Recruitment

Recruitment Status
Active, not recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Sepsis
  • Septic Shock
Type
Interventional
Phase
Phase 3
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 125 years
Gender
Both males and females

Description

Randomized, controlled, double blind clinical trial. Adult patients admitted to the ICU of the Hospital Español de México with a diagnosis of septic shock will be included. Patients will be randomized to one of the study groups: Intervention Group: Vitamin C 6 grams in 250 ml of 0.9% saline solution...

Randomized, controlled, double blind clinical trial. Adult patients admitted to the ICU of the Hospital Español de México with a diagnosis of septic shock will be included. Patients will be randomized to one of the study groups: Intervention Group: Vitamin C 6 grams in 250 ml of 0.9% saline solution every 24 hours, in continuous infusion for 72 hours. Placebo Group: 0.9% saline solution 250 ml every 24 hours, in continuous infusion for 72 hours. Bottles will be identical, only identified by the sequential number of the patient that has been included. Primary objective is to demonstrate that the administration of intravenous Vitamin C decreases the dose of exogenous vasopressors in patients with septic shock

Tracking Information

NCT #
NCT03835286
Collaborators
Not Provided
Investigators
Study Chair: Ricardo Martinez-Zubieta, MD Hospital Español de Mexico