(1) Determine the average levels of blood creatinine in the group receiving the NAC; To determine the effect of changes in serum creatinine in the group receiving pentoxifylline plus NAC; Determine and compare the prevalence of blood creatinine changes in the group receiving the NAC plus pentoxifylline with NAC alone; The frequency of contrast-induced nephropathy in patients undergoing coronary angiography (2) Controlled clinical trial (3) Measurement of serum creatinine level before angiography. Patients were randomly divided into two equal groups (4) The terms of inclusion: ckd with angiography and cardiac catheterization; Age greater than 18 and less than 75 years; Terms of withdrawal from the study follow-up treatment with theophylline in the previous month, furosemide, mannitol or dopamine, nonsteroidal anti-inflammatory drugs, renal failure; Patients with serum creatinine equal to or less than 1.5 mg per deciliter; Sensitivity to contrast material, emergency coronary angiography; Radiocontrast diagnostic use in the last 2 months for reasons other diagnostic; Congestive heart failure (5) The administration of NAC 1200 mg every 12 hours in addition to hydration the day before angiography and prescribed pentoxifylline 400 mg every 8 hours in addition to hydration and N-acetylcysteine. Measure and record patients' serum creatinine levels in both groups after 24 hours and compared with admission creatinine. (6) Serum creatinine
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015102624713N1
Registration date:2016-03-09, 1394/12/19
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2016-03-09, 1394/12/19
Registrant information
Name
Mahmood Kordi
Name of organization / entity
Zahedan University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 54 3328 7533
Email address
mkordi@zaums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research,Zahedan University of Medical Sciences
Expected recruitment start date
2016-01-09, 1394/10/19
Expected recruitment end date
2016-11-21, 1395/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effectiveness of oral pentoxifylline for the prevention of contrast nephropathy in CKD patients undergoing coronary angiography
Public title
Effectiveness of pentoxifylline in contrast induced nephropathy
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria of ckd patients with angiography and cardiac catheterization indication include:Age greater than 18 and less than 75 years,Patient satisfaction for the study
Exclusion criteria include : problems in patients follow up, treatment with theophylline, furosemide, mannitol or dopamine in last one month,use of Nonsteroidal anti-inflammatory drugs, aminoglycosides, N-acetylcysteine drugs,Renal failure patients with serum creatinine equal to or less than 1.5 mg per deciliter, Patients with an allergy to contrast material, Patients with Multiple myeloma, Pulmonary edema, Uncontrolled hypertension, patient required emergency angiography,
diagnostic use of radiocontrast material for patient in the last 2 months of other diagnostic reasons, congestive heart failure,pregnancy, lactation
Sensitivity to the NAC or pentoxifylline
Age
From 18 years old to 75 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
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 Zahedan Medical University of Science
Street address
Ethics Committee of Zahedan Medical University of Science, Zahedan Medical University of Science, Dr.Hesabi Square, Daneshgah Avenue, Zahedan
City
Zahedan
Postal code
Approval date
2015-09-23, 1394/07/01
Ethics committee reference number
IR.ZAUMS.REC.1394.221
Health conditions studied
1
Description of health condition studied
Contrast Nephropathy
ICD-10 code
N17, N18,
ICD-10 code description
Renal failure
Primary outcomes
1
Description
Serum Creatine
Timepoint
at admission, 24 h after intervention
Method of measurement
blood test based on miligram on decilitre
Secondary outcomes
1
Description
Contrast Nephropathy
Timepoint
24 houres
Method of measurement
blood test based on miligram on decilitre
Intervention groups
1
Description
In the control group N-acetylcysteine 1200 mg administered every 12 hours in addition to hydration will be prescribed
Category
Treatment - Drugs
2
Description
In the intervention group, prescribed pentoxifylline 400 mg every 8 hours plus hydration and NAC
In the control group , prescription N-acetylcysteine 1200 mg every 12 hours is recommended in addition to hydration
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Ali Ebn Abi Taleb Hospital, Zahedan
Full name of responsible person
Mahmoud kordi
Street address
Internal Medicine Department, Zahedan Ali ibn Abi Talib Hospital, Salamat Blvd, Dr.Hesabi Sq., Zahedan
City
Zahedan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research,Zahedan University of Medical Sciences
Full name of responsible person
Mohsen Taheri
Street address
, Vice chancellor for research, Zahedan University of Medical Sciences, Hesabi Square, Zahedan
City
Zahedan
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,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 Medical University
Full name of responsible person
Mahmoud Kordi
Position
Internal medicine residence
Other areas of specialty/work
Street address
Ali-ebn Abi Taleb Hospital,Salamat Blvd, Dr.Hesabi Sq.,Daneshgah Ave., Zahedan zahedan
City
Zahedan
Postal code
Phone
+98 54 3328 7533
Fax
Email
gharibeh.0001@gmail.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Zahedan Medical University
Full name of responsible person
Ali Alidadi
Position
Internal Medicine Specialist, Nephrologist
Other areas of specialty/work
Street address
Ali Ebn Abitaleb Hospital, Salamt Blvd, Dr.Hesabi Sq., Daneshgah Ave.,Zahedan
City
Zahedan
Postal code
Phone
+98 54 3329 5636
Fax
Email
drali.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
Mahmoud Kordi
Position
Internal Medicine Resident
Other areas of specialty/work
Street address
Ali-ebn Abi Taleb Hospital, Khalije Fars Blvd., Zahedan
City
Zahedan
Postal code
Phone
+98 54 3328 7533
Fax
Email
gharibeh.0001@gmail.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)