Status:
COMPLETED
The Vitamin C, Hydrocortisone and Thiamine in Patients With Septic Shock Trial
Lead Sponsor:
Australian and New Zealand Intensive Care Research Centre
Collaborating Sponsors:
Austin Hospital, Melbourne Australia
Melbourne Health
Conditions:
Shock, Septic
Critically Ill
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Sepsis has been characterised as a dysregulated host response to infection. Adjunctive therapies targeting the inflammatory cascade are being increasingly explored, although to date, have failed to de...
Detailed Description
The investigators plan to conduct a feasibility pilot prospective, multi-centre, randomised, open-label, trial in ICU patients with septic shock to test whether the intravenous administration of high ...
Eligibility Criteria
Inclusion
- Patient in the intensive care unit (ICU) with septic shock:
- Blood lactate \>2 mmol/L, despite adequate fluid resuscitation AND
- need for continuous vasopressor therapy to keep mean arterial pressure (MAP) \>65 mmHg for \>2 hours
Exclusion
- Age \< 18 years
- Pregnancy
- DNR (do not resuscitate)/DNI (do not intubate) orders
- Death is deemed to be imminent or inevitable during this admission, and either the attending physician, patient or substitute decision-maker is not committed to active treatment
- Patients with known HIV infection
- Patients with known glucose-6 phosphate dehydrogenase (G-6PD) deficiency
- Patients transferred from another ICU or hospital with a diagnosis of a septic shock for \> 24 hours
- Patients with a diagnosis of a septic shock for \> 24 hours
- Patients with known or suspected
- a. history of oxalate nephropathy or hyperoxaluria
- b. short bowel syndrome or severe fat-malabsorption
- c. acute beri-beri disease
- d. acute Wernicke's encephalopathy
- e. malaria
- f. scurvy
- g. Addison's disease
- h. Cushing's disease
- Clinician expects to prescribe systemic glucocorticoids for an indication other than septic shock (not including nebulised or inhaled corticosteroid)
- Patient is receiving treatment for systemic fungal infection or has documented Strongyloides infection at the time of randomisation
- Patient with known chronic iron overload due to iron storage and other diseases
- Patient previously enrolled in this study
- Clinician expects to prescribe high dose vitamin C for another indication
Key Trial Info
Start Date :
May 2 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 6 2019
Estimated Enrollment :
216 Patients enrolled
Trial Details
Trial ID
NCT03333278
Start Date
May 2 2018
End Date
October 6 2019
Last Update
October 10 2019
Active Locations (8)
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1
Monash Health (Monash Medical Centre and Dandenong Hospital)
Clayton, Victoria, Australia, 3468
2
Geelong University Hospital
Geelong, Victoria, Australia
3
Austin Health
Heidelberg, Victoria, Australia, 3084
4
Alfred Hospital
Melbourne, Victoria, Australia, 3004