Sepsis, Septic Shock
Conditions
Keywords
critical care, vitamin C, vasopressor, intensive care unit
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
Interventions
DRUGVitamin C
6 grams of Vitamin C in 250 ml of 0.9% saline in continuous infusion for 24 hours, 3 doses.
DRUGPlacebos
Placebos: 250 ml of 0.9% saline in continuous infusion for 24 hours, 3 doses.
Sponsors
Hospital Español de Mexico
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Adults * Septic Shock
Exclusion criteria
* Previous treatment exceeded 24 hours * Refusal to participate * Do Not Resuscitate * Participation in another trial
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Vasopressor dose | 72 hours | Hourly dose of exogenous vasopressor |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Mexico
Outcome results
None listed