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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT03835286
Other study ID # EHE0042
Secondary ID
Status Withdrawn
Phase Phase 3
First received
Last updated
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
Health authority
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Status Withdrawn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

Study Design


Related Conditions & MeSH terms


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
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