Vitamin C to Reduce Vasopressor Dose in Septic Shock
- Registration Number
- NCT03835286
- Lead Sponsor
- Hospital Español de Mexico
- Brief Summary
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.
- Detailed 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 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
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
- Adults
- Septic Shock
- Previous treatment exceeded 24 hours
- Refusal to participate
- Do Not Resuscitate
- Participation in another trial
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Vitamin C Vitamin C Vitamin C experimental group Control Placebos Placebos Controlled group
- Primary Outcome Measures
Name Time Method Vasopressor dose 72 hours Hourly dose of exogenous vasopressor
- Secondary Outcome Measures
Name Time Method Hours of vasopressor use through study completion, an average of 30 days Total hours of vasopressor use
Days of mechanical ventilation through study completion, an average of 30 days Total days of mechanical ventilation use
Days of Intensive Care Unit stay through study completion, an average of 30 days Total days of intensive care unit stay
Mortality in Intensive Care Unit through study completion, an average of 30 days Rate of intensive care mortality
Trial Locations
- Locations (1)
Hospital Español
🇲🇽Mexico City, Mexico