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Completed

NCT Number: NCT03592277

Vitamin C & Thiamine to Treat Sepsis and Septic Shock

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.

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Key information

Conditions

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

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Saint Francis Hospital and Medical Center

Hartford, Connecticut, 06105, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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).

Other names: Ascorbic Acid

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).

Other names: Thiamine

Primary outcomes

  1. 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

  1. Hospital Length of Stay

    Time frame: From admission to the hospital through hospital discharge, up to 57 days.

    Total number of days patient is admitted to the hospital

  2. Intensive Care Unit Length of Stay

    Time frame: From time of admission to the ICU through discharge from the ICU, up to 25 days

    Total number of days patient is admitted to the ICU

  3. Readmission Rate

    Time frame: 30 days after hospital discharge

    Readmission to the hospital within 30 days after discharge

  4. Ventilator Days

    Time frame: From admission to the ICU through discharge from the ICU, up to 25 days.

    Number of days patient required ventilator

  5. Hours on Vasopressors

    Time frame: From admission to the ICU through discharge from the ICU, up to 25 days.

    Number of hours patient required vasopressors in norepinephrine equivalence.

Sponsors and collaborators

Lead sponsor

Trinity Health Of New England

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Jul 19, 2018
Registry last updated
Sep 28, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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