Vitamin C & Thiamine to Treat Sepsis and Septic Shock

Trinity Health Of New England120 enrolled

Overview

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

120

Conditions

Sepsis Septic Shock

Interventions

Vitamin CDRUG

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).

Vitamin B1DRUG

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).

Eligibility

Sex: ALLMin age: 18 YearsMax age: 90 Years

Medical Language ↔ Plain English

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

Locations (1)

Saint Francis Hospital and Medical Center

Hartford, Connecticut, United States

Outcomes

Primary Outcomes

Mortality Rates

All-cause mortality from time of enrollment/treatment to 30 days post hospital discharge (up to 87 days)

Time frame: From time of treatment to 30 days post hospital discharge, up to 87 days.

Secondary Outcomes

Hospital Length of Stay

Total number of days patient is admitted to the hospital

Time frame: 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

Time frame: 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

Time frame: 30 days after hospital discharge

Ventilator Days

Number of days patient required ventilator

Time frame: 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.

Time frame: From admission to the ICU through discharge from the ICU, up to 25 days.

Data from ClinicalTrials.gov

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