Vitamin C & Thiamine to Treat Sepsis and Septic Shock

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Sepsis, Septic Shock

Intervention / Treatment
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* Drug: Vitamin C
* Drug: Vitamin B1


Participation Criteria
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Eligibility Criteria
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Patients must meet all inclusion criteria: Between the ages of 18 and 90 years old Have severe sepsis or septic shock. Severe sepsis and septic shock will be defined by the Surviving Sepsis 2012 guidelines. Weight more than 30 kg Full code 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TREATMENT with Vitamins C and B1<br>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<br>* 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).<br>* Other names: Ascorbic Acid;Drug: Vitamin B1<br>* 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).<br>* Other names: Thiamine;|
| No Intervention: PLACEBO with saline only<br>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?
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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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Sepsis, Septic Shock, Vitamin C, Thiamine