Metformin in severe traumatic brain injury

A randomized controlled trial on the efficacy and safety of Metformin in severe traumatic brain injury

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20180803040681N1

Enrollment

Registered

2018-10-20

Start date

2016-04-03

Completion date

Unknown

Last updated

2019-01-14

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

Conditions

Severe Traumatic Brain Injury. Diffuse traumatic brain injury

Interventions

Intervention 1: Intervention group: 1g metformin two times a day at twelve-hour intervals for five consecutive days through a nasogastric tube and usual management at the discretion of the critical ca

Eligibility

Sex/Gender

All

Age

18 Years to 65 Years

Inclusion criteria

Inclusion criteria: a definite diagnosis of head trauma GCS score of 8 or less patients on mechanical ventilator written informed consent signed by patient’s legal guardian

Exclusion criteria

Exclusion criteria: time of admission to ICU of more than 48 hours Nil Per Os (NPO) status on admission day diabetes previous treatment with metformin or any other biguanide medication blood glucose level of =150mg/dL or =70mg/dL simultaneous participation in another clinical trial serum creatinine level of 1.5mg/dL or more serum lactate level of 2.5mmol/L or more arterial pH of less than 7.25 serum bicarbonate of 13mEq/L or less moderate to severe renal impairment (estimated glomerular filtration rate (eGFR) of below 45mL/min/1.73m2) cirrhosis acute liver failure

Design outcomes

Primary

Measure	Time frame
The 5-day post-trauma serum concentration profile of S100B to evaluate the prognosis of study groups. Timepoint: On admission and at 24h, 48h, 72h and 120h post-allocation. Method of measurement: ELISA kit.	—

Secondary

Measure	Time frame
5-day post-trauma serum concentration profile of GFAP. Timepoint: On admission and at 24h, 48h, 72h and 120h. Method of measurement: ELISA kits.;5-day post-trauma serum concentration profile of NLR. Timepoint: On admission and at 24h, 48h, 72h and 120h. Method of measurement: ELISA kits.;Pharmacokinetic parameters. Timepoint: 0.5h, 1h, 2h, 4h, 8h and 12h post-intervention. Method of measurement: Ultra High Performance Liquid Chromatography coupled to mass spectrometry.;Safety. Timepoint: Throughout hospital stay. Method of measurement: Monitoring; Lab data.	—

Measure

Time frame

5-day post-trauma serum concentration profile of GFAP. Timepoint: On admission and at 24h, 48h, 72h and 120h. Method of measurement: ELISA kits.;5-day post-trauma serum concentration profile of NLR. Timepoint: On admission and at 24h, 48h, 72h and 120h. Method of measurement: ELISA kits.;Pharmacokinetic parameters. Timepoint: 0.5h, 1h, 2h, 4h, 8h and 12h post-intervention. Method of measurement: Ultra High Performance Liquid Chromatography coupled to mass spectrometry.;Safety. Timepoint: Throughout hospital stay. Method of measurement: Monitoring; Lab data.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactMojtaba Mojtahedzadeh

Tehran University of Medical Sciences

Mojtahed@tums.ac.ir+98 21 6646 1178

Outcome results

None listed

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