Thiamine as Adjunctive Therapy for Diabetic Ketoacidosis

• Status: Recruiting
• Trial end date: 2023-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Beth Israel Deaconess Medical Center
• Collaborator: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Treatments: Thiamine

Criteria

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., alcoholic)

• Research-protected populations (pregnant women, prisoners, the intellectually disabled)

• Patient enrolled previously in same study

• Code status of Do Not Resuscitate/Do Not Intubate (DNR/DNI) or Comfort Measures Only (CMO)