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Study of Methyl Prednisolone preventive effects in Fat Embolism Syndrome on Patients with Fracture of Long Bones

Protocol summary

Summary
Study of preventive Effects of Methyl Prednisolone in Fat Embolism Syndrome on Patients with Fracture of Long Bones that will be done on 94 patients with closed fractures of tibia or femor during their admission in hospital.patients with skull,chest,lungs,pelvic,diaphragm,urogential injuries and... will be exclude. patients will be placed in two 47 patients category randomizely by block randomization. patients will be intravenousy injected by methylprednisolon or placebo(N/S)three times at the begining and then every 4 hours with the dosage of 10 mg/kg.All the patients will be examine at 0,12,24,72 hours after the admission and body temprature,heart rate,blood pressure, respiratory rate and Arterial blood gases will be mesured .outcomes we studies are based on lindeque criterias that includes respiratory parameters:1-pao2<60 mmhg 2-paco2>55 mmhg 3- respiratory rate>35 after good sedation 4-dyspnea,tachypnea..based on this criteria patients who has one or more of this parameters are diagnosed fat emboli syndrome

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2013101311898N6
Registration date: 2014-12-24, 1393/10/03
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2014-12-24, 1393/10/03
Registrant information
Name
Ahmadreza Mirbolouk
Name of organization / entity
Guilin University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 13 1322 2250
Email address
ah.mirbolouk@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
Guilan University of Medical Sciences
Expected recruitment start date
2014-12-03, 1393/09/12
Expected recruitment end date
2015-01-02, 1393/10/12
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study of Methyl Prednisolone preventive effects in Fat Embolism Syndrome on Patients with Fracture of Long Bones
Public title
ُStudy of Methyl Prednisolone effects on fat emboli in the patients with fractures
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Patiens with closed fractures of femor or tibia that refers to poursina hospital Exclusion criteria: patients with skull,chest,lungs,pelvic,diaphragm,urogential injuries and pathologic fracture,pregnant women, history of cardiac and lung disease or a history of corticosteroid treatment will not be included in
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 94
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Research and Technology Department of Guilan University of Medical Sciences
Street address
Next to Iranradiator Building, Gaz Square, Rasht
City
Rasht
Postal code
Approval date
2014-11-25, 1393/09/04
Ethics committee reference number
1930400402

Health conditions studied

1

Description of health condition studied
Fat Embolism
ICD-10 code
t79.1
ICD-10 code description
Fat embolism (traumatic)

Primary outcomes

1

Description
pco2>55mmhg
Timepoint
first visit,12h.24h,72h after admission
Method of measurement
mmhg, lab tests

2

Description
po2<60 mmhg
Timepoint
first visit,12h.24h,72h after admission
Method of measurement
mmhg, lab tests

3

Description
respiratory rate>35 per minute
Timepoint
first visit,12h.24h,72h after admission
Method of measurement
clinical examination

4

Description
dyspnea, Tachypnea
Timepoint
first visit,12h.24h,72h after admission
Method of measurement
clinical examination

Secondary outcomes

1

Description
Acidotic Arterial blood PH
Timepoint
first visit, 12h,24,72 h after admission
Method of measurement
Lab test(ABG)

Intervention groups

1

Description
intraveinously injection of Methyl prednisolone with the dosage of 10 mg/kg every 4 hours during 72 h of addmission
Category
Treatment - Drugs

2

Description
intraveinously injection of placebo(normal salin) with the dosage of 10 mg/kg every 4 hours during 72 h of addmission
Category
Placebo

Recruitment centers

1

Recruitment center
Name of recruitment center
Poursina hospital
Full name of responsible person
Street address
City
Rasht

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Research and Technology Department of Guilan University of Medical Sciences
Full name of responsible person
Abtin Heidarzadeh (Specialist)
Street address
Reaserch and Technology Building next to Iran Radiator Building, Gaz Square, Rasht
City
Rasht
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research and Technology Department of Guilan University of Medical Sciences
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
Research and Technology Department, Guilan University of Medical Sciences
Full name of responsible person
Mohammad Sadeq Mousavi
Position
Medical Student
Other areas of specialty/work
Street address
Poursina Hospital, Higher than the Census Bureau, Poursina intersection
City
Rasht
Postal code
Phone
+98 13 3355 2241
Fax
Email
arman.mousavi1989@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Guilan University of Medical Sciences
Full name of responsible person
DR.Hossien Ettehad
Position
Orthopaedic surgeon
Other areas of specialty/work
Street address
Poursina Hospital, Higher than the Census Bureau, Poursina intersection
City
rasht
Postal code
Phone
+98 13 3355 2241
Fax
Email
h.ettehad70@gums.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Orthopaedic Research Center of Guilan University of Medical Sciences
Full name of responsible person
Milad Shoa Kazemi
Position
Medical student
Other areas of specialty/work
Street address
City
Postal code
Phone
00
Fax
Email
miladkazemi_1367@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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