Back to resultsVitamin C to Reduce Vasopressor Dose in Septic Shock (ViCiS)
Primary Purpose
Septic Shock, Sepsis
Status
Unknown status
Phase
Phase 3
Locations
Mexico
Study Type
Interventional
Intervention
Vitamin C
Placebos
Sponsored by
About this trial
This is an interventional treatment trial for Septic Shock focused on measuring critical care, vitamin C, vasopressor, intensive care unit
Eligibility Criteria
Inclusion Criteria:
- Adults
- Septic Shock
Exclusion Criteria:
- Previous treatment exceeded 24 hours
- Refusal to participate
- Do Not Resuscitate
- Participation in another trial
Sites / Locations
- Hospital Español
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Vitamin C
Control
Arm Description
Vitamin C experimental group
Placebos Controlled group
Outcomes
Primary Outcome Measures
Vasopressor dose
Hourly dose of exogenous vasopressor
Secondary Outcome Measures
Hours of vasopressor use
Total hours of vasopressor use
Days of mechanical ventilation
Total days of mechanical ventilation use
Days of Intensive Care Unit stay
Total days of intensive care unit stay
Mortality in Intensive Care Unit
Rate of intensive care mortality
Full Information
NCT ID
NCT03835286
First Posted
January 22, 2019
Last Updated
July 28, 2020
Sponsor
Hospital Español de Mexico
1. Study Identification
Unique Protocol Identification Number
NCT03835286
Brief Title
Vitamin C to Reduce Vasopressor Dose in Septic Shock
Acronym
ViCiS
Official Title
Vitamin C to Reduce Exogenous Vasopressor Dose in Septic Shock; a Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
July 2020
Overall Recruitment Status
Unknown status
Study Start Date
March 1, 2019 (Actual)
Primary Completion Date
April 2021 (Anticipated)
Study Completion Date
June 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Español de Mexico
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Septic Shock, Sepsis
Keywords
critical care, vitamin C, vasopressor, intensive care unit
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
180 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Vitamin C
Arm Type
Experimental
Arm Description
Vitamin C experimental group
Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
Placebos Controlled group
Intervention Type
Drug
Intervention Name(s)
Vitamin C
Other Intervention Name(s)
Ascorbic Acid
Intervention Description
6 grams of Vitamin C in 250 ml of 0.9% saline in continuous infusion for 24 hours, 3 doses.
Intervention Type
Drug
Intervention Name(s)
Placebos
Other Intervention Name(s)
Placebo
Intervention Description
Placebos: 250 ml of 0.9% saline in continuous infusion for 24 hours, 3 doses.
Primary Outcome Measure Information:
Title
Vasopressor dose
Description
Hourly dose of exogenous vasopressor
Time Frame
72 hours
Secondary Outcome Measure Information:
Title
Hours of vasopressor use
Description
Total hours of vasopressor use
Time Frame
through study completion, an average of 30 days
Title
Days of mechanical ventilation
Description
Total days of mechanical ventilation use
Time Frame
through study completion, an average of 30 days
Title
Days of Intensive Care Unit stay
Description
Total days of intensive care unit stay
Time Frame
through study completion, an average of 30 days
Title
Mortality in Intensive Care Unit
Description
Rate of intensive care mortality
Time Frame
through study completion, an average of 30 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adults
Septic Shock
Exclusion Criteria:
Previous treatment exceeded 24 hours
Refusal to participate
Do Not Resuscitate
Participation in another trial
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ricardo Martinez-Zubieta, MD
Organizational Affiliation
Hospital Español de Mexico
Official's Role
Study Chair
Facility Information:
Facility Name
Hospital Español
City
Mexico City
ZIP/Postal Code
11520
Country
Mexico
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Complete database will be shared as requested by the publishing journal, once the study is completed
IPD Sharing Time Frame
Available one year after
IPD Sharing Access Criteria
Journal provided
Learn more about this trial
Vitamin C to Reduce Vasopressor Dose in Septic Shock
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