Vitamin C, Hydrocortisone and Thiamine in Patients With Septic Shock

• Status: Recruiting
• Trial end date: 2023-12-20
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hospital Sirio-Libanes
• Collaborators: Ministry of Health, Brazil; PROADI-SUS
• Treatments: Ascorbic Acid; Hydrocortisone; Thiamine

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.