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Levamizole effect on mortality reduction in patients with more than 50% burn of body surface area

Protocol summary

Summary
The effect of Levamizole on improvement of immune system is well known. Obviously, infection is one of the major causes of death in burned patients. If this drug could reduce the infection rates in burn victims, then the mortality rate would also be decreased. One hundred patients with more than 50%, 3rd degree burn of body surface area are randomly divided into two groups. Patients with electrical or chemical burns, medical illness or on chronic use of medications are excluded from the study. The hospital care for all patients is the same as for the standard medical and surgical treatments. In group one Levamizole 100 mg/day is added to the treatment plan. In group two this drug is not administrated. Age, sex, cause of burn, percentage of burn area, burn degree, and specific body area, mortality, hospital stay, operation frequency and blood transfusion are evaluated and compared.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT138903044020N1
Registration date:
Registration timing: na

Last update:
Update count: 0
Registration date
empty
Registrant information
Name
Mohamad Javad Fatemidokht
Name of organization / entity
Iran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8870 8415
Email address
mjfch@iums.ac.ir
Recruitment status
Recruitment complete
Funding source
Iran university of medical sciences
Expected recruitment start date
2010-07-23, 1389/05/01
Expected recruitment end date
2011-07-23, 1390/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Levamizole effect on mortality reduction in patients with more than 50% burn of body surface area
Public title
Levamizole effect on mortality reduction in patients with more than 50% burn of body surface area
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: patients that are admitted within 24 hours after burn with more than 50%, 3rd degree burn of body surface area. Exclusion criteria: patients who are admitted after 24 hours or treated in other centers before admission in hospital; patients with electrical or chemical burns, medical illness or on chronic use of medications.
Age
No age limit
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 100
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
Iran University of Medical Scinces
Street address
Hemmatt Highway
City
Tehran
Postal code
5983-14155
Approval date
2010-01-05, 1388/10/15
Ethics committee reference number
896

Health conditions studied

1

Description of health condition studied
Burns over 50%
ICD-10 code
T20-T25
ICD-10 code description
Burns and corrosions of external body surface, specified by site

2

Description of health condition studied
Burns over 50%
ICD-10 code
T26-T28
ICD-10 code description
Burns and corrosions confined to eye and internal organs

3

Description of health condition studied
Burns over 50%
ICD-10 code
T29-T32
ICD-10 code description
Burns and corrosions of multiple and unspecified body regions

Primary outcomes

1

Description
Mortality
Timepoint
Daily
Method of measurement
Died in hospital due to complications of burns

Secondary outcomes

1

Description
Hospital stay
Timepoint
daily
Method of measurement
From start to completion of admission

2

Description
Visit surgery
Timepoint
daily
Method of measurement
no. of transferring to the operating room

3

Description
The need for blood transfusion
Timepoint
daily
Method of measurement
Volume transfused during hospitalization

Intervention groups

1

Description
Levamizole, 100 mg, daily in oral form
Category
Treatment - Drugs

2

Description
no interventionin in control group
Category
N/A

Recruitment centers

1

Recruitment center
Name of recruitment center
Center of medical education and treatment of Hazrat fatemeh
Full name of responsible person
Mohamad Javad Fatemidokht
Street address
Street 21, Jamal al-Din Asad Abadi Avenue
City
Tehran

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
Seyed Abbas Motevaliyan
Street address
Hemat highway
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran 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
Iran University Of Medical Sciences
Full name of responsible person
Mohamad Javad Fatemidokht
Position
Plastic and reconstructive surgeon, Associated professor
Other areas of specialty/work
Street address
Hazrat fatemeh hospital, 21 St., Seyed Jamaledin Asad Abadi Ave.
City
Tehran
Postal code
1433933111
Phone
00982188708415 - 00982188723150
Fax
+98 21 8870 8415
Email
mjfch@iums.ac.ir , istatis_pn@yahoo.com , fatemi41@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Iran University Of Medical Sciences
Full name of responsible person
Mohamad Javad Fatemidokht
Position
Plastic and reconstructiove surgeon, Associated professor
Other areas of specialty/work
Street address
Hazrat fatemeh hospital, 21 St., Seyad Jamaledin Asad Abadi Ave.
City
Tehran
Postal code
1433933111
Phone
00982188723150-88708415
Fax
+98 21 8870 8415
Email
mjfch@iums.ac.ir , fatemi41@yahoo.com , istatis_pn@yahoo.com
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Iran University Of Medical Sciences
Full name of responsible person
Pegah Nafar
Position
BS Biology
Other areas of specialty/work
Street address
Hazrat fatemeh hospital, 21 St., Seyed Jamaledin Asad Abadi Ave.
City
Tehran
Postal code
1433933111
Phone
00982188708415 - 00982188723150
Fax
+98 21 8870 8415
Email
istatis_pn@yahoo.com , mjfch@iums.ac.ir , fatemi41@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
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