SepsisPhase 2NCT03592277
Vitamin C & Thiamine to Treat Sepsis and Septic Shock
A Phase 2 study testing Vitamin C and Vitamin B1 in people with Sepsis and Septic Shock, run by Trinity Health Of New England at 1 site in United States.
Trial summary
Investigators propose to investigate the use of IV vitamins B1 and C in a randomized, double-blinded, prospective trial to determine if these medications decrease mortality rates in patients with severe sepsis or septic shock. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Sepsis, Septic Shock
- What is being tested?
- Vitamin C and Vitamin B1
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Sep 2018to 22 Feb 2021
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Not diagnosed with severe sepsis or septic shock
- Younger than 18 or older than 90 years old
- With a history of nephrolithiasis
- Who are pregnant
- Weigh less than 30 kg
- Not located in the ICU
- Do not resuscitate (DNR) or do not intubate (DNI), no escalation of care, or comfort measures only (CMO)
- Currently on dialysis
Trial locations and contacts
1 site in 1 country.
United States1 site
Saint Francis Hospital and Medical Center
Hartford, Connecticut, 06105
About this study
Official title: Vitamins B1 and C to Improve Outcomes in Patients With Severe Sepsis
Investigators propose to investigate the use of IV vitamins B1 and C in a randomized, double-blinded, prospective trial to determine if these medications decrease mortality rates in patients with severe sepsis or septic shock.
Read the detailed description
Investigators propose to investigate the use of IV vitamins B1 and C in a randomized, double-blinded, prospective trial to determine if these medications decrease mortality rates in patients with severe sepsis or septic shock. Patients experiencing evidence-based diagnoses of sepsis and severe sepsis and septic shock will be randomized to the two study arms for care, and all other care left to decisions of intensive care teams.
- Conditions
- Sepsis, Septic Shock
- Being tested
- Vitamin C, Vitamin B1
- Keywords
- Sepsis, Septic Shock, Vitamin C, Thiamine
- 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 Ascorbic Acid
Patients will receive 1.5g of vitamin C in 100mL of 0.9% sodium chloride (normal saline) every six hours for four days or until discharge from the ICU, whichever happens first (seventeen dose maximum).
Vitamin B1Drug
Also called Thiamine
Patients will also receive 200 mg of IV vitamin B1 every 12 hours in 50 mL of normal saline for four days or until ICU discharge (whichever happens first, nine dose maximum).
| Study group | Role | What they receive |
|---|---|---|
| TREATMENT with Vitamins C and B1 | Experimental | Patients in the Vitamins C and B1 arm will receive 1.5g of vitamin C in 100mL of 0.9% sodium chloride (normal saline) every six hours for four days or until discharge from the ICU, whichever happens first (seventeen dose maximum). In addition, they will receive 200 mg IV vitamin B1 every 12 hours in 50 mL of normal saline for four days or until ICU discharge (whichever happens first, nine dose maximum). Receives: Drug: Vitamin C; Drug: Vitamin B1 |
| PLACEBO with saline only | No intervention | Patients in the placebo (control group) arm will receive the 100 mL of 0.9% sodium chloride every six hours and 50 mL of 0.9% sodium chloride every 12 hours to act as placebos for the vitamins C and B1 respectively. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality Rates
All-cause mortality from time of enrollment/treatment to 30 days post hospital discharge (up to 87 days)
Measured: From time of treatment to 30 days post hospital discharge, up to 87 days.
Secondary outcomes (5)
Hospital Length of Stay
Total number of days patient is admitted to the hospital
Measured: From admission to the hospital through hospital discharge, up to 57 days.
Intensive Care Unit Length of Stay
Total number of days patient is admitted to the ICU
Measured: From time of admission to the ICU through discharge from the ICU, up to 25 days
Readmission Rate
Readmission to the hospital within 30 days after discharge
Measured: 30 days after hospital discharge
Ventilator Days
Number of days patient required ventilator
Measured: From admission to the ICU through discharge from the ICU, up to 25 days.
Hours on Vasopressors
Number of hours patient required vasopressors in norepinephrine equivalence.
Measured: From admission to the ICU through discharge from the ICU, up to 25 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Jul 2018
- Study start14 Sep 2018
- Primary completion22 Feb 2021
- Study completion22 Feb 2021
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.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Trinity Health Of New England
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David Shapiro, MD, Principal investigator, Saint Francis Hospital and Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03592277
- Sponsor's protocol ID
- SF-18-42
- Status last verified
- Sep 2022
- First submitted
- 18 Jun 2018
- Last updated
- 28 Sep 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vitamins B1 and C to Improve Outcomes in Patients With Severe Sepsis
- ClinicalTrials.gov ID
- NCT03592277
- Acronym / sponsor ID
- SF-18-42
- Conditions
- Sepsis, Septic Shock
- Keywords
- Sepsis, Septic Shock, Vitamin C, Thiamine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Trinity Health Of New EnglandUniversity, hospital or other
- Study start
- 14 Sep 2018 (actual)
- Primary completion
- 22 Feb 2021 (actual)
- Study completion
- 22 Feb 2021 (actual)
- First posted
- 19 Jul 2018 (actual)
- Results
- Posted 28 Sep 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Investigators propose to investigate the use of IV vitamins B1 and C in a randomized, double-blinded, prospective trial to determine if these medications decrease mortality rates in patients with severe sepsis or septic shock.
Detailed description
Investigators propose to investigate the use of IV vitamins B1 and C in a randomized, double-blinded, prospective trial to determine if these medications decrease mortality rates in patients with severe sepsis or septic shock. Patients experiencing evidence-based diagnoses of sepsis and severe sepsis and septic shock will be randomized to the two study arms for care, and all other care left to decisions of intensive care teams.
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 |
|---|---|---|
| TREATMENT with Vitamins C and B1 | Experimental | Drug: Vitamin C, Drug: Vitamin B1Patients in the Vitamins C and B1 arm will receive 1.5g of vitamin C in 100mL of 0.9% sodium chloride (normal saline) every six hours for four days or until discharge from the ICU, whichever happens first (seventeen dose maximum). In addition, they will receive 200 mg IV vitamin B1 every 12 hours in 50 mL of normal saline for four days or until ICU discharge (whichever happens first, nine dose maximum). |
| PLACEBO with saline only | No intervention | –Patients in the placebo (control group) arm will receive the 100 mL of 0.9% sodium chloride every six hours and 50 mL of 0.9% sodium chloride every 12 hours to act as placebos for the vitamins C and B1 respectively. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (8 listed)
- Not diagnosed with severe sepsis or septic shock
- Younger than 18 or older than 90 years old
- With a history of nephrolithiasis
- Who are pregnant
- Weigh less than 30 kg
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: Ascorbic AcidPatients will receive 1.5g of vitamin C in 100mL of 0.9% sodium chloride (normal saline) every six hours for four days or until discharge from the ICU, whichever happens first (seventeen dose maximum). | Drug | TREATMENT with Vitamins C and B1 |
| Vitamin B1Also: ThiaminePatients will also receive 200 mg of IV vitamin B1 every 12 hours in 50 mL of normal saline for four days or until ICU discharge (whichever happens first, nine dose maximum). | Drug | TREATMENT with Vitamins C and B1 |
Primary outcome
Mortality Rates
Time frame: From time of treatment to 30 days post hospital discharge, up to 87 days.
All-cause mortality from time of enrollment/treatment to 30 days post hospital discharge (up to 87 days)
5 secondary outcomes
Hospital Length of Stay
Time frame: From admission to the hospital through hospital discharge, up to 57 days.
Intensive Care Unit Length of Stay
Time frame: From time of admission to the ICU through discharge from the ICU, up to 25 days
Readmission Rate
Time frame: 30 days after hospital discharge
Ventilator Days
Time frame: From admission to the ICU through discharge from the ICU, up to 25 days.
Hours on Vasopressors
Time frame: From admission to the ICU through discharge from the ICU, up to 25 days.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
David Shapiro, MD principal investigator
Saint Francis Hospital and Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Vitamin C and Vitamin B1 in people with Sepsis and Septic Shock, run by Trinity Health Of New England at 1 site 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 0 inclusion and 8 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 28 Sep 2022. 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 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. 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 28 Sep 2022). 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?
Mortality Rates (time frame: From time of treatment to 30 days post hospital discharge, up to 87 days.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 28 Sep 2022.