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

NCT03828929 | Terminated Phase 3 DMC FDA Drug

• 1 other identifier: 1220432
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Hospital Mortality

  In Hospital Mortality

  All Cause in Hospital Mortality average 30 days

Study Arms (2)

Vitamin C and Thiamine

EXPERIMENTAL

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: Vitamin C

Placebo

PLACEBO COMPARATOR

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.

Drug: Normal saline

Interventions

Vitamin C DRUG

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.

Also known as: Thiamine

Vitamin C and Thiamine

Normal saline DRUG

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.

Also known as: 5% dextrose

Placebo

Eligibility Criteria

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

You may qualify if:

• Patients admitted to medical intensive care unit (MICU) for less than 24 hours, who are hypotensive despite a fluid bolus of 30 mL/kg and who are requiring pressors to keep MAP \> 65 of at least 5 mcg/min of levophed or equivalent and whose shock is clinically suspected to be secondary to sepsis.
• In addition, stress dose corticosteroids, hydrocortisone 50mg IV Q6hrs, will have to have been started or intended to be started.

You may not qualify if:

• Contraindication to corticosteroids, thiamine, or vitamin C
• Treating physician opposed to administering corticosteroids to the patient
• Age \< 18 years
• Pregnancy
• DNR/DNI/limitations of care
• Patients with a fatal underlying disease who are unlikely to survive to hospital discharge
• Patients with a primary admitting diagnosis of an acute cerebral vascular event, acute coronary syndrome, active gastrointestinal bleeding, burn or trauma
• Requirement for immediate surgery
• Patients with HIV and a CD4 \< 50 mm2
• Patients with known glucose-6 phosphate dehydrogenase (G-6PD) deficiency.8
• Involvement in another clinical trial

Sponsors & Collaborators

• New York Presbyterian Brooklyn Methodist Hospital: lead

Study Sites (1)

New York Methodist Hospital

Brooklyn, New York, 11215, United States

Location

Related Publications (2)

• Singer M, Deutschman CS, Seymour CW, Shankar-Hari M, Annane D, Bauer M, Bellomo R, Bernard GR, Chiche JD, Coopersmith CM, Hotchkiss RS, Levy MM, Marshall JC, Martin GS, Opal SM, Rubenfeld GD, van der Poll T, Vincent JL, Angus DC. The Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3). JAMA. 2016 Feb 23;315(8):801-10. doi: 10.1001/jama.2016.0287.

  PMID: 26903338 BACKGROUND

• Marik PE, Khangoora V, Rivera R, Hooper MH, Catravas J. Hydrocortisone, Vitamin C, and Thiamine for the Treatment of Severe Sepsis and Septic Shock: A Retrospective Before-After Study. Chest. 2017 Jun;151(6):1229-1238. doi: 10.1016/j.chest.2016.11.036. Epub 2016 Dec 6.

  PMID: 27940189 BACKGROUND

MeSH Terms

Conditions

Shock, Septic

Interventions

Ascorbic Acid; Thiamine; Saline Solution; Glucose

Condition Hierarchy (Ancestors)

Sepsis; 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; Thiazoles; Sulfur Compounds; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrimidines; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Hexoses; Monosaccharides; Sugars

Study Officials

• Liam Gross, DO

  New York Presbyterian Brooklyn Methodist Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Pharmacist who prepares the medication is in charge of blinding randomization.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Instructor of Clinical Medicine, Principle Investigator

Model Details: Study is performed with 2 arms, interventional arm with thiamine and vitamin C, and the control arm with placebo in a 1:1 ratio.

Study Record Dates

• First Submitted: January 29, 2019
• First Posted: February 4, 2019
• Study Start: October 15, 2019
• Primary Completion: January 28, 2020
• Study Completion: February 4, 2020
• Last Updated: February 10, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)