Septic ShockPhase 3NCT03872011
Vitamin C, Thiamine and Hydrocortisone for the Treatment of Septic Shock
A Phase 3 study testing Vitamin C,thiamine,hydrocortisone in people with Septic Shock, run by Northern Jiangsu People's Hospital at 1 site in China.
Trial summary
The purpose of this study is to determine whether the combination therapy (vitamin C,thiamine and hydrocortisone) is effective in the treatment of septic shock. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Septic Shock
- What is being tested?
- Vitamin C,thiamine,hydrocortisone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 408 participants
- Where
- 1 siteChina
- Study dates
- 19 Feb 2019to 20 Sep 2021
- 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
- Age 18 years old or older
- Onset of septic shock within 12 hours
Who cannot join
- Systemic corticosteroid therapy within the last 3 months before septic shock
- High-dose steroid therapy
- Immunosuppression
- Pregnant
- Known glucose-6 phosphate dehydrogenase (G-6PD) deficiency
- Known hemachromatosis
Show all 9Show fewer
- Known allergy to vitamin C, hydrocortisone, or thiamine
- Anticipated death from a preexisting disease within 90 days after randomization (as determined by the enrolling physician)
- Refusal of the attending staff or patient family
Trial locations and contacts
1 site in 1 country.
China1 site
Northern Jiangsu Province people's hospital
Yangzhou, Jiangsu, 225000
About this study
Official title: Initiation of Vitamin C, Thiamine and Hydrocortisone Therapy for Septic Shock in Adults: A Randomized Clinical Trial
The purpose of this study is to determine whether the combination therapy (vitamin C,thiamine and hydrocortisone) is effective in the treatment of septic shock.
Read the detailed description
Septic Shock is a leading cause of morbidity and mortality in critically ill patients worldwide.
A potential benefit of vitamin C with thiamine and low-dose hydrocortisone in the treatment of septic shock has recently been described(PMID 27940189) . The patients with septic shock who received this combination of medications weaned off pressors earlier, suffered less organ failure, and had improved mortality. The doses of vitamin C used in this trial are high, yet seemed to be safe and can be considered for use.
In this randomized controlled trial, we aim to evaluate the effect of the combination therapy (vitamin C,thiamine and hydrocortisone) on septic shock.
- Conditions
- Septic Shock
- Being tested
- Vitamin C,thiamine,hydrocortisone, Placebo
- Keywords
- septic shock, vitamin C, thiamine, hydrocortisone, mortality
- Medical subject headings
- Shock, Septic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vitamin C,thiamine,hydrocortisoneDrug
Also called Ascorbic Acid, Vitamin B1
Vitamin C (2g) will be diluted in 100ml 0.9%NACL and administered ivd every 6 hours for 5 days or until participant is discharged from the ICU.
Thiamine(200mg) will be diluted in 100ml 0.9%NACL and administered ivd every 12 hours for 5 days or until participant is discharged from the ICU. Hydrocortisone was administered 200 mg/d as a continuous infusion for 5 days or until participant is discharged from the ICU.
PlaceboDrug
Also called Normal saline
Normal saline (0.9% NaCl solution) volume to match all components
| Study group | Role | What they receive |
|---|---|---|
| Vitamin C,thiamine,hydrocortisone | Experimental | The combination of vitamin C, thiamine, hydrocortisone :
Vitamin C 2g every 6 hours x 5-days Thiamine 200mg every 12 hours x 5-days Hydrocortisone 200mg as a continuous infusion x 5-days Receives: Drug: Vitamin C,thiamine,hydrocortisone |
| Placebo | Placebo comparator | Normal Saline Solution (0.9%NaCl) in a volume to match all experimental arm components Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
90-day mortality
Death from any cause at 90 days after the onset of septic shock
Measured: 90 days after randomization
Secondary outcomes (3)
ICU mortality
All-cause mortality at ICU discharge
Measured: 90 days after randomization
Hospital mortality
All-cause mortality at hospital discharge
Measured: 90 days after randomization
28-day mortality
Death from any cause at 28 days after the onset of septic shock
Measured: 28 days after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2019
- Study start19 Feb 2019
- Primary completion20 Sep 2021
- Study completion20 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Septic ShockStudies 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
- 408 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northern Jiangsu People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Qing-quan Lv, Northern Jiangsu People's Hospital
- Investigators
- Qingquan Lyu, Master, Principal investigator, Northern Jiangsu People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03872011
- Sponsor's protocol ID
- 2019KY-145
- Status last verified
- Sep 2021
- First submitted
- 4 Mar 2019
- Last updated
- 23 Sep 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lyu QQ, Zheng RQ, Chen QH, Yu JQ, Shao J, Gu XH. Early administration of hydrocortisone, vitamin C, and thiamine in adult patients with septic shock: a randomized controlled clinical trial. Crit Care. 2022 Sep 28;26(1):295. doi: 10.1186/s13054-022-04175-x.
PubMed 36171582
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Initiation of Vitamin C, Thiamine and Hydrocortisone Therapy for Septic Shock in Adults: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03872011
- Acronym / sponsor ID
- 2019KY-145
- Conditions
- Septic Shock
- Keywords
- septic shock, vitamin C, thiamine, hydrocortisone, mortality
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 408 participants (actual)
- Lead sponsor
- Northern Jiangsu People's HospitalUniversity, hospital or other
- Study start
- 19 Feb 2019 (actual)
- Primary completion
- 20 Sep 2021 (actual)
- Study completion
- 20 Sep 2021 (actual)
- First posted
- 12 Mar 2019 (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.
The purpose of this study is to determine whether the combination therapy (vitamin C,thiamine and hydrocortisone) is effective in the treatment of septic shock.
Detailed description
Septic Shock is a leading cause of morbidity and mortality in critically ill patients worldwide.
A potential benefit of vitamin C with thiamine and low-dose hydrocortisone in the treatment of septic shock has recently been described(PMID 27940189) . The patients with septic shock who received this combination of medications weaned off pressors earlier, suffered less organ failure, and had improved mortality. The doses of vitamin C used in this trial are high, yet seemed to be safe and can be considered for use.
In this randomized controlled trial, we aim to evaluate the effect of the combination therapy (vitamin C,thiamine and hydrocortisone) on septic shock.
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 |
|---|---|---|
| Vitamin C,thiamine,hydrocortisone | Experimental | Drug: Vitamin C,thiamine,hydrocortisoneThe combination of vitamin C, thiamine, hydrocortisone : Vitamin C 2g every 6 hours x 5-days Thiamine 200mg every 12 hours x 5-days Hydrocortisone 200mg as a continuous infusion x 5-days |
| Placebo | Placebo comparator | Drug: PlaceboNormal Saline Solution (0.9%NaCl) in a volume to match all experimental arm components |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age 18 years old or older
- Onset of septic shock within 12 hours
Key exclusion criteria (9 listed)
- Systemic corticosteroid therapy within the last 3 months before septic shock
- High-dose steroid therapy
- Immunosuppression
- Pregnant
- Known glucose-6 phosphate dehydrogenase (G-6PD) deficiency
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 C,thiamine,hydrocortisoneAlso: Ascorbic Acid, Vitamin B1Vitamin C (2g) will be diluted in 100ml 0.9%NACL and administered ivd every 6 hours for 5 days or until participant is discharged from the ICU. Thiamine(200mg) will be diluted in 100ml 0.9%NACL and administered ivd every 12 hours for 5 days or until participant is discharged from the ICU. Hydrocortisone was administered 200 mg/d as a continuous infusion for 5 days or until participant is discharged from the ICU. | Drug | Vitamin C,thiamine,hydrocortisone |
| PlaceboAlso: Normal salineNormal saline (0.9% NaCl solution) volume to match all components | Drug | Placebo |
Primary outcome
90-day mortality
Time frame: 90 days after randomization
Death from any cause at 90 days after the onset of septic shock
3 secondary outcomes
ICU mortality
Time frame: 90 days after randomization
Hospital mortality
Time frame: 90 days after randomization
28-day mortality
Time frame: 28 days after randomization
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2021.
- Derived from this study: PubMed 36171582Lyu QQ, Zheng RQ, Chen QH, Yu JQ, Shao J, Gu XH. Early administration of hydrocortisone, vitamin C, and thiamine in adult patients with septic shock: a randomized controlled clinical trial. Crit Care. 2022 Sep 28;26(1):295. doi: 10.1186/s13054-022-04175-x.
- Individual participant dataSharing planned: No
Related trials for Septic Shock
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Sepsis
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.
Qingquan Lyu, Master principal investigator
Northern Jiangsu People's Hospital
1 site 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,thiamine,hydrocortisone in people with Septic Shock, run by Northern Jiangsu People's Hospital at 1 site in China.
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 2 inclusion and 9 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 23 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
90-day mortality (time frame: 90 days after randomization). 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 NCT03872011, 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 23 Sep 2021.