Vitamin C and Septic Shock

University of Minnesota (UMN)

Status and phase: Completed; Phase 3; Phase 2

Conditions: Septic Shock; Sepsis

Treatments: Drug: Placebo; Drug: Vitamin C

Study type: Interventional

Funder types: Other

Identifiers

NCT03338569

STUDY00000625

Details and patient eligibility

About

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.

Full 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.

Enrollment: 125 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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125 participants in 2 patient groups

Placebo

Sham Comparator group

Description:

Placebo designed to mimic intervention

Treatment:

Drug: Placebo

Intervention

Active Comparator group

Description:

6000 mg per day Vitamin C supplement

Treatment:

Drug: Vitamin C