Vitamin C, Hydrocortisone and Thiamine in Patients With Septic Shock

  • STATUS
    Recruiting
  • End date
    Dec 20, 2023
  • participants needed
    1090
  • sponsor
    Hospital Sirio-Libanes
Updated on 25 March 2022
corticosteroids
severe sepsis
shock
thiamine
vitamins
septic shock
vasoconstrictors

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.

Description

The global burden of sepsis is substantial with an estimated 15 to 19 million cases per year, most occurring in low-income countries. With recent advances in diagnosis and supportive treatment, the 28-day mortality from sepsis in high-income countries has decreased by about 25%; however, the mortality from septic shock still remains around 45%.

A large volume of experimental data has shown that both corticosteroids and intravenous vitamin C attenuate the release of pro-inflammatory mediators, reduce the endothelial lesion characteristic of sepsis (reducing endothelial permeability and improving microcirculatory flow), increase the release of endogenous catecholamines and improve vasopressor reaction. In animal models, these effects resulted in reduced organ damage and increased survival. However, its effect on critically ill humans is controvert. Results of a retrospective study brought that the early use of intravenous vitamin C, together with corticosteroids and thiamine, can prevent progressive organ dysfunction and can reduce mortality in patients with severe sepsis and septic shock.

For this reason, the investigators propose a randomized, controlled, multicentre (mcRCT), pragmatic and feasibility study to investigate whether Vitamin C (1.5g 6 / 6h), along with thiamine (200 mg, 12 / 12h) and hydrocortisone (50 mg 6 / 6h) for 7 days can reduce all-cause mortality within 28 days after randomization.

Details
Condition Sepsis, Septic Shock
Treatment Placebo, Vitamin C
Clinical Study IdentifierNCT05192213
SponsorHospital Sirio-Libanes
Last Modified on25 March 2022

Eligibility

Yes No Not Sure

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
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