MedTrace Logo

Vitamin C, Hydrocortisone and Thiamine in Patients With Septic Shock

NCT05192213 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 71

Last updated 2024-01-30

No results posted yet for this study

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.

Conditions

Interventions

DRUG

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

OTHER

Placebo

Patients will receive 2 placebos (every 6 hours and every 12 hours) + Hydrocortisone (50 mg every 6 hours) for 7 days.

Sponsors & Collaborators

  • PROADI-SUS

    collaborator UNKNOWN

  • Ministry of Health, Brazil

    collaborator OTHER_GOV

  • Hospital Sirio-Libanes

    lead OTHER

Principal Investigators

  • Luciano CP Azevedo, PhD · Hospital Sirio-Libanês

  • Gisele Queiroz, MD · Hospitla Sirio-Libanês

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-08-01
Primary Completion
2022-07-14
Completion
2022-09-19

Countries

  • Brazil

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05192213 on ClinicalTrials.gov