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Vitamin C and Septic Shock

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ClinicalTrials.gov Identifier: NCT03338569
Recruitment Status : Recruiting
First Posted : November 9, 2017
Last Update Posted : February 26, 2018
Sponsor:
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute

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 Type : Interventional  (Clinical Trial)
Estimated Enrollment : 140 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
Estimated Primary Completion Date : November 20, 2019
Estimated Study Completion Date : March 20, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Shock Vitamin C

Arm Intervention/treatment
Sham Comparator: Placebo
Placebo designed to mimic intervention
Drug: Placebo
Placebo designed to mimic intervention

Active Comparator: Intervention
Vitamin C
Drug: Vitamin C
Continuous infusion of vitamin C
Other Name: ascorbic acid




Primary Outcome Measures :
  1. All Cause Mortality [ Time Frame: 28 days ]
    Days subject is confined to ICU


Secondary Outcome Measures :
  1. Duration of vasopressor therapy post intervention administration [ Time Frame: 28 days ]
  2. Duration of ICU stay post intervention administration [ Time Frame: 28 days ]
  3. Time to lactate clearance post intervention administration [ Time Frame: 28 days ]
  4. Rate of lactate clearance post intervention administration [ Time Frame: 4 days ]
  5. Rate of procalcitonin clearance post intervention administration [ Time Frame: 4 days ]
  6. Incidence of need for renal replacement therapy [ Time Frame: 28 days ]
  7. Change in serum creatinine [ Time Frame: Baseline and 4 days ]
  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. Minimum, mean, and maximum could be used in data analysis of change. The higher the SOFA score, the higher the 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. Minimum, mean, and maximum could be used in data analysis of change but an integer score from 0 to 71 is computed based on several measurements; higher scores correspond to more severe disease and a higher risk of death.

  10. Total intravenous fluid administered [ Time Frame: 4 days ]


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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

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


Contacts
Contact: Ronald Reilkoff, MD 612-624-0999 rreilkof@umn.edu

Locations
United States, Minnesota
University of Minnesota Medical Center Recruiting
Minneapolis, Minnesota, United States, 55455
Sponsors and Collaborators
University of Minnesota - Clinical and Translational Science Institute

Responsible Party: University of Minnesota - Clinical and Translational Science Institute
ClinicalTrials.gov Identifier: NCT03338569     History of Changes
Other Study ID Numbers: STUDY00000625
First Posted: November 9, 2017    Key Record Dates
Last Update Posted: February 26, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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:
Shock
Shock, Septic
Pathologic Processes
Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Vitamins
Ascorbic Acid
Micronutrients
Growth Substances
Physiological Effects of Drugs
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents