated in a 1: 1 ratio to the treatment group, receiving intravenous Vitamin C (1.5 g every 6 hours), Thiamine (200 mg every 12 hours) and Hydrocortisone (50 mg every 6 hours) for 7 days
PlaceboOther
Patients will receive 2 placebos (every 6 hours and every 12 hours) + Hydrocortisone (50 mg every 6 hours) for 7 days.

Study groups in NCT05192213
Study group	Role	What they receive
Intervention	Experimental	1,5 g of vitamin C every 6 hours + 200 mg of thiamine every 12 hours + 50 mg of hydrocortisone every 6 hours For 7 days or until patient's discharge/death Receives: Drug: Vitamin C
Control	Placebo comparator	Placebo 1 for vitamin C every 6 hours + Placebo 2 for thiamine every 12 hours + 50 mg of hydrocortisone every 6 hours For 7 days or until patient's discharge/death Receives: Other: Placebo

What is being measured

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

28-day Mortality
Mortality by all causes at 28 days after randomization
Measured: 28 days

Secondary outcomes (4)

90-day Mortality
Mortality by all causes at 90 days after randomization
Measured: 90 days
Duration of support
Duration of use of vasoactive drugs, mechanical ventilation and renal replacement therapy
Measured: 28 days
Delta SOFA
Change in total Sequential Organ Failure Assessment (SOFA) score, comparing SOFA score at 72 hours and SOFA score at randomisation. Range 0-24. Lower SOFA scores represent better outcome.
Measured: 72 hours
Quality of life assessment
Difference in quality of life assessment using the EQ-5D questionnaire, from EuroQol Group. The questionnaire will be applied during intensive care unit (ICU) stay and after 6 months. Range 0-1, with 0 and 1 corresponding to death and full health, respectively. This will be applied in 30% of research sample.
Measured: 6 months

Timeline

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

1 Aug 202119 Sep 2022

First posted14 Jan 2022
Study start1 Aug 2021
Primary completion14 Jul 2022
Study completion19 Sep 2022

Why it stopped: In order to preserve the safety of the patients and prevent any harm from occurring, we opted to discontinue the study based on previous results (LOVIT study) published at 2022. Were recruited 71 than 1090 participants.

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (14)Papers the sponsor has linked to this study.
Other trials for SepsisStudies of the same condition, open and under way.
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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Quadruple blind
Who is masked: Participant, Care provider, Investigator, Outcomes assessor
Enrolment: 71 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT05192213
Sponsor's protocol ID: AVAP-NG 1000
Other IDs: 07445119.9.1001.5461
Status last verified: Jan 2024
First submitted: 7 Jun 2021
Last updated: 30 Jan 2024
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: The study protocol and SAP are not submitted.

Publications

Rhodes A, Evans LE, Alhazzani W, Levy MM, Antonelli M, Ferrer R, Kumar A, Sevransky JE, Sprung CL, Nunnally ME, Rochwerg B, Rubenfeld GD, Angus DC, Annane D, Beale RJ, Bellinghan GJ, Bernard GR, Chiche JD, Coopersmith C, De Backer DP, French CJ, Fujishima S, Gerlach H, Hidalgo JL, Hollenberg SM, Jones AE, Karnad DR, Kleinpell RM, Koh Y, Lisboa TC, Machado FR, Marini JJ, Marshall JC, Mazuski JE, McIntyre LA, McLean AS, Mehta S, Moreno RP, Myburgh J, Navalesi P, Nishida O, Osborn TM, Perner A, Plunkett CM, Ranieri M, Schorr CA, Seckel MA, Seymour CW, Shieh L, Shukri KA, Simpson SQ, Singer M, Thompson BT, Townsend SR, Van der Poll T, Vincent JL, Wiersinga WJ, Zimmerman JL, Dellinger RP. Surviving Sepsis Campaign: International Guidelines for Management of Sepsis and Septic Shock: 2016. Crit Care Med. 2017 Mar;45(3):486-552. doi: 10.1097/CCM.0000000000002255.
PubMed 28098591
Singer M, Deutschman CS, Seymour CW, Shankar-Hari M, Annane D, Bauer M, Bellomo R, Bernard GR, Chiche JD, Coopersmith CM, Hotchkiss RS, Levy MM, Marshall JC, Martin GS, Opal SM, Rubenfeld GD, van der Poll T, Vincent JL, Angus DC. The Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3). JAMA. 2016 Feb 23;315(8):801-10. doi: 10.1001/jama.2016.0287.
PubMed 26903338
Vincent JL, De Backer D. Circulatory shock. N Engl J Med. 2013 Oct 31;369(18):1726-34. doi: 10.1056/NEJMra1208943. No abstract available.
PubMed 24171518
Vincent JL, Pereira AJ, Gleeson J, Backer D. Early management of sepsis. Clin Exp Emerg Med. 2014 Sep 30;1(1):3-7. doi: 10.15441/ceem.14.005. eCollection 2014 Sep.
PubMed 27752546
Marik PE, Khangoora V, Rivera R, Hooper MH, Catravas J. Hydrocortisone, Vitamin C, and Thiamine for the Treatment of Severe Sepsis and Septic Shock: A Retrospective Before-After Study. Chest. 2017 Jun;151(6):1229-1238. doi: 10.1016/j.chest.2016.11.036. Epub 2016 Dec 6.
PubMed 27940189
Fujita I, Hirano J, Itoh N, Nakanishi T, Tanaka K. Dexamethasone induces sodium-dependant vitamin C transporter in a mouse osteoblastic cell line MC3T3-E1. Br J Nutr. 2001 Aug;86(2):145-9. doi: 10.1079/bjn2001406.
PubMed 11502226
Marik PE. Critical illness-related corticosteroid insufficiency. Chest. 2009 Jan;135(1):181-193. doi: 10.1378/chest.08-1149.
PubMed 19136406
he10 leading causes of death by country income group 2012. WHO factsheets. [http://www.who.int/mediacentre/factsheets/fs310/en/index1.html ]
Sales Junior JA, David CM, Hatum R, Souza PC, Japiassu A, Pinheiro CT, Friedman G, Silva OB, Dias MD, Koterba E, Dias FS, Piras C, Luiz RR; Grupo de Estudo de Sepse do Fundo AMIB. [An epidemiological study of sepsis in Intensive Care Units: Sepsis Brazil study]. Rev Bras Ter Intensiva. 2006 Mar;18(1):9-17. Portuguese.
PubMed 25310321
Zabet MH, Mohammadi M, Ramezani M, Khalili H. Effect of high-dose Ascorbic acid on vasopressor's requirement in septic shock. J Res Pharm Pract. 2016 Apr-Jun;5(2):94-100. doi: 10.4103/2279-042X.179569.
PubMed 27162802
Minneci PC, Deans KJ, Eichacker PQ, Natanson C. The effects of steroids during sepsis depend on dose and severity of illness: an updated meta-analysis. Clin Microbiol Infect. 2009 Apr;15(4):308-18. doi: 10.1111/j.1469-0691.2009.02752.x.
PubMed 19416302
Fujii T, Luethi N, Young PJ, Frei DR, Eastwood GM, French CJ, Deane AM, Shehabi Y, Hajjar LA, Oliveira G, Udy AA, Orford N, Edney SJ, Hunt AL, Judd HL, Bitker L, Cioccari L, Naorungroj T, Yanase F, Bates S, McGain F, Hudson EP, Al-Bassam W, Dwivedi DB, Peppin C, McCracken P, Orosz J, Bailey M, Bellomo R; VITAMINS Trial Investigators. Effect of Vitamin C, Hydrocortisone, and Thiamine vs Hydrocortisone Alone on Time Alive and Free of Vasopressor Support Among Patients With Septic Shock: The VITAMINS Randomized Clinical Trial. JAMA. 2020 Feb 4;323(5):423-431. doi: 10.1001/jama.2019.22176.
PubMed 31950979
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
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

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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Study at a glance

From the registry record, last updated by the sponsor on 30 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Vitamin C, Hydrocortisone and Thiamine in Patients With Septic Shock: a Randomized Clinical Study (VITAMIN TRIAL)
ClinicalTrials.gov ID: NCT05192213
Acronym / sponsor ID: AVAP-NG 1000
Conditions: Sepsis, Septic Shock
Keywords: sepsis, septic shock, vitamin C, thiamine, ICU
Phase: Phase 3
Study type: Interventional
Recruitment status: TerminatedReason stopped: In order to preserve the safety of the patients and prevent any harm from occurring, we opted to discontinue the study based on previous results (LOVIT study) published at 2022. Were recruited 71 than 1090 participants.
Enrolment: 71 participants (actual)
Lead sponsor: Hospital Sirio-LibanesUniversity, hospital or other
Collaborators: PROADI-SUS, Ministry of Health, Brazil
Study start: 1 Aug 2021 (actual)
Primary completion: 14 Jul 2022 (actual)
Study completion: 19 Sep 2022 (actual)
First posted: 14 Jan 2022 (actual)
Results: Not posted in the source record

Clinical summary

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

Detailed description

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
Intervention	Experimental	Drug: Vitamin C1,5 g of vitamin C every 6 hours + 200 mg of thiamine every 12 hours + 50 mg of hydrocortisone every 6 hours For 7 days or until patient's discharge/death
Control	Placebo comparator	Other: PlaceboPlacebo 1 for vitamin C every 6 hours + Placebo 2 for thiamine every 12 hours + 50 mg of hydrocortisone every 6 hours For 7 days or until patient's discharge/death

Who may qualify

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

Key inclusion criteria (3 listed)

Above 18 years of age
Sepsis of any background
Vasopressor-dependent sepsis for at least 2 hours and vasopressor dose ≥ 0.25 µg / kg / min

Key exclusion criteria (20 listed)

Pregnancy;
Requests for DNR (do not resuscitate) / DNI (do not intubate);
Death is considered imminent or inevitable during this hospitalization and the attending physician, patient or substitute decision maker is not committed to active treatment;
Patients with acute cerebral vascular event, acute coronary syndrome, active gastrointestinal bleeding, burn or trauma at admission;
Patients with known HIV infection;

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
Vitamin CAlso: thiamine, hydrocortisonePatients will be allocated in a 1: 1 ratio to the treatment group, receiving intravenous Vitamin C (1.5 g every 6 hours), Thiamine (200 mg every 12 hours) and Hydrocortisone (50 mg every 6 hours) for 7 days	Drug	Intervention
PlaceboPatients will receive 2 placebos (every 6 hours and every 12 hours) + Hydrocortisone (50 mg every 6 hours) for 7 days.	Other	Control

Primary outcome

28-day Mortality
Time frame: 28 days
Mortality by all causes at 28 days after randomization

4 secondary outcomes

90-day Mortality
Time frame: 90 days
Duration of support
Time frame: 28 days
Delta SOFA
Time frame: 72 hours
Quality of life assessment
Time frame: 6 months

Results and safety

The study was stopped early (reason given: In order to preserve the safety of the patients and prevent any harm from occurring, we opted to discontinue the study based on previous results (LOVIT study) published at 2022. Were recruited 71 than 1090 participants.). Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2024.
Background: PubMed 28098591Rhodes A, Evans LE, Alhazzani W, Levy MM, Antonelli M, Ferrer R, Kumar A, Sevransky JE, Sprung CL, Nunnally ME, Rochwerg B, Rubenfeld GD, Angus DC, Annane D, Beale RJ, Bellinghan GJ, Bernard GR, Chiche JD, Coopersmith C, De Backer DP, French CJ, Fujishima S, Gerlach H, Hidalgo JL, Hollenberg SM, Jones AE, Karnad DR, Kleinpell RM, Koh Y, Lisboa TC, Machado FR, Marini JJ, Marshall JC, Mazuski JE, McIntyre LA, McLean AS, Mehta S, Moreno RP, Myburgh J, Navalesi P, Nishida O, Osborn TM, Perner A, Plunkett CM, Ranieri M, Schorr CA, Seckel MA, Seymour CW, Shieh L, Shukri KA, Simpson SQ, Singer M, Thompson BT, Townsend SR, Van der Poll T, Vincent JL, Wiersinga WJ, Zimmerman JL, Dellinger RP. Surviving Sepsis Campaign: International Guidelines for Management of Sepsis and Septic Shock: 2016. Crit Care Med. 2017 Mar;45(3):486-552. doi: 10.1097/CCM.0000000000002255.
Background: PubMed 26903338Singer M, Deutschman CS, Seymour CW, Shankar-Hari M, Annane D, Bauer M, Bellomo R, Bernard GR, Chiche JD, Coopersmith CM, Hotchkiss RS, Levy MM, Marshall JC, Martin GS, Opal SM, Rubenfeld GD, van der Poll T, Vincent JL, Angus DC. The Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3). JAMA. 2016 Feb 23;315(8):801-10. doi: 10.1001/jama.2016.0287.
Background: PubMed 24171518Vincent JL, De Backer D. Circulatory shock. N Engl J Med. 2013 Oct 31;369(18):1726-34. doi: 10.1056/NEJMra1208943. No abstract available.
Background: PubMed 27752546Vincent JL, Pereira AJ, Gleeson J, Backer D. Early management of sepsis. Clin Exp Emerg Med. 2014 Sep 30;1(1):3-7. doi: 10.15441/ceem.14.005. eCollection 2014 Sep.
Background: PubMed 27940189Marik PE, Khangoora V, Rivera R, Hooper MH, Catravas J. Hydrocortisone, Vitamin C, and Thiamine for the Treatment of Severe Sepsis and Septic Shock: A Retrospective Before-After Study. Chest. 2017 Jun;151(6):1229-1238. doi: 10.1016/j.chest.2016.11.036. Epub 2016 Dec 6.
Background: PubMed 11502226Fujita I, Hirano J, Itoh N, Nakanishi T, Tanaka K. Dexamethasone induces sodium-dependant vitamin C transporter in a mouse osteoblastic cell line MC3T3-E1. Br J Nutr. 2001 Aug;86(2):145-9. doi: 10.1079/bjn2001406.
Background: PubMed 19136406Marik PE. Critical illness-related corticosteroid insufficiency. Chest. 2009 Jan;135(1):181-193. doi: 10.1378/chest.08-1149.
Backgroundhe10 leading causes of death by country income group 2012. WHO factsheets. [http://www.who.int/mediacentre/factsheets/fs310/en/index1.html ]
Background: PubMed 25310321Sales Junior JA, David CM, Hatum R, Souza PC, Japiassu A, Pinheiro CT, Friedman G, Silva OB, Dias MD, Koterba E, Dias FS, Piras C, Luiz RR; Grupo de Estudo de Sepse do Fundo AMIB. [An epidemiological study of sepsis in Intensive Care Units: Sepsis Brazil study]. Rev Bras Ter Intensiva. 2006 Mar;18(1):9-17. Portuguese.
Background: PubMed 27162802Zabet MH, Mohammadi M, Ramezani M, Khalili H. Effect of high-dose Ascorbic acid on vasopressor's requirement in septic shock. J Res Pharm Pract. 2016 Apr-Jun;5(2):94-100. doi: 10.4103/2279-042X.179569.
Background: PubMed 19416302Minneci PC, Deans KJ, Eichacker PQ, Natanson C. The effects of steroids during sepsis depend on dose and severity of illness: an updated meta-analysis. Clin Microbiol Infect. 2009 Apr;15(4):308-18. doi: 10.1111/j.1469-0691.2009.02752.x.
Background: PubMed 31950979Fujii T, Luethi N, Young PJ, Frei DR, Eastwood GM, French CJ, Deane AM, Shehabi Y, Hajjar LA, Oliveira G, Udy AA, Orford N, Edney SJ, Hunt AL, Judd HL, Bitker L, Cioccari L, Naorungroj T, Yanase F, Bates S, McGain F, Hudson EP, Al-Bassam W, Dwivedi DB, Peppin C, McCracken P, Orosz J, Bailey M, Bellomo R; VITAMINS Trial Investigators. Effect of Vitamin C, Hydrocortisone, and Thiamine vs Hydrocortisone Alone on Time Alive and Free of Vasopressor Support Among Patients With Septic Shock: The VITAMINS Randomized Clinical Trial. JAMA. 2020 Feb 4;323(5):423-431. doi: 10.1001/jama.2019.22176.
Individual participant dataSharing planned: No. The study protocol and SAP are not submitted.

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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.

Luciano CP Azevedo, PhD principal investigator

Hospital Sirio-Libanês

Gisele Queiroz, MD principal investigator

Hospitla Sirio-Libanês

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

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Vitamin C in people with Sepsis and Septic Shock, run by Hospital Sirio-Libanes at 12 sites in Brazil.

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 3 inclusion and 20 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: stopped early, as of the sponsor's last update on 30 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in Brazil. 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?

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?

28-day Mortality (time frame: 28 days). 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 NCT05192213, which also lists 14 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 30 Jan 2024.