Vitamin C and Septic Shock

• Status: Completed
• Trial end date: 2020-08-10
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Minnesota; University of Minnesota - Clinical and Translational Science Institute
• Treatments: Ascorbic Acid; Vitamins

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