Vitamin C to Reduce Vasopressor Dose in Septic Shock

Sepsis Clinical Trial

— ViCiS  

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03835286
• Other study ID #: EHE0042
• Status: Withdrawn
• Phase: Phase 3
• Start date: March 1, 2019
• Est. completion date: December 2022

Study information

• Verified date: January 2024
• Source: Hospital Español de Mexico
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2022
• Est. primary completion date: December 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adults
• Septic Shock

Exclusion Criteria:

• Previous treatment exceeded 24 hours
• Refusal to participate
• Do Not Resuscitate
• Participation in another trial

Related Conditions & MeSH terms

• Sepsis
• Septic Shock
• Shock
• Shock, Septic

Intervention

Drug:
• Vitamin C
6 grams of Vitamin C in 250 ml of 0.9% saline in continuous infusion for 24 hours, 3 doses.
• Placebos
Placebos: 250 ml of 0.9% saline in continuous infusion for 24 hours, 3 doses.

Locations

Country	Name	City	State
Mexico	Hospital Español	Mexico City

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Español de Mexico

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Vasopressor dose	Hourly dose of exogenous vasopressor	72 hours
Secondary	Hours of vasopressor use	Total hours of vasopressor use	through study completion, an average of 30 days
Secondary	Days of mechanical ventilation	Total days of mechanical ventilation use	through study completion, an average of 30 days
Secondary	Days of Intensive Care Unit stay	Total days of intensive care unit stay	through study completion, an average of 30 days
Secondary	Mortality in Intensive Care Unit	Rate of intensive care mortality	through study completion, an average of 30 days