Vitamin C to Reduce Vasopressor Dose in Septic Shock

Study Overview
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Brief Summary
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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
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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

Official Title
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Vitamin C to Reduce Exogenous Vasopressor Dose in Septic Shock; a Randomized Clinical Trial

Conditions
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Septic Shock, Sepsis

Intervention / Treatment
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* Drug: Vitamin C
* Drug: Placebos


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adults Septic Shock Exclusion Criteria: Previous treatment exceeded 24 hours Refusal to participate Do Not Resuscitate Participation in another trial

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Vitamin C<br>Vitamin C experimental group | Drug: Vitamin C<br>* 6 grams of Vitamin C in 250 ml of 0.9% saline in continuous infusion for 24 hours, 3 doses.<br>* Other names: Ascorbic Acid;|
| Placebo Comparator: Control<br>Placebos Controlled group | Drug: Placebos<br>* Placebos: 250 ml of 0.9% saline in continuous infusion for 24 hours, 3 doses.<br>* Other names: Placebo;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vasopressor dose | Hourly dose of exogenous vasopressor | 72 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hours of vasopressor use | Total hours of vasopressor use | through study completion, an average of 30 days | 
| Days of mechanical ventilation | Total days of mechanical ventilation use | through study completion, an average of 30 days | 
| Days of Intensive Care Unit stay | Total days of intensive care unit stay | through study completion, an average of 30 days | 
| Mortality in Intensive Care Unit | Rate of intensive care mortality | through study completion, an average of 30 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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critical care, vitamin C, vasopressor, intensive care unit