Clinical trial
Vitamin C, Hydrocortisone and Thiamine in Patients With Septic Shock: a Randomized Clinical Study (VITAMIN TRIAL)
Name
AVAP-NG 1000
Description
A great interest exists regarding substances with an immunomodulatory effect for sepsis patients. Recent data have shown that intravenous vitamin C, together with corticosteroids and thiamine, could prevent progressive organ dysfunction and reduce vasopressor use in patients with severe sepsis and septic shock. Its effect on mortality, on the other hand, is yet to be demonstrated. The Vitamins study aims to conclusively determine, through its prospective, multicentre and double-blinded design including 1090 patients, wether Vitamin C, Thiamine and Hydrocortisone in combination can reduce mortality in patients with septic shock.
Trial arms
Trial start
2021-08-01
Estimated PCD
2022-07-14
Trial end
2022-09-19
Status
Terminated
Phase
Early phase I
Treatment
Vitamin C
Patients will be allocated in a 1: 1 ratio to the treatment group, receiving intravenous Vitamin C (1.5 g every 6 hours), Thiamine (200 mg every 12 hours) and Hydrocortisone (50 mg every 6 hours) for 7 days
Arms:
Intervention
Other names:
thiamine, hydrocortisone
Placebo
Patients will receive 2 placebos (every 6 hours and every 12 hours) + Hydrocortisone (50 mg every 6 hours) for 7 days.
Arms:
Control
Size
71
Primary endpoint
28-day Mortality
28 days
Eligibility criteria
Inclusion Criteria:
* Above 18 years of age
* Sepsis of any background
* Vasopressor-dependent sepsis for at least 2 hours and vasopressor dose ≥ 0.25 µg / kg / min
Exclusion Criteria:
* Pregnancy;
* Requests for DNR (do not resuscitate) / DNI (do not intubate);
* Death is considered imminent or inevitable during this hospitalization and the attending physician, patient or substitute decision maker is not committed to active treatment;
* Patients with acute cerebral vascular event, acute coronary syndrome, active gastrointestinal bleeding, burn or trauma at admission;
* Patients with known HIV infection;
* Patients with known glucose-6 phosphate dehydrogenase (G-6PD) deficiency;
* Patients with septic shock transferred from another ICU or hospital with characteristics of septic shock for\> 12 hours;
* Patients with septic shock characteristics for\> 12 hours;
* Patients with a known history of oxalate nephropathy;
* Patients with short bowel syndrome or severe known fat malabsorption;
* Patients with acute beriberi disease;
* Patients with acute Wernicke's encephalopathy;
* Patients with known malaria;
* Patients with known or suspected scurvy;
* Patients with known or suspected Addison's disease;
* Patients with known Cushing's disease;
* Physician expects to prescribe or the patient has previously used (less than 15 days) systemic glucocorticoids for an indication other than septic shock (not including nebulized or inhaled corticosteroids), including the use of glucocorticoids for COVID-19;
* The patient is receiving treatment for systemic fungal infection or has documented Strongyloides infection at the time of randomization;
* Patient with known chronic iron overload due to iron storage and other diseases;
* Patient previously enrolled in this study.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 71, 'type': 'ACTUAL'}}
Updated at
2024-01-30
1 organization
1 product
2 indications
Organization
Hospital Sirio-LibanesProduct
Vitamin CIndication
SepsisIndication
Septic shock