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Vitamin C administration in severe sepsis

Vitamin C administration in severe sepsis: a pilot randomised controlled trial of vasopressor requirements

Status
Completed
Phases
Phase 1
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12617001184369
Enrollment
40
Registered
2017-08-11
Start date
2018-05-16
Completion date
2020-06-08
Last updated
2022-10-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Sepsis is a major health problem worldwide and in New Zealand. Despite a massive effort in recent years to develop therapies, none has as yet proven successful in reducing mortality in patients with sepsis, which currently remains the leading cause of death in most intensive care units. Studies indicate that critically ill patients, including those with sepsis, exhibit very low vitamin C levels compared to healthy people. Furthermore, recent preclinical trials and clinical studies indicate a potential role for vitamin C in decreasing inflammation, vasopressor requirements, and multiple organ failure, and improving outcomes in patients with severe sepsis and septic shock, including decreased mortality. Our study will be a double blind randomised placebo controlled trial to test the efficacy of intravenous (IV) vitamin C administration in patients with severe sepsis, with a specific focus on vasopressor requirements. Participants with severe sepsis will be recruited after being admitted to the Christchurch Hospital Intensive Care Unit (ICU). Forty participants will be randomised into two groups: IV vitamin C (100 mg/kg body weight/day) or IV placebo (1:1 ratio) for a duration of 4 days. Blood and urine samples will be collected daily from patients to measure vitamin C levels along with selected biomarkers of inflammation and organ function. The analyses of these biomarkers, which relate to the severity of sepsis, will determine whether levels are changed in patients who receive the intervention. Clinical outcomes will also be monitored; we hypothesise that the patients who receive vitamin C will have improved outcomes.

Interventions

Vitamin C (ASCOR L500) Dose: 25 mg/kg/6h (total: 100 mg/kg/d) Duration: 4 days Mode: intravenous infusion

Sponsors

Dr Anitra Carr
Lead SponsorIndividual

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

1. Receiving IV antimicrobial therapy specifically for infection 2. Receiving >/=5 µg/min (>/=0.06 µg/kg/min) noradrenaline/adrenaline 3. Evidence of organ dysfunction - SOFA >/= 2 for at least ONE of: respiratory system (PaO2/FiO2 < 300) liver (bilirubin >33) coagulation (platelets <100) renal system (creatinine >171)

Exclusion criteria

1. Age < 18 years 2. Consent cannot be obtained 3. Patient not expected to survive 24 hours 4. Known glucose-6-phosphate dehydrogenase (G6PD) deficiency 5. Known or suspected pregnancy or breastfeeding

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 19, 2026