Protocol summary

Summary
This study conducted for the evaluation of hypertonic saline osmotic therapy and added with furosemide in traumatic brain injury’s patients. One group of 30 of the patients will be received 100 ml of hypertonic saline (NaCl 5%) as a loading dose, and then 20ml/h of infusion. Another group of 30 will be received 100 ml of hypertonic saline (NaCl 5%) and 40mg furosemide as a loading dose, and then 20ml/h of NaCl 5% and 0.05mg/kg/ h of furosemide as a 24 h infusion. Evaluation of serum sodium and its osmolarity, changes of S100B and NSE biomarker will be considered as management indicators. Hormonal alteration (Thyroid and Prolactin) will be concidered as an evaluation of severity of the trauma and the effect of osmotic therapy to reduce hormonal alteration and prolonged function of the patients.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201509283014N10
Registration date: 2016-07-13, 1395/04/23
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2016-07-13, 1395/04/23
Registrant information
Name
Shahram Ala
Name of organization / entity
Mazandaran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 15 1354 3083
Email address
sala@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor of research, Mazandaran university of medical sciences
Expected recruitment start date
2016-04-18, 1395/01/30
Expected recruitment end date
2016-09-20, 1395/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of effect of furosemide add on to hypertonic slain on neurohormonal factors in Traumatic brain injury,A randomized single blind clinical trial
Public title
Evaluation of effect of furosemide add on to hypertonic slain on neurohormonal factors in Traumatic brain injury
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: All of patients with 18-90 years old with closed head trauma ; associated with brain edema confirmed with CT scan ; Hemodynamically stable before management; GCS<14; Patients with CV line ; admission with in 24 hours of initial insult
Age
From 18 years old to 90 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 60
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Mazandaran University of medical sciences
Street address
Vice chancellor of research,moalem sq.
City
Sari
Postal code
Approval date
2015-11-28, 1394/09/07
Ethics committee reference number
IR.MAZUMS.REC.94-1924

Health conditions studied

1

Description of health condition studied
brain injury
ICD-10 code
S06.0-S06-
ICD-10 code description
Concussion,Traumatic cerebral oedema, Diffuse brain injury, Focal brain injury, Epidural haemorrhage,Traumatic subdural haemorrhage,Traumatic subarachnoid haemorrhage, Intracranial injury with prolonged coma, Other intracranial injuries, Intracranial inju

Primary outcomes

1

Description
Bloood Na
Timepoint
1,2.3.4 days
Method of measurement
Serum concentraion

2

Description
Blood osmolality
Timepoint
1,2,3,4 days
Method of measurement
With calculation of ions affect the osmolarity

Secondary outcomes

1

Description
ُُS100B
Timepoint
1,2,3,4 days
Method of measurement
Kit (spectrophotometery)

2

Description
NSE
Timepoint
1,3,5
Method of measurement
Kit (spectrophotometery)

Intervention groups

1

Description
One groups receives at a dose of 20ml / h and furosemide for 0.05mg / kg / h for 72 hours .
Category
Treatment - Drugs

2

Description
Control group receives for 72 hours at a dose of 20ml /h saline hyperton
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Emam khomeini hospital and educational center, Sari
Full name of responsible person
Dr. Shahram Ala
Street address
City
Sari

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences, Vice chancellor for research
Full name of responsible person
Dr Ahmadali Enayati
Street address
Mazandaran University of Medical Sciences, Vice chancellor for research, Moallem square, Sari, Mazandaran, Iran Sari
City
Sari
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Mazandaran University of Medical Sciences, Vice chancellor for research
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Dr.Marziyeh Jafari
Position
Clinical pharmacy student
Other areas of specialty/work
Street address
Payambar azam university complex, Mazandaran University of Medical Sciences, Faculty of pharmacy,18
City
Sari
Postal code
Phone
00
Fax
Email
drmjafari1985@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Mazandaran university of medical sciences
Full name of responsible person
Dr. Shahram Ala
Position
Mazandaran University of Medical Sciences
Other areas of specialty/work
Street address
Payambar azam university complex, Mazandaran University of Medical Sciences, Faculty of pharmacy, Km 18 Khazar abad road, Sari, Mazandaran, Iran
City
Sari
Postal code
Phone
00
Fax
Email
sala@mazums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Dr.Marziyeh Jafari
Position
Clinical pharmacy student
Other areas of specialty/work
Street address
Payambar azam university complex, Mazandaran University of Medical Sciences, Faculty of pharmacy, Km 18 Khazar abad road, Sari, Mazandaran, Iran
City
Sari
Postal code
Phone
00
Fax
Email
drmjafari1985@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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