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Vitamin C and Septic Shock

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ClinicalTrials.gov Identifier: NCT03338569
Recruitment Status : Completed
First Posted : November 9, 2017
Results First Posted : July 14, 2021
Last Update Posted : July 14, 2021
Sponsor:
Information provided by (Responsible Party):
University of Minnesota

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Septic Shock Sepsis Drug: Vitamin C Drug: Placebo Phase 2 Phase 3

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
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 125 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Evaluating Vitamin C in Septic Shock: A Randomized Double Blind Placebo Controlled Trial
Actual Study Start Date : December 20, 2017
Actual Primary Completion Date : June 30, 2020
Actual Study Completion Date : August 10, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Shock Vitamin C

Arms and Interventions
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Arm Intervention/treatment
Sham Comparator: Placebo
Placebo designed to mimic intervention
 Drug: Placebo
Placebo designed to mimic intervention
Active Comparator: Intervention
6000 mg per day Vitamin C supplement
 Drug: Vitamin C
Continuous infusion of vitamin C
Other Name: ascorbic acid


Outcome Measures
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Primary Outcome Measures :
  1. 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).

  2. 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


Secondary Outcome Measures :
  1. Duration of Vasopressor Therapy [ Time Frame: 28 days ]
    Outcome is reported as the duration in hours of vasopressor therapy post intervention administration

  2. Duration of ICU Stay Post Intervention Administration [ Time Frame: 28 days ]
    Outcome is reported as the duration (in days) that participants require care in the intensive care unit (ICU) post intervention administration

  3. Time to Lactate Clearance Post Intervention Administration [ Time Frame: 28 days ]
  4. Rate of Lactate Clearance Post Intervention Administration [ Time Frame: 24, 48, 72, and 96 hours post intervention ]
    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.

  5. Rate of Procalcitonin Clearance Post Intervention Administration [ Time Frame: 4 days ]
  6. Number of Participants With Need for Renal Replacement Therapy [ Time Frame: 4 days ]
    Outcome is reported as the number of participants who require renal replacement therapy

  7. Change in Serum Creatinine [ Time Frame: Baseline and 4 days ]
    Outcome is report as the change in serum creatinine between baseline and 4 days following treatment. Outcome is reported in units of mg/dl.

  8. Change in Sequential Organ Failure Assessment (SOFA) Score [ Time Frame: Baseline and 4 days ]
    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.

  9. Change in Acute Physiology and Chronic Health Evaluation (APACHE) Scores [ Time Frame: Baseline and 4 days ]
    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.

  10. Total Intravenous Fluid Administered [ Time Frame: 24 hours ]
    Outcome is reported as the total volume of intravenous fluid (in liters) administered to participants during 24 hours following the initiation of study treatment.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • • 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

    • 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.

Exclusion Criteria:

  • • 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
    • 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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03338569


Locations
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United States, Minnesota
University of Minnesota Medical Center
Minneapolis, Minnesota, United States, 55455
Sponsors and Collaborators
University of Minnesota
  Study Documents (Full-Text)

Documents provided by University of Minnesota:
Study Protocol and Statistical Analysis Plan  [PDF] March 17, 2020
Informed Consent Form  [PDF] January 23, 2020

More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: University of Minnesota
ClinicalTrials.gov Identifier: NCT03338569    
Other Study ID Numbers: STUDY00000625
First Posted: November 9, 2017    Key Record Dates
Results First Posted: July 14, 2021
Last Update Posted: July 14, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Shock, Septic
Shock
Pathologic Processes
Sepsis
Infections
Systemic Inflammatory Response Syndrome
Inflammation
 Ascorbic Acid
Vitamins
Micronutrients
Physiological Effects of Drugs
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents