Septic ShockPhase 2/3NCT03338569
Vitamin C and Septic Shock
A Phase 2/3 study testing Vitamin C in people with Septic Shock and Sepsis, run by University of Minnesota at 1 site in United States.
Trial summary
This is a randomized, double-blind, placebo-controlled clinical trial to compare Vitamin C versus placebo for patients presenting to the ICU with a diagnosis of septic shock. 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
- 125 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Dec 2017to 10 Aug 2020
- Phase
- Phase 2/3
- 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
- • Capability to provide written consent from participant or legally authorized representative (LAR) if the participant is unable or incapacitated due to severity of illness.
- Age ≥ 18 years
- Septic shock as pragmatically defined as:
- o Order for intravenous antimicrobials with either procalcitonin > 2 mg/dL within 24 hours of enrollment OR other clinical suspicion of infection or confirmed infection AND
- Hypotension requiring vasopressor therapy, despite fluid resuscitation of at least 30 cc/kg AND
- Lactate > 2 mmol/L 24 hr prior to enrollment AND
Show all 9Show fewer
- Presence of sepsis defined as equal to or greater than 2 SIRS criteria and/or acute increase in qSOFA score of 2 points or more.
- SIRS criteria: 1) Temperature greater than 38° or less than 36° Celsius. 2) Heart rate greater than 90 beats per minute. 3) Respiratory rate greater than 20 breaths per minute OR arterial carbon dioxide tension less than 32 mmHg. 4) White blood cell count greater than 12,000 cell/µL, less than 4,000 cells/µL, OR band cells greater than 10% of the total white blood cell population.
- qSOFA: 1 point each is assigned for: 1) systolic blood pressure below 100, 2) respiratory rate greater than 22, and 3) mental status not at baseline.
Who cannot join
- • Unable to start infusion within 24 hours of septic shock identification
- Currently pregnant or breastfeeding
- Patient to receive comfort measures only
- Cardiac Arrest
- Cardiovascular Surgery patients receiving prophylactic peri-operative antibiotics < 48 hours post-operation
- Participation in another study involving an investigational product within 30 days of the baseline visit
Show all 11Show fewer
- Allergy to Vitamin C
- History of nephrolithiasis
- History of G6PD deficiency
- ESRD patients, transplant eligible on dialysis currently taking vitamin C supplementation
- Clinical course that treating clinician decides would preclude safe participation
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Minnesota Medical Center
Minneapolis, Minnesota, 55455
About this study
Official title: Evaluating Vitamin C in Septic Shock: A Randomized Double Blind Placebo Controlled Trial
This is a randomized, double-blind, placebo-controlled clinical trial to compare Vitamin C versus placebo for patients presenting to the ICU with a diagnosis of septic shock.
Read the detailed description
This is a multi-site, randomized, double-blind, placebo-controlled trial comparing a regimen of moderate-dose (6000 mg per day) Vitamin C supplementation versus placebo for the treatment of patients presenting to the ICU with septic shock. Both groups will continue to receive all other standard of care measures for septic shock as clinically indicated. Groups will be enrolled and receive study drug/placebo for 4 days (96 hours) or until 24 hours post-last pressor dose, whichever is sooner.
- Conditions
- Septic Shock, Sepsis
- Being tested
- Vitamin C, Placebo
- 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
Continuous infusion of vitamin C
PlaceboDrug
Placebo designed to mimic intervention
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Sham comparator | Placebo designed to mimic intervention Receives: Drug: Placebo |
| Intervention | Active comparator | 6000 mg per day Vitamin C supplement Receives: Drug: Vitamin C |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With ICU Mortality
Outcome is reported as the number of patients who expired while receiving care in the intensive care unit (ICU).
Measured: 28 days
All Cause Mortality at 28 Days
Outcome is reported as the number of participants who have expired at 28 days post intervention
Measured: 28 days
Secondary outcomes (10)
Duration of Vasopressor Therapy
Outcome is reported as the duration in hours of vasopressor therapy post intervention administration
Measured: 28 days
Duration of ICU Stay Post Intervention Administration
Outcome is reported as the duration (in days) that participants require care in the intensive care unit (ICU) post intervention administration
Measured: 28 days
Time to Lactate Clearance Post Intervention Administration
Measured: 28 days
Rate of Lactate Clearance Post Intervention Administration
Outcome is reported as the number of participants who clear lactate from the bloodstream at 24, 48, 72, and 96 hours post intervention. Clearance is defined as a serum concentration of 2.0 mmol/l or less.
Measured: 24, 48, 72, and 96 hours post intervention
Rate of Procalcitonin Clearance Post Intervention Administration
Measured: 4 days
Number of Participants With Need for Renal Replacement Therapy
Outcome is reported as the number of participants who require renal replacement therapy
Measured: 4 days
Change in Serum Creatinine
Outcome is report as the change in serum creatinine between baseline and 4 days following treatment. Outcome is reported in units of mg/dl.
Measured: Baseline and 4 days
Change in Sequential Organ Failure Assessment (SOFA) Score
SOFA score is a mortality prediction score that is based on the degree of dysfunction of 6 organ systems. Total scores range from 0 to 24, with higher scores indicating higher likely mortality.
Measured: Baseline and 4 days
Change in Acute Physiology and Chronic Health Evaluation (APACHE) Scores
APACHE score is a severity-of-disease classification system that is calculated from a patient's age and 12 routine physiological measurements. Total scores are computed based on several measurements and range from 0 to 71 with higher scores corresponding to more severe disease and a higher risk of death.
Measured: Baseline and 4 days
Total Intravenous Fluid Administered
Outcome is reported as the total volume of intravenous fluid (in liters) administered to participants during 24 hours following the initiation of study treatment.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2017
- Study start20 Dec 2017
- Primary completion30 Jun 2020
- Study completion10 Aug 2020
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.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 125 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03338569
- Sponsor's protocol ID
- STUDY00000625
- Status last verified
- Jul 2021
- First submitted
- 31 Oct 2017
- Last updated
- 14 Jul 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Wacker DA, Burton SL, Berger JP, Hegg AJ, Heisdorffer J, Wang Q, Medcraft EJ, Reilkoff RA. Evaluating Vitamin C in Septic Shock: A Randomized Controlled Trial of Vitamin C Monotherapy. Crit Care Med. 2022 May 1;50(5):e458-e467. doi: 10.1097/CCM.0000000000005427. Epub 2022 Jan 5.
PubMed 34982738
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Vitamin C in Septic Shock: A Randomized Double Blind Placebo Controlled Trial
- ClinicalTrials.gov ID
- NCT03338569
- Acronym / sponsor ID
- STUDY00000625
- Conditions
- Septic Shock, Sepsis
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 125 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Study start
- 20 Dec 2017 (actual)
- Primary completion
- 30 Jun 2020 (actual)
- Study completion
- 10 Aug 2020 (actual)
- First posted
- 9 Nov 2017 (actual)
- Results
- Posted 14 Jul 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a randomized, double-blind, placebo-controlled clinical trial to compare Vitamin C versus placebo for patients presenting to the ICU with a diagnosis of septic shock.
Detailed description
This is a multi-site, randomized, double-blind, placebo-controlled trial comparing a regimen of moderate-dose (6000 mg per day) Vitamin C supplementation versus placebo for the treatment of patients presenting to the ICU with septic shock. Both groups will continue to receive all other standard of care measures for septic shock as clinically indicated. Groups will be enrolled and receive study drug/placebo for 4 days (96 hours) or until 24 hours post-last pressor dose, whichever is sooner.
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 |
|---|---|---|
| Placebo | Sham comparator | Drug: PlaceboPlacebo designed to mimic intervention |
| Intervention | Active comparator | Drug: Vitamin C6000 mg per day Vitamin C supplement |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- • Capability to provide written consent from participant or legally authorized representative (LAR) if the participant is unable or incapacitated due to severity of illness.
- o Order for intravenous antimicrobials with either procalcitonin > 2 mg/dL within 24 hours of enrollment OR other clinical suspicion of infection or confirmed infection AND
Key exclusion criteria (11 listed)
- • Unable to start infusion within 24 hours of septic shock identification
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 acidContinuous infusion of vitamin C | Drug | Intervention |
| PlaceboPlacebo designed to mimic intervention | Drug | Placebo |
Primary outcome
Number of Participants With ICU Mortality
Time frame: 28 days
Outcome is reported as the number of patients who expired while receiving care in the intensive care unit (ICU).
All Cause Mortality at 28 Days
Time frame: 28 days
Outcome is reported as the number of participants who have expired at 28 days post intervention
10 secondary outcomes
Duration of Vasopressor Therapy
Time frame: 28 days
Duration of ICU Stay Post Intervention Administration
Time frame: 28 days
Time to Lactate Clearance Post Intervention Administration
Time frame: 28 days
Rate of Lactate Clearance Post Intervention Administration
Time frame: 24, 48, 72, and 96 hours post intervention
Rate of Procalcitonin Clearance Post Intervention Administration
Time frame: 4 days
Number of Participants With Need for Renal Replacement Therapy
Time frame: 4 days
Change in Serum Creatinine
Time frame: Baseline and 4 days
Change in Sequential Organ Failure Assessment (SOFA) Score
Time frame: Baseline and 4 days
Change in Acute Physiology and Chronic Health Evaluation (APACHE) Scores
Time frame: Baseline and 4 days
Total Intravenous Fluid Administered
Time frame: 24 hours
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jul 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34982738Wacker DA, Burton SL, Berger JP, Hegg AJ, Heisdorffer J, Wang Q, Medcraft EJ, Reilkoff RA. Evaluating Vitamin C in Septic Shock: A Randomized Controlled Trial of Vitamin C Monotherapy. Crit Care Med. 2022 May 1;50(5):e458-e467. doi: 10.1097/CCM.0000000000005427. Epub 2022 Jan 5.
- Individual participant dataSharing planned: Undecided
Related trials for Septic Shock
Recruiting
Veno-arterial Carbon Dioxide Partial Pressure Difference (CO2gap) for Early Resuscitation of Septic Shock
Sepsis - to Reduce Mortality in the Intensive Care Unit, Septic Shock
Not yet recruiting
Hemodynamic Resuscitation Guided by Non-Invasive Mean Systemic Filling Pressure to Prevent Acute Kidney Injury in Septic Shock
Acute Kidney Injury Due to Sepsis
RecruitingObservational study
Clinical Value of EMR3 in Sepsis Diagnosis, Monitoring, and Prognosis: A Multicenter Prospective Observational Study
Sepsis
RecruitingObservational study
Comparison of Cardiac Index Measurement Using Right Ventricular Pressure Curve Analysis and Thermodilution Via a Swan-Ganz IQ™ Catheter.
Septic Shock
RecruitingPhase 3
A Trial of Adjunctive Fludrocortisone (50mcg, 100mcg or Placebo) in Critically Ill Patients With Septic Shock Receiving Hydrocortisone, Evaluating Survival and Functional Recovery and the Influence of Transcriptomic Response
Septic Shock
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Vitamin C in people with Septic Shock and Sepsis, run by University of Minnesota 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 9 inclusion and 11 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 14 Jul 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 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 combined 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.
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 14 Jul 2021). 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?
Number of Participants With ICU Mortality (time frame: 28 days). The study lists 2 primary outcomes in all. 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 NCT03338569, 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 14 Jul 2021.