Vitamin C & Thiamine to Treat Sepsis and Septic Shock

Trinity Health Of New England

Status and phase: Completed; Phase 2

Conditions: Septic Shock; Sepsis

Treatments: Drug: Vitamin C; Drug: Vitamin B1

Study type: Interventional

Funder types: Other

Identifiers

NCT03592277

SF-18-42

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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120 participants in 2 patient groups

TREATMENT with Vitamins C and B1

Experimental group

Description:

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:

Drug: Vitamin B1

Drug: Vitamin C

PLACEBO with saline only

No Intervention group

Description:

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.