CompletedPhase 2

Vitamin C & Thiamine to Treat Sepsis and Septic Shock

United States120 participantsStarted 2018-09-14

Plain-language 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.

Who can participate

Age range

18 Years – 90 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Mortality Rates

Timeframe: From time of treatment to 30 days post hospital discharge, up to 87 days.

Trial details

NCT IDNCT03592277

SponsorTrinity Health Of New England

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2021-02-22

Results submitted2022-03-22

View on ClinicalTrials.gov More Sepsis trials