Status:
UNKNOWN
High-dose Intravenous Vitamin C in Patients With Septic Shock
Lead Sponsor:
Melbourne Health
Collaborating Sponsors:
Monash Medical Centre
The Florey Institute of Neuroscience and Mental Health
Conditions:
Sepsis, Severe
Septic Shock
Eligibility:
All Genders
18-80 years
Phase:
PHASE1
Brief Summary
Despite promising observational and phase 1 data, the therapeutic potential of vitamin C for the management of septic shock has not borne out in recent large multi-centre randomized controlled trials....
Detailed Description
The investigators plan to conduct a phase 1, feasibility, prospective, two-centre, randomised, open-label, trial in 30 ICU patients with septic shock to test whether the intravenous administration of ...
Eligibility Criteria
Inclusion
- Diagnosis of septic shock within 24 hours of admission to the ICU
- Age 18 - 80 years
- Presence of a central venous catheter for vasopressor infusion
- Presence of an arterial line to monitor blood pressure
- Definition of sepsis Suspected or documented infection and an increase of ≥ 2 SOFA points consequent to the infection.
- Definition of septic shock Sepsis AND an arterial lactate \>2 mmol/L AND need for vasopressor therapy to keep MAP \>65 mmHg for \> 2 hours despite fluid resuscitation therapy.
Exclusion
- Age \<18 or \> 80 years
- Pregnant
- DNI (do not intubate) orders i.e., Goals of Care other than A
- Patients with a primary admission diagnosis of a traumatic brain injury
- Patients with features of septic shock admitted in the ICU \> 24 hours
- Patients with a known history of glucose-6 phosphate dehydrogenase (G-6PD) deficiency
- Patients with a history of renal stones
- Patients with known or suspected scurvy
- Patients previously enrolled in this study
- Plasma sodium \>150 mmol/L
- Plasma sodium \< 130 mmol/L
- Haemoglobin \< 90 g/L
- Jehova's witness
- Receiving isoprenaline
Key Trial Info
Start Date :
September 27 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 22 2023
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04796636
Start Date
September 27 2021
End Date
December 22 2023
Last Update
November 4 2022
Active Locations (1)
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1
Intensive Care Unit Royal Melbourne Hospital
Melbourne, Victoria, Australia, 3050