Sepsis Clinical Trial
— VITAMINSOfficial title:
The VitamIn C, HydrocorTisone and ThiAMINe in Patients With Septic Shock Trial (VITAMINS Trial) - A Prospective, Feasibility, Pilot, Multi-centre, Randomised, Open-label Controlled Trial
Verified date | October 2019 |
Source | Australian and New Zealand Intensive Care Research Centre |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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 demonstrate consistent benefit, and sepsis continues to manifest poor
outcomes. Hospital mortality in patients with septic shock remains as high as 22% in
Australia and New Zealand. From a global perspective, 31 million sepsis and 19 million severe
sepsis cases are expected to be treated in hospitals all over the world per year.
To date, experimental data have reported that both high dose intravenous vitamin C and
corticosteroids attenuate the acceleration of the inflammatory cascade and possibly reduce
the endothelial injury characteristic of sepsis, enhance the release of endogenous
catecholamines and improve vasopressor responsiveness.
Therefore, 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 dose Vitamin C (6g/d), Thiamine (400mg/d) and
Hydrocortisone (200mg/d) leads to a more rapid resolution shock and vasopressor dependence.
Status | Completed |
Enrollment | 216 |
Est. completion date | October 6, 2019 |
Est. primary completion date | July 16, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: 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 Criteria: 1. Age < 18 years 2. Pregnancy 3. DNR (do not resuscitate)/DNI (do not intubate) orders 4. 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 5. Patients with known HIV infection 6. Patients with known glucose-6 phosphate dehydrogenase (G-6PD) deficiency 7. Patients transferred from another ICU or hospital with a diagnosis of a septic shock for > 24 hours 8. Patients with a diagnosis of a septic shock for > 24 hours 9. 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 10. Clinician expects to prescribe systemic glucocorticoids for an indication other than septic shock (not including nebulised or inhaled corticosteroid) 11. Patient is receiving treatment for systemic fungal infection or has documented Strongyloides infection at the time of randomisation 12. Patient with known chronic iron overload due to iron storage and other diseases 13. Patient previously enrolled in this study 14. Clinician expects to prescribe high dose vitamin C for another indication |
Country | Name | City | State |
---|---|---|---|
Australia | Monash Health (Monash Medical Centre and Dandenong Hospital) | Clayton | Victoria |
Australia | Geelong University Hospital | Geelong | Victoria |
Australia | Austin Health | Heidelberg | Victoria |
Australia | Alfred Hospital | Melbourne | Victoria |
Australia | Royal Melbourne Hospital | Melbourne | Victoria |
Australia | Western Health (Footscray & Sunshine Hospital) | Melbourne | Victoria |
Brazil | Cancer Institute of the State of São Paulo | São Paulo | |
New Zealand | Wellington Hospital | Wellington |
Lead Sponsor | Collaborator |
---|---|
Australian and New Zealand Intensive Care Research Centre | Austin Hospital, Melbourne Australia, Barwon Health, Melbourne Health, Monash Health, The Alfred, Wellington Hospital, Western Health, Australia |
Australia, Brazil, New Zealand,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Time alive and free of vasopressors at day 7 (168 hours) after randomization. | This is defined by the patient being alive at discontinuation of all vasopressors for at least 4 hours in the presence of a MAP>65 mmHg for the same 4 hour period as recorded in the ICU charts and censored at 7 days. If a patient dies while on vasopressor therapy, in such a patient, the time alive and vasopressor free time will be 0 - This approach will correct for the competing effect of mortality on duration of vasopressor therapy. | 7 days (168 hours) | |
Secondary | ICU mortality | Patient died during the ICU admission | 90 days after randomization | |
Secondary | Alive and ICU-free days at day 28 calculated as the number of days alive and out of the ICU to day 28 | Alive and ICU-free days calculated as the number of days alive and out of the ICU to day 28 | 28 days after randomization | |
Secondary | Hospital mortality | Patient died during the hospital admission | 90 days after randomization | |
Secondary | 28-day mortality | Patient died within 28 days after randomization | 28 days after randomization | |
Secondary | 90-day mortality | Patient died within 90 days after randomization | 90 days after randomization | |
Secondary | Delta of Sequential Organ Failure Assessment (SOFA) score at 72 hours | defined as the initial total SOFA* score minus the day three (72 hours) SOFA score *total SOFA = Sequential Organ Failure Assessment = sum of each organ system point score. The score is based on six different scores, one each for the respiratory, cardiovascular, hepatic, coagulation, renal and neurological systems. The organ scores are ranging from 0-4, with the best score being 0 and the worst being 4 points. The maximal (and worst) total SOFA score is 24 points. |
72 hours after randomization | |
Secondary | Hospital length of stay | Duration the patient stayed in the hospital | 90 days after randomization | |
Secondary | 28 day cumulative vasopressor free hours | Cumulative vasopressor free hours from shock resolution to day28 post randomisation | 28 days after randomization | |
Secondary | 28 day cumulative invasive mechanical ventilation free hours | Cumulative invasive mechanical ventilation-free hours during the 28 day period post randomisation | 28 days after randomization | |
Secondary | RRT duration | Length of renal replacement therapy dependency during the 28 day period post randomisation | 28 days after randomization |
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