Vitamin C & Thiamine to Treat Sepsis and Septic Shock

Sepsis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03592277
• Other study ID #: SF-18-42
• Status: Completed
• Phase: Phase 2
• Start date: September 14, 2018
• Est. completion date: February 22, 2021

Study information

• Verified date: September 2022
• Source: Saint Francis Care
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: February 22, 2021
• Est. primary completion date: February 22, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Sepsis
• Septic Shock
• Shock
• Shock, Septic
• Toxemia

Intervention

Drug:
• Vitamin C
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 B1
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).

Locations

Country	Name	City	State
United States	Saint Francis Hospital and Medical Center	Hartford	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Saint Francis Care

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	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
Secondary	Readmission Rate	Readmission to the hospital within 30 days after discharge	30 days after hospital discharge
Secondary	Ventilator Days	Number of days patient required ventilator	From admission to the ICU through discharge from the ICU, up to 25 days.
Secondary	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.