Vitamins B1 and C to Improve Outcomes in Patients With Severe Sepsis
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Enrollment
- 120
- Locations
- 1
- Primary Endpoint
- Mortality Rates
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description
All parties involved, except for pharmacy personnel will be blinded.
Eligibility Criteria
- Ages
- 18 Years to 90 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
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).
Intervention: Vitamin C (Drug)
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).
Intervention: Vitamin B1 (Drug)
Outcomes
Primary Outcomes
Mortality Rates
Time Frame: 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 Outcomes
- Hospital Length of Stay(From admission to the hospital through hospital discharge, up to 57 days.)
- Ventilator Days(From admission to the ICU through discharge from the ICU, up to 25 days.)
- Hours on Vasopressors(From admission to the ICU through discharge from the ICU, up to 25 days.)
- Intensive Care Unit Length of Stay(From time of admission to the ICU through discharge from the ICU, up to 25 days)
- Readmission Rate(30 days after hospital discharge)