Vitamin C to Reduce Vasopressor Dose in Septic Shock

NCT ID: NCT03835286

Last Updated: 2024-01-18

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE3
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-03-01
• Study Completion Date: 2022-12-31

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

Conditions

Septic Shock; Sepsis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Vitamin C

Vitamin C experimental group

Group Type: EXPERIMENTAL

Vitamin C

Intervention Type: DRUG

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

Control

Placebos Controlled group

Group Type: PLACEBO_COMPARATOR

Placebos

Intervention Type: DRUG

Placebos: 250 ml of 0.9% saline in continuous infusion for 24 hours, 3 doses.

Interventions

Vitamin C

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

Intervention Type: DRUG

Placebos

Placebos: 250 ml of 0.9% saline in continuous infusion for 24 hours, 3 doses.

Intervention Type: DRUG

Other Intervention Names

Ascorbic Acid; Placebo

Eligibility Criteria

Inclusion Criteria

• Adults
• Septic Shock

Exclusion Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hospital Español de Mexico

OTHER

Sponsor Role: lead

Responsible Party

Jose J Zaragoza, MD

Clinical Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ricardo Martinez-Zubieta, MD

Role: STUDY_CHAIR

Hospital Español de Mexico

Locations

Hospital Español

Mexico City, , Mexico

Countries

Mexico

Other Identifiers

EHE0042

Identifier Type: -

Identifier Source: org_study_id