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IRCT20180803040681N1 IRCT 2018-10-20 Tabriz University of Medical Sciences Metformin in severe traumatic brain injury A randomized controlled trial on the efficacy and safety of Metformin in severe traumatic brain injury 2016-04-03 anticipated 30 Complete https://irct.ir/trial/34422 interventional Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization sequence was created using R-3.2.3 statistical software. Eligible patients were randomly assigned to study groups in a 1:1 ratio using random block sizes of 2 and 4, Blinding description: Patients are not mentally oriented as their GCS score is 8 or less. 2-3 Severe Traumatic Brain Injury. 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 care team. Intervention 2: Control group: usual management at the discretion of the critical care team. Yes - There is a plan to make this available What will be shared: All collected deidentified IPD When: Starting 6 months after publication To whom: People working in academic institutions People working in businesses Conditions: Without limitations in case of citing the study article Where to obtain: Via E-mail: a-taheri@student.tums.ac.ir How to obtain: Stating the objective of requesting the data Comments:
public Mojtaba Mojtahedzadeh
Poursina Ave., Qods Ave., Tehran, Iran
Tehran Iran (Islamic Republic of) 1417614411 +98 21 6646 1178 Mojtahed@tums.ac.ir Tehran University of Medical Sciences scientific Ali Taheri
Poursina Ave., Qods Ave., Tehran, Iran
Tehran Iran (Islamic Republic of) 1417614411 +98 21 8163 3047 a-taheri@student.tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) 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 18 years 65 years Both 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 S06.2 Diffuse traumatic brain injury Treatment - Drugs Treatment - Drugs 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 care team Control group: usual management at the discretion of the critical care team 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. 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. Tabriz University of Medical Sciences Approved 2016-04-12 Ethics committee of Tehran University of Medical Sciences Poursina Ave., Qods Ave., Tehran, Iran Tehran Tehran Iran (Islamic Republic of)