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Effect of IV Vitamin C, Thiamine, and Steroids on Mortality of Septic Shock

NCT03828929 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 3

Last updated 2020-02-10

No results posted yet for this study

Summary

Preliminary studies show that giving a "cocktail" of intravenous vitamin C, vitamin B1, and steroids to critically ill patients with septic shock may dramatically improve mortality in those patients. These studies suffer from inadequate design due to lack of controls and blinding to prove the causal effect. Our goal is to conduct a prospective blinded randomized control trial to investigate whether this intervention truly effect outcomes.

Conditions

  • Septic Shock

Interventions

DRUG

Vitamin C

IV vitamin C, 1500mg in 50ml of normal saline every six hours, infused over one hour and IV Thiamine 200mg in 50ml of 5% dextrose every 12 hours, for 4 days or until discharge from the intensive care unit, whichever comes first.

DRUG

Normal saline

50ml of IV normal saline every six hours and 50ml of IV 5% dextrose every 12 hours, for 4 days or until discharge from the intensive care unit, whichever comes first.

Sponsors & Collaborators

  • New York Presbyterian Brooklyn Methodist Hospital

    lead OTHER

Principal Investigators

  • Liam Gross, DO · New York Presbyterian Brooklyn Methodist Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-10-15
Primary Completion
2020-01-28
Completion
2020-02-04
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03828929 on ClinicalTrials.gov