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Vitamin C & Thiamine to Treat Sepsis and Septic Shock

Primary Purpose

Sepsis, Septic Shock

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Vitamin C
Vitamin B1
Sponsored by
Trinity Health Of New England
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Sepsis focused on measuring Sepsis, Septic Shock, Vitamin C, Thiamine

Eligibility Criteria

18 Years - 90 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Saint Francis Hospital and Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

TREATMENT with Vitamins C and B1

PLACEBO with saline only

Arm 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).

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.

Outcomes

Primary Outcome Measures

Mortality Rates
All-cause mortality from time of enrollment/treatment to 30 days post hospital discharge (up to 87 days)

Secondary Outcome Measures

Hospital Length of Stay
Total number of days patient is admitted to the hospital
Intensive Care Unit Length of Stay
Total number of days patient is admitted to the ICU
Readmission Rate
Readmission to the hospital within 30 days after discharge
Ventilator Days
Number of days patient required ventilator
Hours on Vasopressors
Number of hours patient required vasopressors in norepinephrine equivalence.

Full Information

First Posted
June 18, 2018
Last Updated
September 9, 2022
Sponsor
Trinity Health Of New England
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1. Study Identification

Unique Protocol Identification Number
NCT03592277
Brief Title
Vitamin C & Thiamine to Treat Sepsis and Septic Shock
Official Title
Vitamins B1 and C to Improve Outcomes in Patients With Severe Sepsis
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
September 14, 2018 (Actual)
Primary Completion Date
February 22, 2021 (Actual)
Study Completion Date
February 22, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Trinity Health Of New England

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sepsis, Septic Shock
Keywords
Sepsis, Septic Shock, Vitamin C, Thiamine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
All parties involved, except for pharmacy personnel will be blinded.
Allocation
Randomized
Enrollment
120 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TREATMENT with Vitamins C and B1
Arm Type
Experimental
Arm 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).
Arm Title
PLACEBO with saline only
Arm Type
No Intervention
Arm 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.
Intervention Type
Drug
Intervention Name(s)
Vitamin C
Other Intervention Name(s)
Ascorbic Acid
Intervention Description
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).
Intervention Type
Drug
Intervention Name(s)
Vitamin B1
Other Intervention Name(s)
Thiamine
Intervention Description
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).
Primary Outcome Measure Information:
Title
Mortality Rates
Description
All-cause mortality from time of enrollment/treatment to 30 days post hospital discharge (up to 87 days)
Time Frame
From time of treatment to 30 days post hospital discharge, up to 87 days.
Secondary Outcome Measure Information:
Title
Hospital Length of Stay
Description
Total number of days patient is admitted to the hospital
Time Frame
From admission to the hospital through hospital discharge, up to 57 days.
Title
Intensive Care Unit Length of Stay
Description
Total number of days patient is admitted to the ICU
Time Frame
From time of admission to the ICU through discharge from the ICU, up to 25 days
Title
Readmission Rate
Description
Readmission to the hospital within 30 days after discharge
Time Frame
30 days after hospital discharge
Title
Ventilator Days
Description
Number of days patient required ventilator
Time Frame
From admission to the ICU through discharge from the ICU, up to 25 days.
Title
Hours on Vasopressors
Description
Number of hours patient required vasopressors in norepinephrine equivalence.
Time Frame
From admission to the ICU through discharge from the ICU, up to 25 days.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Shapiro, MD
Organizational Affiliation
Saint Francis Hospital and Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Saint Francis Hospital and Medical Center
City
Hartford
State/Province
Connecticut
ZIP/Postal Code
06105
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Vitamin C & Thiamine to Treat Sepsis and Septic Shock

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