In this research we evaluating effect of povidoneiodine in pleurodesis of massive pleural effusion. This single-center study was designed without blind and placebo. All patients with a history of malignant pleural effusion and dyspnea will be entered in study. If the patient does not wish to participate in the study or known case of renal dysfunction and thyroid disease will be excluded. Chest tube will be inserted and drainage of pleural effusion of the patients and after that, pleurodesis with povidone iodine will be considered. The success rate at specified intervals checked by chest radiograph. Kidney and thyroid function tests before and after pleurodesis study and laboratory changes will be recorded.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015071423202N1
Registration date:2015-08-11, 1394/05/20
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-08-11, 1394/05/20
Registrant information
Name
Manouchehr Aghajanzadeh
Name of organization / entity
Respiratory Research Center of Razi Hospital
Country
Iran (Islamic Republic of)
Phone
+98 13 3354 2460
Email address
m.aghajanzadeh@gums.ac.ir
Recruitment status
Recruitment complete
Funding source
guilan university of medical science
Expected recruitment start date
2015-07-23, 1394/05/01
Expected recruitment end date
2016-07-22, 1395/05/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of povidoneiodine pleurodesis in malignant pleural effusion
Public title
povidoneiodine pleurodesis
Purpose
Treatment
Inclusion/Exclusion criteria
inclusion criteria: patients with malignant and massive pleural effusion
exclusion criteria:underline thyroid disease; underline renal disease; Lack of consent to participate in research
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
1
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Guilan University of Medical Science
Street address
Research and Technology of University Building, Shahid Beheshti Blv-
City
Rasht
Postal code
Approval date
2015-06-09, 1394/03/19
Ethics committee reference number
IR.GUMS.REC.1394.41
Health conditions studied
1
Description of health condition studied
pleural effusion
ICD-10 code
C78.2
ICD-10 code description
Secondary malignant neoplasm of pleura
Primary outcomes
1
Description
successful pleurodesis
Timepoint
2 weeks- 4 weeks- 6 months after intervention
Method of measurement
chest X ray
Secondary outcomes
1
Description
BUN
Timepoint
before intervention-first day after and 4 weeks later
Method of measurement
laboratory test
2
Description
serum creatinin
Timepoint
before intervention-first day after and 4 weeks later
Method of measurement
laboratory test
3
Description
TSH
Timepoint
before intervention-first day after and 4 weeks later
Method of measurement
laboratory test
4
Description
T3
Timepoint
before intervention-first day after and 4 weeks later
Method of measurement
laboratory test
5
Description
T4
Timepoint
before intervention-first day after and 4 weeks later
Method of measurement
laboratory test
Intervention groups
1
Description
thoracostomy tube will be inserted and after depletion of pleural effusion, pleurodesis will be done with 20cc of 20% povidoneiodine and 60 cc normal saline.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Razi Hospital
Full name of responsible person
Dr Hadi Kahrom
Street address
Razi Hospital, Sardar Jangal St
City
Rasht
2
Recruitment center
Name of recruitment center
Arya Hospital
Full name of responsible person
Dr Manouchehr Aghajanzadeh
Street address
Beside the Sardar Jangal Airport, Anzali Blv
City
Rasht
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Respiratory Center-University of Guilan
Full name of responsible person
Sara Massahnia
Street address
Razi Hospital, Sardar Jangal Avenue
City
Rasht
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Respiratory Center-University of Guilan
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
Guilan University od Medical Science
Full name of responsible person
Hadi Kahrom
Position
resident of sergury
Other areas of specialty/work
Street address
Razi Hospital-Sardar Jangal Avenue
City
Rasht
Postal code
Phone
+98 13 3354 2460
Fax
Email
hadikahrom@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Guilan University of medical Science
Full name of responsible person
Manouchehr Aghajanzadeh
Position
full professor-thorax surgeon
Other areas of specialty/work
Street address
Razi Hospital-Sardare Jangal Avenue
City
Rasht
Postal code
Phone
+98 13 3354 2460
Fax
Email
maghajanzadeh2003@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Guilan University of Medical Science
Full name of responsible person
Hadi Kahrom
Position
resident of surgery
Other areas of specialty/work
Street address
Razi Hospital- Sardar Jangal Avenue
City
Rasht
Postal code
Phone
+98 13 3354 2460
Fax
Email
hadikahrom@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)