The aim of this study was to compare the effect of PTX vs placebo on serum concentrations of C-Reactive Protein (CRP) in patients on hemodialysis. All ESRD patients of Ali ibn Abi Talib's hemodialysis ward that at least 2 months underwent hemodialysis treatment were selected. 54 patients were randomly allocated to an intervention or a control group. Patients of the intervention group received one PTX tablet (400 mg) once a day, whereas controls received one placebo. All patients had three hemodialysis sessions per week, each session take 4 hours. Clinical evaluations were performed just after intervention and then as monthly. Serum samples of both group at 0, 2 and 4 months, for measuring CRP concentrations taken and delivered to laboratory. Also laboratory results were recorded in patients’ history forms. All laboratory measurements were performed in a specific laboratory to minimize the error. To eliminate the source of bias in this study, patients were balanced with regard to disease, age and gender. Finally, the results of two groups compared.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2016032722540N2
Registration date:2016-05-13, 1395/02/24
Registration timing:retrospective
Last update:
Update count:0
Registration date
2016-05-13, 1395/02/24
Registrant information
Name
Iman Poorkeykhaei
Name of organization / entity
Zahedan university of medical sciences
Country
Iran (Islamic Republic of)
Phone
+98 54 3341 3396
Email address
iman.poorkeykha@zaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Zahedan University of Medical Sciences
Expected recruitment start date
2015-04-04, 1394/01/15
Expected recruitment end date
2015-10-07, 1394/07/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the effect of Pentoxifylline on serum concentrations of C-Reactive Protein (CRP) in hemodialysis patients
Public title
Pentoxifylline effect in serum C-Reactive Protein (CRP) Concentration level in hemodialysis patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: Arteriovenous fistula as vascular access, Hemodialysis patients at least 2 months prior trial.
Exclusion criteria: Chronic active liver disease, Any infectious disease 2 months before the study, Failed kidney graft, Hypersensitivity to PTX or other methylxanthines, Hemorrhage/clotting disorders, Risk for worsening pre-existing cardiac arrhythmias or arterial hypotension, Treatment with antibiotics, non-steroidal anti-inflammatory drugs, steroids, immunosuppressives, statins or PTX 3 months previous to the study
Age
From 18 years old to 70 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
54
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Zahedan University of Medical Sciences
Street address
Khalij Fars highway - Zahedan University of Medical Sciences
City
Zahedan
Postal code
Approval date
2014-06-22, 1393/04/01
Ethics committee reference number
6836
Health conditions studied
1
Description of health condition studied
End stage renal desease patients who underwent hemodialysis treatment
ICD-10 code
N18.5
ICD-10 code description
Chronic kidney disease, stage 5
Primary outcomes
1
Description
Serum CRP concentrations
Timepoint
At 0, 2 and 4 months of intervention
Method of measurement
Serum CRP concentrations
Secondary outcomes
empty
Intervention groups
1
Description
Intervention: Pentoxifylline: PTX tablet (400 mg) orally once a day
Category
Treatment - Drugs
2
Description
Control: One starch tablet once a
day
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Hemodialysis ward of Ali ibn Abi Talib hospital in zahedan
Full name of responsible person
Dr Ali Alidadi
Street address
Khalij Fars highway - Ali ibn Abi Talib hospital
City
Zahedan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Dr Mohsen Taheri
Street address
Khalij Fars highway - Ali ibn Abi Talib hospital
City
Zahedan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zahedan 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
Zahedan University of Medical Sciences
Full name of responsible person
Dr Ali Alidadi
Position
Nephrologist
Other areas of specialty/work
Street address
Khalij Fars highway - Zahedan university of medical sciences
City
Zahedan
Postal code
Phone
+98 54 3342 5571
Fax
Email
Dr.alidadi@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zahedan university of medical sciences
Full name of responsible person
Dr Ali Alidadi
Position
Nephrologist
Other areas of specialty/work
Street address
Khalij Fars highway - Zahedan university of medical sciences
City
Zahedan
Postal code
Phone
+98 54 3342 5571
Fax
Email
Dr.alidadi@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Zahedan University of Medical Sciences
Full name of responsible person
Dr Reza Golabci-Fard
Position
Residence of internal medicine
Other areas of specialty/work
Street address
Khalij Fars highway - Zahedan university of medical sciences
City
Zahedan
Postal code
Phone
+98 54 3342 5571
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)