Vitamin C to Reduce Vasopressor Dose in Septic Shock

NCT03835286 | Withdrawn Phase 3

• 1 other identifier: EHE0042
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Septic Shock; Sepsis

Keywords

critical care; vitamin C; vasopressor; intensive care unit

Outcome Measures

Primary Outcomes (1)

• Vasopressor dose

  Hourly dose of exogenous vasopressor

  72 hours

Secondary Outcomes (4)

• Hours of vasopressor use

  through study completion, an average of 30 days

• Days of mechanical ventilation

  through study completion, an average of 30 days

• Days of Intensive Care Unit stay

  through study completion, an average of 30 days

• Mortality in Intensive Care Unit

  through study completion, an average of 30 days

Study Arms (2)

Vitamin C

EXPERIMENTAL

Vitamin C experimental group

Drug: Vitamin C

Control

PLACEBO COMPARATOR

Placebos Controlled group

Drug: Placebos

Interventions

Vitamin C DRUG

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

Also known as: Ascorbic Acid

Vitamin C

Placebos DRUG

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

Also known as: Placebo

Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults
• Septic Shock

You may not qualify if:

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

Sponsors & Collaborators

• Hospital Español de Mexico: lead

Study Sites (1)

Hospital Español

Mexico City, 11520, Mexico

Location

MeSH Terms

Conditions

Shock, Septic; Sepsis

Interventions

Ascorbic Acid

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Intervention Hierarchy (Ancestors)

Sugar Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids; Carbohydrates

Study Officials

• Ricardo Martinez-Zubieta, MD

  Hospital Español de Mexico

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: January 22, 2019
• First Posted: February 8, 2019
• Study Start: March 1, 2019
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2022
• Last Updated: January 18, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Available one year after
• Access Criteria: Journal provided

Locations

ME (1)