The aim of the study
We aimed to compare the efficacy of doxycycline and povidon iodine in treating of pleural effusion and determines appropriate alternative.
Designed to study
In a blinded clinical trial, 72 patients who are candidate for pleurodesis, including recurrence or malignant cases, enroll and randomly divide into two groups.
The main inclusion and exclusion criteria:
Candidates for pleurodesis, recurrent or malignant cases who have expansion of lungs after chest tube insertion which confirm by anterior-posterior chest radiography.
Interventions
In the case group 20 ml povidon Iodine 10% diluted with 50 ml normal saline 0/9% and 10 ml lidocaine 2% and injected to pleural space via chest tube. In control cases doxycycline 7 mg per kilogram diluted with 50 ml normal saline 0.9% and 10 ml lidocaine 2% and injected to pleural space via chest tube. In both groups the chest tube clamped and after one hour, the clamp opened and chest tube connected to bottle which connected to suction with minus 10 centimeters of water up to 48 to 72 hours for helping to lungs expansion.
Time of intervention:
Time of intervention is after insertion of chest tube and confirming of lungs expansion by chest radiography.
Outcome of study:
Main outcomes are pain and infection due to pleurodesis.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015052918168N3
Registration date:2016-04-08, 1395/01/20
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-04-08, 1395/01/20
Registrant information
Name
Hamid Reza Hemmati
Name of organization / entity
Semnan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 23 3343 7822
Email address
dr.hahemmati@semums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research and Technology, Semnan University of Medical Sciences
Expected recruitment start date
2015-10-23, 1394/08/01
Expected recruitment end date
2016-10-21, 1395/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of Doxycycline and Povidon Iodine for in treatment of pleural effusion in patients who candidate for pleurodesis
Public title
Use of Doxycycline and Povidon Iodine for in treatment of pleural effusion
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Candidates for pleurodesis, recurrent or malignant cases .
Exclusion criteria: none
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
72
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
A random number table used for randomization.
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic Committee of Semnan University of Medical Sicense
Street address
Basidj Boulevard
City
Semnan
Postal code
3519747167
Approval date
2015-08-20, 1394/05/29
Ethics committee reference number
IR.SEMUMS.REC.1394.91
Health conditions studied
1
Description of health condition studied
Pleural effusion
ICD-10 code
J90
ICD-10 code description
Pleural effusion, not elsewhere classified
Primary outcomes
1
Description
Pain
Timepoint
Daily after intervention
Method of measurement
Numeric Pain Rating Scale
Secondary outcomes
1
Description
Empyema
Timepoint
In the 7, 30, 60 and 90 day after intervention
Method of measurement
Examination and assessment
Intervention groups
1
Description
In the case group 20 ml povidon Iodine 10% diluted with 50 ml normal saline 0.9% and 10 ml lidocaine 2% and injected to pleural space via chest tube and clamped for one hour.
Category
Treatment - Drugs
2
Description
In control cases doxycycline 7 mg per kilogram diluted with 50 ml normal saline 0.9% and 10 ml lidocaine 2% and injected to pleural space via chest tube and clamped for one hour.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Kowsar Hospital
Full name of responsible person
Armin Hajizadeh
Street address
Amin Avenue, Al-Ghadir square, Basidj Boulevard
City
Semnan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research of Semnan University of Medical Sciences
Full name of responsible person
Mohammad Reza Asgari
Street address
Basidj Boulvard
City
Semnan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor for Research of Semnan 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
Semnan University of Medical Sciences
Full name of responsible person
Armin Hajizadeh
Position
Medical Student (intern)
Other areas of specialty/work
Street address
Kowsar Hospital, Amin Avenue, Basidj Boulevard
City
Semnan
Postal code
3519899951
Phone
+98 23 3343 7821
Fax
Email
mehrdadzahmatkesh@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Dr. Hamid Reza Hemmati
Position
Thorax Surgeon/ Assistant professor
Other areas of specialty/work
Street address
Kowsar hospital, Amin Avenue, Al Ghadir Square, Basidj Boulevard
City
Semnan
Postal code
3519899951
Phone
+98 23 3343 7821
Fax
Email
dr.hahemmati@semums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Semnan University of Medical Sciences
Full name of responsible person
Mehrdad Zahmatkesh
Position
Research expert
Other areas of specialty/work
Street address
Kowsar Hospital, Amin Avenue, Basidj Boulevard
City
Semnan
Postal code
3519899951
Phone
+98 23 3343 7838
Fax
Email
mehrdadzahmatkesh@semums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)