The purpose of this study is evaluation of diagnostic accuracy of serum and plural lipid profile in patients with exudative pleural effusion. 40 patients admitted to Masih Daneshvari hospital with a diagnosis of exudative pleural effusion, not just non-randomized, blinded, placebo without control and without the intervention group entered the trial phase. In these patients, the presence of pleural effusion on radiography or ultrasound is proven and provides the ability to do thoracentesis. Patients have not renal failure or coagulopathy.In patients with exudative pleural effusion according to light criteria Lipid profile of serum and pleural fluid (cholesterol, LDL, HDL and triglyceride) is measured . The sensitivity, specificity and diagnostic accuracy of each of the variables on the brink of, in the diagnosis of exudative pleural effusion will determined.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015083112642N18
Registration date:2015-11-08, 1394/08/17
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-11-08, 1394/08/17
Registrant information
Name
Majid Golestani Eraghi
Name of organization / entity
Shahid Beheshti University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 3336 0547
Email address
dr.golestani@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research and Technology Shahid Beheshti University of Medical Sciences
Expected recruitment start date
2015-09-23, 1394/07/01
Expected recruitment end date
2015-12-22, 1394/10/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of diagnostic accuracy of serum and plural lipid profile in patients with exudative pleural effusion.
Public title
Lipid profile accuracy in the diagnosis of exudative pleural effusion
Purpose
Diagnostic
Inclusion/Exclusion criteria
Inclusion criteria: Exist pleural effusion on radiography or ultrasound; Exudative pleural effusion diagnosis; Ability to do thoracentesis.
Exclusion criteria: Renal failure; coagulopathy; Skeletal deformities that impair thoracentesis; Lack of consent
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
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
Vice Chancellor for Research and Technology Ethics Committee Shahid Beheshti University of Medical S
Street address
Daneshjoo Ave, Velenjak
City
Tehran
Postal code
Approval date
2015-08-30, 1394/06/08
Ethics committee reference number
IR.SBMU.SM.REC.1394.27
Health conditions studied
1
Description of health condition studied
Pleural effusion
ICD-10 code
j91
ICD-10 code description
Pleural effusion in conditions classified elsewhere
Primary outcomes
1
Description
Pleural fluid lipid profile
Timepoint
After thoracentesis
Method of measurement
According gram per deciliter and using laboratory kits
2
Description
Serum lipid profile
Timepoint
After thoracentesis
Method of measurement
According igram per deciliter and using laboratory kits
Secondary outcomes
1
Description
Pleural fluid protein
Timepoint
After thoracentesis
Method of measurement
According gram per deciliter and using laboratory kits
2
Description
Serum protein
Timepoint
After thoracentesis
Method of measurement
According milligram per deciliter and using laboratory kits
Intervention groups
1
Description
Lipid profile in patients with exudative pleural effusion samples of pleural fluid and serum samples will be analyzed
Category
Diagnosis
Recruitment centers
1
Recruitment center
Name of recruitment center
Masih Daneshvari Hospital
Full name of responsible person
Majid Golestani Eraghi
Street address
Darabad Ave
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research and Technological Shahid Beheshti University of Medical Sciences
Full name of responsible person
Afshin Zarghi
Street address
Daneshjoo Ave, Velenjak
City
Tehran
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 and Technological Shahid Beheshti 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
Person responsible for scientific inquiries
Contact
Name of organization / entity
Department of Anesthesiology Shahid Beheshti University of Medical Sciences
Full name of responsible person
Majid Golestani Eraghi
Position
Fellowship subspecialty critical care
Other areas of specialty/work
Street address
Darabad Ave
City
Tehran
Postal code
Phone
+98 21 2712 2525
Fax
Email
dr.golestani@sbmu.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Department of Anesthesiology Shahid Beheshti University of Medical Sciences
Full name of responsible person
Majid Golestani Eraghi
Position
Fellowship subspecialty critical care
Other areas of specialty/work
Street address
Darabad Ave
City
Tehran
Postal code
Phone
+98 21 2712 2525
Fax
Email
dr.golestani@sbmu.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)