Appointment of effect of pentoxifylline on inflammatory and biochemical markers of hemodialysis patients
Design
This RCT study is conducted on 50 hemodialysis patients who referred to the hemodialysis ward of Shahid Beheshti hospital in Yasuj city. Patients randomly (Random Permuted Blocks) were divided in to intervention(3 month pentoxifylline) and control(without drug) group respectively.
Settings and conduct
This study was conducted on hemodialysis patients refering to hemodialysis center of Shahid Beheshti Hospital, Yasuj.
Participants/Inclusion and exclusion criteria
Inclusion criteria: Patients aged>18 years; patients who were dialysed at least three times per week for a 3 month period.
Exclusion criteria: Liver disease, malignancy, AIDS; patients who have active infectious disease in previous 2 month ; kidney transplantation; blood disorders; cardiac arrhythmia; patient who take NSAID and steroids; immune deficiency; taking pentoxifylline in previous 3 month
Intervention groups
In a 3 month period, intervention group patients take 400 mg pentoxifylline once daily, and control group patient observed without drug.
Main outcome variables
IL-6, IL-10, TNF-a, CRP
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20150622022869N6
Registration date:2018-02-07, 1396/11/18
Registration timing:registered_while_recruiting
Last update:2018-02-07, 1396/11/18
Update count:0
Registration date
2018-02-07, 1396/11/18
Registrant information
Name
Moslem Sedaghattalab
Name of organization / entity
Yasuj University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 74 3322 0163
Email address
m.sedaghattalab@yums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for research of Yasuj University of Medical Sciences
Expected recruitment start date
2017-10-23, 1396/08/01
Expected recruitment end date
2018-03-20, 1396/12/29
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of pentoxifylline on inflammatory and biochemical markers of hemodialysis patients
Public title
Effect of pentoxifylline on inflammatory and biochemical markers of hemodialysis patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients aged>18 years
Patients who were dialysed at least three times per week for a 3 month period
Presence of well vascular access
Written and conscious satisfaction
Exclusion criteria:
Liver disease, malignancy, AIDS
Patients who have active infectious disease in previous 2 month
Allergy to pentoxifylline and other methylxanthines
Kidney transplantation
Blood disorders
Cardiac arrhythmia
Hypotention
Taking NSAID and steroids
Immune deficiency;
Taking pentoxifylline in previous 3 month
Age
From 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
50
Randomization (investigator's opinion)
Randomized
Randomization description
Random Permuted Blocks was used for randomization with blocks of size of 4 that after every 4 patients there was an equal number assigned to each treatment. For each block, one of the arrangements (CCII, CICI, ICCI, IICC, ICIC, CIIC) was randomly chosen(C= Control, I= Intervention).
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Yasuj University of Medical Science
Street address
Yasuj University of Medical Science, Motahari street, Yasuj city
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
75917-41417
Approval date
2016-08-04, 1395/05/14
Ethics committee reference number
IR.YUMS.REC.1396.85
Health conditions studied
1
Description of health condition studied
End stage kidney disease
ICD-10 code
N18.5
ICD-10 code description
Chronic kidney disease, stage 5
Primary outcomes
1
Description
IL-6
Timepoint
before intervention and 3 months after intervention
Method of measurement
ELISA
2
Description
IL-10
Timepoint
before intervention and 3 months after intervention
Method of measurement
ELISA
3
Description
TNF-α
Timepoint
before intervention and 3 months after intervention
Method of measurement
ELISA
4
Description
CRP
Timepoint
before intervention and 3 months after intervention
Method of measurement
ELISA
Secondary outcomes
1
Description
Drug reaction
Timepoint
3 months after intervention
Method of measurement
Questionnaire
Intervention groups
1
Description
Intervention: Pentoxifylline tablet 400 mg every nights for 3 month
Category
Treatment - Drugs
2
Description
Control: usual supervision
Category
N/A
Recruitment centers
1
Recruitment center
Name of recruitment center
Hemodialysis ward of Shahid Beheshti hospital
Full name of responsible person
Moslem Sedaghattalab
Street address
Montazeri St, Shahid Beheshti Hospital
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
7591794857
Phone
+98 74 3322 4721
Email
moslem.sedaghattalab@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for research of Yasuj University of Medical Sciences
Full name of responsible person
Hossein Mary Oryad
Street address
Yasuj University of Medical Sciences, Motahari street, Yasuj city
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
75917-41417
Phone
+98 74 3334 6078
Email
oryad.hossein@yums.ac.ir
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 Yasuj University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Yasuj University of Medical Sciences
Full name of responsible person
Moslem Sedaghattalab
Position
Assistant professor, Internist
Latest degree
Specialist
Other areas of specialty/work
Internal Medicine
Street address
Emam Sajad hospital, Dr.Jalil street, Yasuj city
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
75919-94579
Phone
+98 74 3322 0163
Fax
Email
moslem.sedaghattalab@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Yasuj University of Medical Sciences
Full name of responsible person
Moslem Sedaghattalab
Position
Assistant Professor, Internist
Latest degree
Specialist
Other areas of specialty/work
Internal Medicine
Street address
Emam Sajad hospital, Dr.Jalil street, Yasuj city
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
75919-94579
Phone
+98 74 3322 0163
Fax
Email
moslem.sedaghattalab@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Yasuj University of Medical Sciences
Full name of responsible person
Moslem Sedaghattalab
Position
Assistant professor, Internist
Latest degree
Specialist
Other areas of specialty/work
Internal Medicine
Street address
Emam Sajad hospital, Dr.Jalil street, Yasuj city, Postal code: 75919-94579
City
Yasuj
Province
Kohgilouyeh-va-Boyrahmad
Postal code
75919-94579
Phone
+98 74 3322 0163
Fax
Email
moslem.sedaghattalab@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Some data such as major outcomes will be sharing.
When the data will become available and for how long
1398
To whom data/document is available
collegiate institution
Under which criteria data/document could be used
only above instances
From where data/document is obtainable
Valiollah Talebi
valitalebi.md@gmail.com
What processes are involved for a request to access data/document