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Thiamine for Diabetic Ketoacidosis

Phase 2

Recruiting

Led By Michael Donnino, MD

Research Sponsored by Beth Israel Deaconess Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up between 72 and 96 hours after enrollment or prior to discharge (whichever comes first)

Awards & highlights

Study Summary

This trial will test if giving thiamine to patients with diabetic ketoacidosis will help resolve their acidosis quicker. The trial will also see if thiamine improves cellular oxygen consumption, shortens ICU and hospital stay, or decreases hospital resource utilization.

Who is the study for?

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.Check my eligibility

What is being tested?

The 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.See study design

What are the potential side effects?

Thiamine generally has few side effects when used as directed; however, some individuals may experience allergic reactions or irritation at the injection site. Since this trial involves sick hospitalized patients, monitoring for any adverse effects will be thorough.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ between 72 and 96 hours after enrollment or prior to discharge (whichever comes first)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~between 72 and 96 hours after enrollment or prior to discharge (whichever comes first)

This trial's timeline: 3 weeks for screening, Varies for treatment, and between 72 and 96 hours after enrollment or prior to discharge (whichever comes first) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

plasma bicarbonate levels

Secondary outcome measures

ICU length of stay

anion gap

hospital length of stay

+3 more

Other outcome measures

C-peptide levels

Cognitive function: Brief Visual Spatial Memory Test

Cognitive function: Hopkins Verbal Learning Test

+6 more

Trial Design

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

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH

2,359 Previous Clinical Trials

4,315,395 Total Patients Enrolled

1 Trials studying Diabetic Ketoacidosis

Beth Israel Deaconess Medical CenterLead Sponsor

837 Previous Clinical Trials

13,010,172 Total Patients Enrolled

Michael Donnino, MDPrincipal Investigator - Beth Israel Deaconess Medical Center

Associated Physicians of Hmfp@Bidmc, Beth Israel Deaconess Medical Center, Cambridge Hospital, The, St. Luke's Hospital of New Bedford

Indiana University School Of Medicine (Medical School)

Henry Ford Hospital (Residency)

6 Previous Clinical Trials

512 Total Patients Enrolled

Media Library

200mg IV thiamine in 50mL 0.9% saline Clinical Trial Eligibility Overview. Trial Name: NCT03717896 — Phase 2

Diabetic Ketoacidosis Research Study Groups: Thiamine, Placebo

Diabetic Ketoacidosis Clinical Trial 2023: 200mg IV thiamine in 50mL 0.9% saline Highlights & Side Effects. Trial Name: NCT03717896 — Phase 2

200mg IV thiamine in 50mL 0.9% saline 2023 Treatment Timeline for Medical Study. Trial Name: NCT03717896 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has the administration officially sanctioned 200mg IV thiamine in 50mL 0.9% saline?

"Our internal assessment of 200mg IV thiamine in 50mL 0.9% saline gave it a score of 2 due to the Phase 2 trial status, suggesting that there is some evidence regarding safety but no data on efficacy."

Answered by AI

What is the greatest amount of individuals involved in this clinical trial?

"Correct. Per the information displayed on clinicaltrials.gov, this medical study is currently enrolling patients; it was first posted on November 21st 2018 and its last update occurred on December 7th 2021 with a goal of recruiting 100 individuals from 1 location."

Answered by AI

What clinical conditions can be treated with 200mg IV thiamine in 50mL 0.9% saline?

"200mg IV thiamine in 50mL 0.9% saline is the standard dose for treating vitamin deficiencies, as well as conditions such as anorexia, iron-deficiency anemia, and general nutrientional supplementation."

Answered by AI

Has there been any prior experimentation involving 200mg intravenous thiamine in a 50mL 0.9% saline solution?

"Presently, there are 6 ongoing trials to evaluate the effectiveness of 200mg IV thiamine in 50mL 0.9% saline. One of these tests is in its third stage and based out of Boston, Massachusetts; however, 10 different locations have been enlisted for this research initiative."

Answered by AI

Are there any vacancies left in this experiment for participants?

"According to the clinicaltrials.gov information, this investigation is actively recruiting participants. The study was initially announced on November 21st 2018 and recently modified on December 7th 2021."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Thiamine as Adjunctive Therapy for Diabetic Ketoacidosis

Michael Donnino 2018. "Thiamine as Adjunctive Therapy for Diabetic Ketoacidosis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03717896.