Vitamin C to Reduce Vasopressor Dose in Septic Shock (ViCiS)

January 16, 2024 updated by: Jose J Zaragoza, MD, Hospital Español de Mexico

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

Withdrawn

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

Interventional

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Mexico
      • Mexico City, Mexico, 11520
        • Hospital Español

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
Drug: Vitamin C
6 grams of Vitamin C in 250 ml of 0.9% saline in continuous infusion for 24 hours, 3 doses.
Other Names:
  • Ascorbic Acid
Placebo Comparator: Control
Placebos Controlled group
Drug: Placebos
Placebos: 250 ml of 0.9% saline in continuous infusion for 24 hours, 3 doses.
Other Names:
  • Placebo

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

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Español de Mexico

Investigators

  • Study Chair: Ricardo Martinez-Zubieta, MD, Hospital Español de Mexico

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2019

Primary Completion (Estimated)

December 1, 2022

Study Completion (Estimated)

December 1, 2022

Study Registration Dates

First Submitted

January 22, 2019

First Submitted That Met QC Criteria

February 7, 2019

First Posted (Actual)

February 8, 2019

Study Record Updates

Last Update Posted (Actual)

January 18, 2024

Last Update Submitted That Met QC Criteria

January 16, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EHE0042

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD 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

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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