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

Protocol summary

Study aim
To investigate safety and efficacy of Metformin in severe traumatic brain injury (TBI) patients
Design
single-center, single-blind, parallel-group, randomized controlled trial
Settings and conduct
The study took place in the intensive care unit (ICU) of the Sina Hospital in Tehran, Iran in severe TBI patients. Blood sampling from the eligible patients for the measurement of efficacy biomarkers was performed on admission and at 24h, 48h, 72h and 120h post-allocation in all study patients and for pharmacokinetic parameters samples were obtained at 0.5h, 1h, 2h, 4h, 8h and 12h post-intervention in the intervention group. Based on the unconsciousness of the patients (GCS of 8 or less), the study was single blinded.
Participants/Inclusion and exclusion criteria
Main inclusion criteria: definite diagnosis of head trauma, GCS score of 8 or less, an age of 18 to 65 years, and written signed informed consent Main exclusion criteria: time of admission to ICU of more than 48 hours, lab data out of the ranges in protocol, NPO status, diabetes, previous treatment with metformin
Intervention groups
Intervention: 1g metformin b.i.d at 12h intervals for 5 consecutive days and usual management Control: usual management of severe TBI
Main outcome variables
Primary: 5-day post-trauma serum concentration profile of S100B Secondary: 5-day post-trauma serum concentration profile of GFAP and NLR; Safety; Pharmacokinetic parameters

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20180803040681N1
Registration date: 2018-10-20, 1397/07/28
Registration timing: retrospective

Last update: 2018-10-20, 1397/07/28
Update count: 0
Registration date
2018-10-20, 1397/07/28
Registrant information
Name
Ali Taheri
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 8163 3047
Email address
a-taheri@student.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2016-04-03, 1395/01/15
Expected recruitment end date
2018-02-20, 1396/12/01
Actual recruitment start date
2016-05-01, 1395/02/12
Actual recruitment end date
2018-06-01, 1397/03/11
Trial completion date
2018-07-06, 1397/04/15
Scientific title
A randomized controlled trial on the efficacy and safety of Metformin in severe traumatic brain injury
Public title
Metformin in severe traumatic brain injury
Purpose
Treatment
Inclusion/Exclusion 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:
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
Age
From 18 years old to 65 years old
Gender
Both
Phase
2-3
Groups that have been masked
  • Participant
Sample size
Target sample size: 30
Actual sample size reached: 30
Randomization (investigator's opinion)
Randomized
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 (investigator's opinion)
Single blinded
Blinding description
Patients are not mentally oriented as their GCS score is 8 or less.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences
Street address
Poursina Ave., Qods Ave., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1417614411
Approval date
2016-04-12, 1395/01/24
Ethics committee reference number
IR.TUMS.REC.1395.2380

Health conditions studied

1

Description of health condition studied
Severe Traumatic Brain Injury
ICD-10 code
S06.2
ICD-10 code description
Diffuse traumatic brain injury

Primary outcomes

1

Description
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 outcomes

1

Description
5-day post-trauma serum concentration profile of GFAP
Timepoint
On admission and at 24h, 48h, 72h and 120h
Method of measurement
ELISA kits

2

Description
5-day post-trauma serum concentration profile of NLR
Timepoint
On admission and at 24h, 48h, 72h and 120h
Method of measurement
ELISA kits

3

Description
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

4

Description
Safety
Timepoint
Throughout hospital stay
Method of measurement
Monitoring; Lab data

Intervention groups

1

Description
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
Category
Treatment - Drugs

2

Description
Control group: usual management at the discretion of the critical care team
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
intensive care unit (ICU) of the Sina University Teaching Hospital
Full name of responsible person
Mojtaba Mojtahedzadeh
Street address
Hassanabad Sq., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1417614411
Phone
+98 21 6646 1178
Email
a-taheri@student.tums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Ramin Heshmat
Street address
Shariati hospital, Kargar Ave., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1411713137
Phone
+98 21 8863 1298
Email
rheshmat@tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic

Person responsible for general inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Mojtaba Mojtahedzadeh
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
Emergency Medicine
Street address
Poursina Ave., Qods Ave., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1417614411
Phone
+98 21 6646 1178
Email
Mojtahed@tums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Ali Taheri
Position
Student
Latest degree
Medical doctor
Other areas of specialty/work
Medical Pharmacy
Street address
Poursina Ave., Qods Ave., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1417614411
Phone
+98 21 8163 3047
Fax
Email
a-taheri@student.tums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Ali Taheri
Position
Student
Latest degree
Medical doctor
Other areas of specialty/work
Medical Pharmacy
Street address
Poursina Ave., Qods Ave., Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1417614411
Phone
+98 21 8163 3047
Fax
Email
a-taheri@student.tums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
All collected deidentified IPD
When the data will become available and for how long
Starting 6 months after publication
To whom data/document is available
People working in academic institutions People working in businesses
Under which criteria data/document could be used
Without limitations in case of citing the study article
From where data/document is obtainable
Via E-mail: a-taheri@student.tums.ac.ir
What processes are involved for a request to access data/document
Stating the objective of requesting the data
Comments
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