Vitamin C & Thiamine to Treat Sepsis and Septic Shock

NCT03592277 | Completed Phase 2 Results FDA Drug

• 1 other identifier: SF-18-42
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Sepsis; Septic Shock

Keywords

Sepsis; Septic Shock; Vitamin C; Thiamine

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Hospital Length of Stay

  From admission to the hospital through hospital discharge, up to 57 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

• 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.

Study Arms (2)

TREATMENT with Vitamins C and B1

EXPERIMENTAL

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; Drug: Vitamin B1

PLACEBO with saline only

NO INTERVENTION

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.

Interventions

Vitamin C DRUG

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).

Also known as: Ascorbic Acid

TREATMENT with Vitamins C and B1

Vitamin B1 DRUG

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).

Also known as: Thiamine

TREATMENT with Vitamins C and B1

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Trinity Health Of New England: lead

Study Sites (1)

Saint Francis Hospital and Medical Center

Hartford, Connecticut, 06105, United States

Location

MeSH Terms

Conditions

Sepsis; Shock, Septic

Interventions

Ascorbic Acid; Thiamine

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Intervention Hierarchy (Ancestors)

Sugar Acids; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Hydroxy Acids; Carbohydrates; Thiazoles; Sulfur Compounds; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Pyrimidines

Results Point of Contact

• Title: David Shapiro, MD, MHCM, FACS, FCCM CMO of Saint Francis Hospital and Medical Center
• Organization: Saint Francis Hospital and Medical Center

dshapiro@trinityhealthofne.org

860-833-5673

Study Officials

• David Shapiro, MD

  Saint Francis Hospital and Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: All parties involved, except for pharmacy personnel will be blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 18, 2018
• First Posted: July 19, 2018
• Study Start: September 14, 2018
• Primary Completion: February 22, 2021
• Study Completion: February 22, 2021
• Last Updated: September 28, 2022
• Results First Posted: September 28, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)