Thiamine for Diabetic Ketoacidosis

Recruiting in Palo Alto (17 mi)

Overseen byMichael Donnino, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Beth Israel Deaconess Medical Center

Prior Safety Data

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?

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.

Research Team

Michael Donnino, MD

Principal Investigator

Beth Israel Deaconess Medical Center

Eligibility Criteria

This trial is for hospital patients with diabetic ketoacidosis, characterized by a blood pH≤7.24, anion gap >12 mEq/L, bicarbonate ≤15 mEq/L, and high urine or serum ketones. They must be enrolled within 6 hours of presentation but can't join if they take daily thiamine supplements over 6mg, have certain severe conditions like liver dysfunction or allergies to thiamine.

Inclusion Criteria

Your bicarbonate level is less than or equal to 15 milliequivalents per liter.

Your blood pH level is lower than 7.24.

Your anion gap level is higher than 12 mEq/L.

See 2 more

Exclusion Criteria

You have an allergy to thiamine.

I do not have severe acidosis due to conditions like seizures or liver dysfunction.

You have another medical reason to take thiamine, like being treated for alcoholism.

See 4 more

Treatment Details

Interventions

Thiamine (Vitamin)

Trial OverviewThe study tests whether giving IV thiamine helps resolve acidosis faster in diabetic ketoacidosis patients compared to a placebo. It's randomized and double-blind; neither doctors nor participants know who gets real treatment versus placebo. The impact on oxygen use, ICU/hospital stay length, and resource use is also studied.

Participant Groups

2Treatment groups

Experimental Treatment

Placebo Group

Group I: ThiamineExperimental Treatment1 Intervention

200mg IV thiamine in 50mL 0.9% saline twice daily for 2 days

Group II: PlaceboPlacebo Group1 Intervention

100mL 0.9% saline twice daily for two days