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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

Tracking Information
First Submitted Date  ICMJE October 31, 2017
First Posted Date  ICMJE November 9, 2017
Results First Submitted Date  ICMJE June 14, 2021
Results First Posted Date  ICMJE July 14, 2021
Last Update Posted Date July 14, 2021
Actual Study Start Date  ICMJE December 20, 2017
Actual Primary Completion Date June 30, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 13, 2021)
  • 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
Original Primary Outcome Measures  ICMJE
 (submitted: November 8, 2017)
  • All Cause Mortality [ Time Frame: 4 days ]
  • All Cause Mortality [ Time Frame: 28 days ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 13, 2021)
  • Duration of Vasopressor Therapy [ Time Frame: 28 days ]
    Outcome is reported as the duration in hours of vasopressor therapy post intervention administration
  • 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
  • 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 ]
    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.
  • Rate of Procalcitonin Clearance Post Intervention Administration [ Time Frame: 4 days ]
  • 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
  • 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.
  • 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.
  • 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.
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: November 8, 2017)
  • Duration of vasopressor therapy post intervention administration [ Time Frame: 4 days ]
  • Duration of ICU stay post intervention administration [ Time Frame: 4 days ]
  • Time to lactate clearance post intervention administration [ Time Frame: 4 days ]
  • Rate of lactate clearance post intervention administration [ Time Frame: 4 days ]
  • Rate of procalcitonin clearance post intervention administration [ Time Frame: 4 days ]
  • Incidence of 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 ]
    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.
  • 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.
  • Total intravenous fluid administered [ Time Frame: 4 days ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures
 (submitted: November 8, 2017)
Effect of corticosteroids [ Time Frame: 4 days ]
 
Descriptive Information
Brief Title  ICMJE Vitamin C and Septic Shock
Official Title  ICMJE Evaluating Vitamin C in Septic Shock: A Randomized Double Blind Placebo Controlled Trial
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.
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  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Septic Shock
  • Sepsis
Intervention  ICMJE
  • Drug: Vitamin C
    Continuous infusion of vitamin C
    Other Name: ascorbic acid
  • Drug: Placebo
    Placebo designed to mimic intervention
Study Arms  ICMJE
  • Sham Comparator: Placebo
    Placebo designed to mimic intervention
    Intervention: Drug: Placebo
  • Active Comparator: Intervention
    6000 mg per day Vitamin C supplement
    Intervention: Drug: Vitamin C
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 14, 2021)
125
Original Estimated Enrollment  ICMJE
 (submitted: November 8, 2017)
140
Actual Study Completion Date  ICMJE August 10, 2020
Actual Primary Completion Date June 30, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03338569
Other Study ID Numbers  ICMJE STUDY00000625
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Current Responsible Party University of Minnesota
Original Responsible Party Same as current
Current Study Sponsor  ICMJE University of Minnesota
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University of Minnesota
Verification Date July 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP