A Phase 3 interventional study of Vitamin C and Placebos in Septic Shock and Sepsis, sponsored by Hospital Español de Mexico. Withdrawn at 1 site in Mexico. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-01-18.
Sponsored by Hospital Español de Mexico · Phase 3, Interventional, and Treatment
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.
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
862 studies on the registry are indexed under Shock, Septic; 207 are open to participants now.
Browse Shock, Septic studies →Hospital Español de Mexico is the lead sponsor of 2 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Vitamin C experimental group
Drug: Vitamin C
Placebos Controlled group
Drug: Placebos
6 grams of Vitamin C in 250 ml of 0.9% saline in continuous infusion for 24 hours, 3 doses.
Also known as: Ascorbic Acid
Placebos: 250 ml of 0.9% saline in continuous infusion for 24 hours, 3 doses.
Also known as: Placebo
Vasopressor dose
Hourly dose of exogenous vasopressor
Time frame: 72 hours
Hours of vasopressor use
Total hours of vasopressor use
Time frame: through study completion, an average of 30 days
Days of mechanical ventilation
Total days of mechanical ventilation use
Time frame: through study completion, an average of 30 days
Days of Intensive Care Unit stay
Total days of intensive care unit stay
Time frame: through study completion, an average of 30 days
Mortality in Intensive Care Unit
Rate of intensive care mortality
Time frame: through study completion, an average of 30 days
Plan to share: Yes — Complete database will be shared as requested by the publishing journal, once the study is completed
Supporting information: Study protocol, Sap, Icf
No publications or documents are linked to this record.
This study is withdrawn, as verified in Jan 2024. You cannot join it, but the record below documents what was studied.
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Hospital Español de Mexico