Metformin in severe traumatic brain injury
Phase 2
- Conditions
- Severe Traumatic Brain Injury.Diffuse traumatic brain injury
- Registration Number
- IRCT20180803040681N1
- Lead Sponsor
- Tabriz University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 30
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
time of admission to ICU of more than 48 hours
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
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.