Vitamin C & Thiamine to Treat Sepsis and Septic Shock

Vitamins B1 and C to Improve Outcomes in Patients With Severe Sepsis

Investigators propose to investigate the use of IV vitamins B1 and C in a randomized, double-blinded, prospective trial to determine if these medications decrease mortality rates in patients with severe sepsis or septic shock.

Study Overview

• Status: Completed
• Conditions: Sepsis; Septic Shock
• Intervention / Treatment: Drug: Vitamin C; Drug: Vitamin B1

Detailed Description

Investigators propose to investigate the use of IV vitamins B1 and C in a randomized, double-blinded, prospective trial to determine if these medications decrease mortality rates in patients with severe sepsis or septic shock. Patients experiencing evidence-based diagnoses of sepsis and severe sepsis and septic shock will be randomized to the two study arms for care, and all other care left to decisions of intensive care teams.

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Connecticut
    • Hartford, Connecticut, United States, 06105
      • Saint Francis Hospital and Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 88 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Patients must meet all inclusion criteria:

1. Between the ages of 18 and 90 years old
2. Have severe sepsis or septic shock. Severe sepsis and septic shock will be defined by the Surviving Sepsis 2012 guidelines.
3. Weight more than 30 kg
4. Full code

Exclusion Criteria:

1. Not diagnosed with severe sepsis or septic shock
2. Younger than 18 or older than 90 years old
3. With a history of nephrolithiasis
4. Who are pregnant
5. Weigh less than 30 kg
6. Not located in the ICU
7. Do not resuscitate (DNR) or do not intubate (DNI), no escalation of care, or comfort measures only (CMO)
8. Currently on dialysis

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: TREATMENT with Vitamins C and B1; Patients in the Vitamins C and B1 arm will receive 1.5g of vitamin C in 100mL of 0.9% sodium chloride (normal saline) every six hours for four days or until discharge from the ICU, whichever happens first (seventeen dose maximum). In addition, they will receive 200 mg IV vitamin B1 every 12 hours in 50 mL of normal saline for four days or until ICU discharge (whichever happens first, nine dose maximum).	Drug: Vitamin C; Patients will receive 1.5g of vitamin C in 100mL of 0.9% sodium chloride (normal saline) every six hours for four days or until discharge from the ICU, whichever happens first (seventeen dose maximum).; Other Names: Ascorbic Acid; Drug: Vitamin B1; Patients will also receive 200 mg of IV vitamin B1 every 12 hours in 50 mL of normal saline for four days or until ICU discharge (whichever happens first, nine dose maximum).; Other Names: Thiamine
No Intervention: PLACEBO with saline only; Patients in the placebo (control group) arm will receive the 100 mL of 0.9% sodium chloride every six hours and 50 mL of 0.9% sodium chloride every 12 hours to act as placebos for the vitamins C and B1 respectively.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mortality Rates	All-cause mortality from time of enrollment/treatment to 30 days post hospital discharge (up to 87 days)	From time of treatment to 30 days post hospital discharge, up to 87 days.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Hospital Length of Stay	Total number of days patient is admitted to the hospital	From admission to the hospital through hospital discharge, up to 57 days.
Intensive Care Unit Length of Stay	Total number of days patient is admitted to the ICU	From time of admission to the ICU through discharge from the ICU, up to 25 days
Readmission Rate	Readmission to the hospital within 30 days after discharge	30 days after hospital discharge
Ventilator Days	Number of days patient required ventilator	From admission to the ICU through discharge from the ICU, up to 25 days.
Hours on Vasopressors	Number of hours patient required vasopressors in norepinephrine equivalence.	From admission to the ICU through discharge from the ICU, up to 25 days.

Collaborators and Investigators

• Sponsor: Saint Francis Care
• Investigators: Principal Investigator: David Shapiro, MD, Saint Francis Hospital and Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): September 14, 2018
• Primary Completion (Actual): February 22, 2021
• Study Completion (Actual): February 22, 2021

Study Registration Dates

• First Submitted: June 18, 2018
• First Submitted That Met QC Criteria: July 9, 2018
• First Posted (Actual): July 19, 2018

Study Record Updates

• Last Update Posted (Actual): September 28, 2022
• Last Update Submitted That Met QC Criteria: September 9, 2022
• Last Verified: September 1, 2022

More Information

Terms related to this study

• Keywords: Septic Shock; Sepsis; Vitamin C; Thiamine
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Sepsis; Toxemia; Shock, Septic; Shock; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Protective Agents; Micronutrients; Antioxidants; Vitamin B Complex; Vitamins; Ascorbic Acid; Thiamine
• Other Study ID Numbers: SF-18-42

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No