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THIAMINE SUPPLEMENTATION IN DIABETIC KETOACIDOSIS

THIAMINE SUPPLEMENTATION IN THE MANAGEMENT OF DIABETIC KETOACIDOSIS: AN OPEN LABEL RANDOMIZED CONTROLLED TRIAL

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2023/05/053199
Enrollment
120
Registered
2023-05-29
Start date
Unknown
Completion date
Unknown
Last updated
2024-09-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: E111- Type 2 diabetes mellitus with ketoacidosis

Interventions

Intervention1: INTRAVENOUS THIAMINE WITH STANDARD DKA TREATMENT: intravenous thiamine 200 MG in 100 mL Normal Saline over 30 minutes once a day for 3 days in addition to standard DKA management Cont

Sponsors

Academic clinical trail at govt hospital
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Adult patients aged 18 years or older giving written informed consent. Patients admitted to the hospital with a diagnosis of diabetic ketoacidosis. {Defined as Clinical Signs and Symptoms with Hyperglycemia ?250 mg/dL with metabolic acidosis with high anion gap [S. Bicarbonate =15 mEq/L, anion gap ?12 mEq/L, Blood PH ?7.3] with Urine ketones (qualitative) Positive}1

Exclusion criteria

Exclusion criteria: Patients with history of alcohol abuse or dependence . Patients who are pregnant or breastfeeding . Patients with diagnosis of shock and acute or chronic kidney disease. Repeat episode of DKA in previously enrolled patient.

Design outcomes

Primary

MeasureTime frame
Difference in time to resolution between the intervention group and active control groupTimepoint: Baseline, 3 days or earlier if DKA resolves

Secondary

MeasureTime frame
Difference in morbidity and mortalityTimepoint: Baseline, 3 days, time of discharge

Countries

India

Contacts

Public ContactALISHA KHAN

UCMS and GTB Hospital

shivanarang@gmail.com9899838807

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026