- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03835286
Vitamin C to Reduce Vasopressor Dose in Septic Shock (ViCiS)
Vitamin C to Reduce Exogenous Vasopressor Dose in Septic Shock; a Randomized Clinical Trial
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.
Study Overview
Status
Conditions
Intervention / Treatment
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
Study Type
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
-
Mexico City, Mexico, 11520
- Hospital Español
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Adults
- Septic Shock
Exclusion Criteria:
- Previous treatment exceeded 24 hours
- Refusal to participate
- Do Not Resuscitate
- Participation in another trial
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Quadruple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Vitamin C
Vitamin C experimental group
|
6 grams of Vitamin C in 250 ml of 0.9% saline in continuous infusion for 24 hours, 3 doses.
Other Names:
|
Placebo Comparator: Control
Placebos Controlled group
|
Placebos: 250 ml of 0.9% saline in continuous infusion for 24 hours, 3 doses.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Vasopressor dose
Time Frame: 72 hours
|
Hourly dose of exogenous vasopressor
|
72 hours
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Hours of vasopressor use
Time Frame: through study completion, an average of 30 days
|
Total hours of vasopressor use
|
through study completion, an average of 30 days
|
Days of mechanical ventilation
Time Frame: through study completion, an average of 30 days
|
Total days of mechanical ventilation use
|
through study completion, an average of 30 days
|
Days of Intensive Care Unit stay
Time Frame: through study completion, an average of 30 days
|
Total days of intensive care unit stay
|
through study completion, an average of 30 days
|
Mortality in Intensive Care Unit
Time Frame: through study completion, an average of 30 days
|
Rate of intensive care mortality
|
through study completion, an average of 30 days
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Ricardo Martinez-Zubieta, MD, Hospital Español de Mexico
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- EHE0042
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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