Vitamin C & Thiamine to Treat Sepsis and Septic Shock

Phase 2

Completed

Brief Summary: 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.

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.

Recruitment & Eligibility

Inclusion Criteria

Not provided

Exclusion Criteria

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

Arm && Interventions

Group	Intervention	Description
TREATMENT with Vitamins C and B1	Vitamin C	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).
TREATMENT with Vitamins C and B1	Vitamin 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).

Primary Outcome Measures

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

Secondary Outcome Measures

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