Vitamin C and Septic Shock

Completed · Phase 2/Phase 3 · Has a placebo group

Conditions studied: Septic Shock, Sepsis

In brief

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.

Key facts

Study ID

NCT03338569

Run by

University of Minnesota

People needed

125

Starts

2017-12-20

Expected to finish

2020-08-10

Last updated by the study team

2021-07-14

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• • 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.

You may not qualify if…

• • 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

Where it is running

• University of Minnesota Medical Center — Minneapolis, Minnesota, United States

Full record on ClinicalTrials.gov

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