Septic ShockPhase 3ViCiSNCT03835286
Vitamin C to Reduce Vasopressor Dose in Septic Shock
A Phase 3 study testing Vitamin C in people with Septic Shock and Sepsis, run by Hospital Español de Mexico at 1 site in Mexico.
Trial summary
Randomized, controlled, double blind clinical trial. Adult patients admitted to the ICU of the Hospital Español de México with a diagnosis of septic shock will be included. Patients will be randomized to one of the study groups: Intervention Group: Vitamin C 6 grams in 250 ml of 0.9% saline solution every 24 hours, in… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Septic Shock, Sepsis
- 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
- 0 participants
- Where
- 1 siteMexico
- Study dates
- 1 Mar 2019to Dec 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
- Adults
- Septic Shock
Who cannot join
- Previous treatment exceeded 24 hours
- Refusal to participate
- Do Not Resuscitate
- Participation in another trial
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Vitamin C to Reduce Exogenous Vasopressor Dose in Septic Shock; a Randomized Clinical Trial
Randomized, controlled, double blind clinical trial. Adult patients admitted to the ICU of the Hospital Español de México with a diagnosis of septic shock will be included.
Patients will be randomized to one of the study groups:
Intervention Group: Vitamin C 6 grams in 250 ml of 0.9% saline solution every 24 hours, in continuous infusion for 72 hours.
Placebo Group: 0.9% saline solution 250 ml every 24 hours, in continuous infusion for 72 hours.
Read the detailed description
Randomized, controlled, double blind clinical trial. Adult patients admitted to the ICU of the Hospital Español de México with a diagnosis of septic shock will be included.
Patients will be randomized to one of the study groups:
Intervention Group: Vitamin C 6 grams in 250 ml of 0.9% saline solution every 24 hours, in continuous infusion for 72 hours.
Placebo Group: 0.9% saline solution 250 ml every 24 hours, in continuous infusion for 72 hours.
Bottles will be identical, only identified by the sequential number of the patient that has been included.
Primary objective is to demonstrate that the administration of intravenous Vitamin C decreases the dose of exogenous vasopressors in patients with septic shock
- Conditions
- Septic Shock, Sepsis
- Being tested
- Vitamin C, Placebos
- Keywords
- critical care, vitamin C, vasopressor, intensive care unit
- Medical subject headings
- Shock, Septic, 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
6 grams of Vitamin C in 250 ml of 0.9% saline in continuous infusion for 24 hours, 3 doses.
PlacebosDrug
Also called Placebo
Placebos: 250 ml of 0.9% saline in continuous infusion for 24 hours, 3 doses.
| Study group | Role | What they receive |
|---|---|---|
| Vitamin C | Experimental | Vitamin C experimental group Receives: Drug: Vitamin C |
| Control | Placebo comparator | Placebos Controlled group Receives: Drug: Placebos |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vasopressor dose
Hourly dose of exogenous vasopressor
Measured: 72 hours
Secondary outcomes (4)
Hours of vasopressor use
Total hours of vasopressor use
Measured: through study completion, an average of 30 days
Days of mechanical ventilation
Total days of mechanical ventilation use
Measured: through study completion, an average of 30 days
Days of Intensive Care Unit stay
Total days of intensive care unit stay
Measured: through study completion, an average of 30 days
Mortality in Intensive Care Unit
Rate of intensive care mortality
Measured: through study completion, an average of 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2019
- Study start1 Mar 2019
- Primary completionDec 2022 (estimated)
- Study completionDec 2022 (estimated)
Why it stopped: COVID 19
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Español de Mexico
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jose J Zaragoza, MD, Hospital Español de Mexico
- Investigators
- Ricardo Martinez-Zubieta, MD, Study chair, Hospital Español de Mexico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03835286
- Sponsor's protocol ID
- EHE0042
- Acronym
- ViCiS
- Status last verified
- Jan 2024
- First submitted
- 22 Jan 2019
- Last updated
- 18 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Complete database will be shared as requested by the publishing journal, once the study is completed
Study at a glance
From the registry record, last updated by the sponsor on 18 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vitamin C to Reduce Exogenous Vasopressor Dose in Septic Shock; a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03835286
- Acronym / sponsor ID
- ViCiS / EHE0042
- Conditions
- Septic Shock, Sepsis
- Keywords
- critical care, vitamin C, vasopressor, intensive care unit
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: COVID 19
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Hospital Español de MexicoUniversity, hospital or other
- Study start
- 1 Mar 2019 (actual)
- Primary completion
- Dec 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 8 Feb 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.
Randomized, controlled, double blind clinical trial. Adult patients admitted to the ICU of the Hospital Español de México with a diagnosis of septic shock will be included.
Patients will be randomized to one of the study groups:
Intervention Group: Vitamin C 6 grams in 250 ml of 0.9% saline solution every 24 hours, in continuous infusion for 72 hours.
Placebo Group: 0.9% saline solution 250 ml every 24 hours, in continuous infusion for 72 hours.
Detailed description
Randomized, controlled, double blind clinical trial. Adult patients admitted to the ICU of the Hospital Español de México with a diagnosis of septic shock will be included.
Patients will be randomized to one of the study groups:
Intervention Group: Vitamin C 6 grams in 250 ml of 0.9% saline solution every 24 hours, in continuous infusion for 72 hours.
Placebo Group: 0.9% saline solution 250 ml every 24 hours, in continuous infusion for 72 hours.
Bottles will be identical, only identified by the sequential number of the patient that has been included.
Primary objective is to demonstrate that the administration of intravenous Vitamin C decreases the dose of exogenous vasopressors in patients with 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 | Experimental | Drug: Vitamin CVitamin C experimental group |
| Control | Placebo comparator | Drug: PlacebosPlacebos Controlled group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adults
- Septic Shock
Key exclusion criteria (4 listed)
- Previous treatment exceeded 24 hours
- Refusal to participate
- Do Not Resuscitate
- Participation in another trial
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 Acid6 grams of Vitamin C in 250 ml of 0.9% saline in continuous infusion for 24 hours, 3 doses. | Drug | Vitamin C |
| PlacebosAlso: PlaceboPlacebos: 250 ml of 0.9% saline in continuous infusion for 24 hours, 3 doses. | Drug | Control |
Primary outcome
Vasopressor dose
Time frame: 72 hours
Hourly dose of exogenous vasopressor
4 secondary outcomes
Hours of vasopressor use
Time frame: through study completion, an average of 30 days
Days of mechanical ventilation
Time frame: through study completion, an average of 30 days
Days of Intensive Care Unit stay
Time frame: through study completion, an average of 30 days
Mortality in Intensive Care Unit
Time frame: through study completion, an average of 30 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jan 2024.
- Individual participant dataSharing planned: Yes. Complete database will be shared as requested by the publishing journal, once the study is completed
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.
Ricardo Martinez-Zubieta, MD study chair
Hospital Español de Mexico
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 in people with Septic Shock and Sepsis, run by Hospital Español de Mexico at 1 site in Mexico.
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 4 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: withdrawn, as of the sponsor's last update on 18 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 1 site in Mexico. 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 was withdrawn before enrolling participants, so there are no results.
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 dose (time frame: 72 hours). 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 18 Jan 2024.