purpose of study:
The effect of pentoxifylline on C reactive protein level (an acute phase reactant) and dialysis adequacy in end stage renal disease patients under hemodialysis structure of study:
randomized, double blind,control with placebo
Patients referred to dialysis institute of Valiasr Hospital after matching for Age, Sex and Time that patients were under dialysis, randomly sent in two groups of drug and placebo. Patients and dialysis institute staff were not aware of which group is drug group and which one is placebo group.
inclusion criteria:
acceptance of written consent; End Stage Renal Disease; more than 15year; BMI between 15 - 35
exclusion criteria:
pentoxifylline use before study; no acceptance of written consent; abnormal LFT; hyper sensitivity reaction to pentoxifylline; active infection; recent malignancy; depression; recent ICH; recent retinal hemorrhage;dialysis period under 3 month.
population of study: end stage renal disease patients under hemodialysis referred to Valiasr hospital.
number of population of study:
80 patients.
intervention of study:
The effect of pentoxifylline on C reactive protein level (an acute phase reactant) and dialysis adequacy
time of study:
one month consumption of Pentoxifylline
primary results:
decrease in serum CRP level and increase in dialysis adequacy
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013120715695N1
Registration date:2014-01-28, 1392/11/08
Registration timing:prospective
Last update:
Update count:0
Registration date
2014-01-28, 1392/11/08
Registrant information
Name
Pardis ketabi Moghaddam
Name of organization / entity
Amiralmomenin hospital
Country
Iran (Islamic Republic of)
Phone
+98 86 3417 3601
Email address
dr.ketabimoghadam@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Arak University of Medical Sciences
Expected recruitment start date
2014-03-21, 1393/01/01
Expected recruitment end date
2015-02-20, 1393/12/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Pentoxifylline on C reactive protein level and dialysis adequacy in end stage renal disease patients under hemodialysis
Public title
The effect of Pentoxifylline on C reactive protein level and dialysis adequacy
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: acceptance of written consent; End Stage Renal Disease; more than 15year; BMI between 15 - 35
Exclusion criteria: pentoxifylline use before study; no acceptance of written consent; abnormal LFT; hyper sensitivity reaction to pentoxifylline; active infection; recent malignancy; depression;recent ICH; recent retinal hemorrhage; dialysis period under 3 months
Age
From 15 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Arak University of Medical Sciences
Street address
Pardis Site, Bbasij Square, Arak
City
Arak
Postal code
3848176941
Approval date
2013-09-23, 1392/07/01
Ethics committee reference number
92-148-12
Health conditions studied
1
Description of health condition studied
esrd
ICD-10 code
N18.5
ICD-10 code description
Chronic kidney Disease, stage 5
2
Description of health condition studied
Ischemic Heart Disease
ICD-10 code
120-125
ICD-10 code description
Angina pectoris, Acute myocardial infarction, Subsequent myocardial infarction, Certain current complications following acute myocardial infarction, Other acute ischaemic heart diseases, Chronic ischaemic heart disease,
Primary outcomes
1
Description
CRP
Timepoint
before and after receiving placebo or drug
Method of measurement
quantitative kit of CRP
Secondary outcomes
1
Description
Dialysis Adequacy
Timepoint
before and after dialysis and before and after receiving placebo or drug
Method of measurement
KT/V: K ( cc/min ) x time ( min ) / urea volume ( cc )
Intervention groups
1
Description
Pentoxifylline Tab 400 mg
daily
30 days in Intervention group
Category
Treatment - Drugs
2
Description
Starch Tab daily in Control group
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Dialysis Institute of Valiasr Hospital
Full name of responsible person
Pardis Ketabi Moghaddam
Street address
Valiasr Hospital, Sardaran Square, Arak
City
Arak
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Arak University of Medical Sciences
Full name of responsible person
Miss Jahani
Street address
Research and Education Site, Arak Medical University, Basij Square, Arak
City
Arak
Grant name
Grant code / Reference number
933
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Arak 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
Amiralmomenin Hospital
Full name of responsible person
Dr. Afsaneh Talayi
Position
Internist, Endocrinologist
Other areas of specialty/work
Street address
Amiralmomenin Hospital, Basij Square, Arak
City
Arak
Postal code
3848176941
Phone
+98 86 3417 3601
Fax
+98 34173630
Email
amoozesh@arakmu.ac.ir
Web page address
http://www.arakmu.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Amiralmomenin Hospital
Full name of responsible person
Dr Parvin Soltani
Position
Nephrologist
Other areas of specialty/work
Street address
Amiralmomenin Hospital, Basij Square, Arak
City
Arak
Postal code
3848176941
Phone
+98 86 3417 3601
Fax
+98 34173630
Email
dr.ketabimoghadam@arakmu.ac.ir
Web page address
http://www.arakmu.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Amiralmomenin Hospital
Full name of responsible person
Dr Pardis Ketabi Moghaddam
Position
Internal Medicine Assistant
Other areas of specialty/work
Street address
Amiralmomenin Hospital, Basij Square, Arak
City
Arak
Postal code
3848176941
Phone
+98 86 3417 3601
Fax
+98 34173630
Email
dr.ketabimoghadam@arakmu.ac.irgh_nyx@yahoo.ac.in
Web page address
http://www.arakmu.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)