NCT03717896

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Nov 2018

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 22, 2018

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 24, 2018

Completed
28 days until next milestone

Study Start

First participant enrolled

November 21, 2018

Completed
5.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2024

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2024

Completed
Last Updated

October 31, 2024

Status Verified

October 1, 2024

Enrollment Period

5.9 years

First QC Date

October 22, 2018

Last Update Submit

October 29, 2024

Conditions

Diabetic Ketoacidosis

Keywords

diabetic ketoacidosisDKAthiamineacidosisoxygen consumptionlactate

Outcome Measures

Primary Outcomes (1)

  • plasma bicarbonate levels

    Our primary outcome is change in bicarbonate over the 24 hours following enrollment with measurements at 0, 6, 12, 18, 24 hours using a linear-effects model

    24 hours

Secondary Outcomes (6)

  • anion gap

    24 hours

  • lactate

    24 hours

  • oxygen consumption by circulating mononuclear cells

    24 hours

  • ICU length of stay

    24 hours

  • hospital length of stay

    24 hours

  • +1 more secondary outcomes

Other Outcomes (9)

  • SOFA score (sequential organ failure assessement score)

    24 hours

  • C-peptide levels

    0 and 72 hours

  • Duration of insulin therapy

    First 7 days after enrollment

  • +6 more other outcomes

Study Arms (2)

Thiamine

EXPERIMENTAL

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

Drug: 200mg IV thiamine in 50mL 0.9% saline

Placebo

PLACEBO COMPARATOR

100mL 0.9% saline twice daily for two days

Drug: Placebo

Interventions

200mg IV thiamine in 50mL 0.9% salineDRUG

Thiamine 200mg IV every 12 hours for 2 days

Also known as: Vitamin B1
Thiamine
PlaceboDRUG

50mL 0.9% saline

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Related Publications (1)

  • Vine J, Mehta S, Balaji L, Berg KM, Berlin N, Liu X, Ngo L, Shea M, Moskowitz A, Donnino MW, Grossestreuer AV. Thiamine as adjunctive therapy for diabetic ketoacidosis (DKAT) trial protocol and statistical analysis plan: a prospective, single-centre, double-blind, randomised, placebo-controlled clinical trial in the USA. BMJ Open. 2024 Feb 29;14(2):e077586. doi: 10.1136/bmjopen-2023-077586.

    PMID: 38423765DERIVED

MeSH Terms

Conditions

Diabetic KetoacidosisAcidosis

Interventions

ThiamineSodium Chloride

Condition Hierarchy (Ancestors)

KetosisAcid-Base ImbalanceMetabolic DiseasesNutritional and Metabolic DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System Diseases

Intervention Hierarchy (Ancestors)

ThiazolesSulfur CompoundsOrganic ChemicalsAzolesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPyrimidinesChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Officials

  • Michael Donnino, MD

    Beth Israel Deaconess Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Medicine and Emergency Medicine

Study Record Dates

First Submitted

October 22, 2018

First Posted

October 24, 2018

Study Start

November 21, 2018

Primary Completion

September 30, 2024

Study Completion

October 1, 2024

Last Updated

October 31, 2024

Record last verified: 2024-10

Data Sharing

IPD Sharing
Will not share

Locations

US(1)