Thiamine as Adjunctive Therapy for Diabetic Ketoacidosis (NCT03717896) | Clinical Trial Compass
CompletedPhase 2
Thiamine as Adjunctive Therapy for Diabetic Ketoacidosis
United States102 participantsStarted 2018-11-21
Plain-language summary
This is a randomized, double-blind, placebo-controlled trial to determine if administration of intravenous thiamine will lead to quicker resolution of acidosis in patients admitted to the hospital with diabetic ketoacidosis. The investigators will secondarily investigate whether thiamine improves cellular oxygen consumption, shortens intensive care unit (ICU) and hospital stay or decreases hospital resource utilization.
Who can participate
Age range
18 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:
* Bicarbonate ≤15 mEq/L
* Anion gap \> 12 mEq/L
* Blood pH≤ 7.24 (if already obtained by clinical team)
* Urine ketones (qualitative) or serum ketones (β-hydroxybutyric acid) \> 3 mmol/L
* Enrollment within 6 hours of presentation
Exclusion Criteria:
* Current thiamine supplementation ≥ 6 milligrams per day (i.e., more than a multivitamin)
* Competing causes of severe acidosis including seizure, carbon monoxide poisoning, cyanide toxicity, cardiac arrest, liver dysfunction (specifically defined as known cirrhosis)
* Known allergy to thiamine
* Competing indication for thiamine administration as judged by the clinical team (e.g., significant alcohol use)
* Research-protected populations (pregnant women and prisoners)
* Patient enrolled previously in same study
* Code status of Do Not Resuscitate/Do Not Intubate (DNR/DNI) or Comfort Measures Only (CMO)
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
1
Plasma Bicarbonate Levels
Timeframe: 6, 12, 18, and 24 hours after enrollment