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Vitamin C, Hydrocortisone and Thiamine in Patients With Septic Shock - Trial NCT05192213

Access comprehensive clinical trial information for NCT05192213 through Pure Global AI's free database. This Phase 3 trial is sponsored by Hospital Sirio-Libanes and is currently Recruiting. The study focuses on Sepsis,Septic Shock. Target enrollment is 1090 participants.

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NCT05192213
Phase 3
Recruiting
drug
Trial Details
ClinicalTrials.gov โ€ข NCT05192213
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Vitamin C, Hydrocortisone and Thiamine in Patients With Septic Shock
Vitamin C, Hydrocortisone and Thiamine in Patients With Septic Shock: a Randomized Clinical Study (VITAMIN TRIAL)

Study Focus

Sepsis,Septic Shock

Vitamin C

Interventional

drug

Sponsor & Location

Hospital Sirio-Libanes

Fortaleza,Passos,Maringรก,Barretos,Sao Paulo, Brazil

Timeline & Enrollment

Phase 3

Aug 01, 2021

Dec 20, 2023

1090 participants

Primary Outcome

28-day Mortality

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.

ICD-10 Classifications

Septic shock
Other sepsis
Other specified sepsis
Sepsis, unspecified
Sepsis due to other specified staphylococcus

Data Source

ClinicalTrials.gov

NCT05192213

Non-Device Trial