Comparative Study of Effect of One Third, Two Third and Normal Saline Serum on Prevention of Contrast Induced Nephropathy in Patients Undergoing Cardiac Angiography.
In this randomized clinical trial study, we intend to compare effect of one third, two third and normal saline serum on prevention of contrast induced nephropathy in patients undergoing cardiac angiography.
Among the patients(aged 15 to 85 years old) undergoing cardiac angiography, the patients who had glomerular filtration of below 60 or had serum creatinine of above or equal to 1.5 after performing routine tests in angiography ward of which part is serum creatinine were included in the study.
One third, two third or normal saline serum plus sodium bicarbonate will be prescribed randomly, one hour before angiography, during angiography and up to 6 hours after it with speed of 1 cc for each kg per hour.
Three and five days after angiography, serum creatinine will be tested and contrast induced nephropathy will be diagnosed based on increase of creatinine by 25% of basic limit or increase by more than 0.5 mg per decimeter .
Now, the number of contrast induced nephropathy cases will be compared in two groups of samples (two groups each containing 50 members) and will be statistically studied. In this study, Visipaque contract and at most 100 cc will be used and patients with severe valve diseases will not be included in the study due to their need for more contrast.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2013071413987N1
Registration date:2013-11-01, 1392/08/10
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2013-11-01, 1392/08/10
Registrant information
Name
Mohammad Kazem Karimi
Name of organization / entity
Kermanshah University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 83 1836 2022
Email address
kzk_137253@yahoo.com
Recruitment status
Recruitment complete
Funding source
Kermanshah University Of Medical Scienses, Vice chancellor for research
Expected recruitment start date
2013-08-23, 1392/06/01
Expected recruitment end date
2013-11-22, 1392/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative Study of Effect of One Third, Two Third and Normal Saline Serum on Prevention of Contrast Induced Nephropathy in Patients Undergoing Cardiac Angiography.
Public title
Studying Effect of One Third, Two Third and Normal Saline Serum on Contrast Induced Nephropathy.
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:Glomerular Filtration Rate(GFR) of below 60 or serum creatinine of above or equal to 1.5 mg/dl.
Exclusion criteria:Severe valve diseases and age less than 15 and more than 85 years.
Age
From 15 years old to 85 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single 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 Kermanshah University of Medical Sciences
Street address
Building number two, Shahid Beheshti Blvd. Kermanshah
City
Kermanshah
Postal code
6714673159
Approval date
2010-08-20, 1389/05/29
Ethics committee reference number
53925
Health conditions studied
1
Description of health condition studied
Contrast Induced Nephropathy
ICD-10 code
T65.6
ICD-10 code description
Paints and dyes, not elsewhere classified
Primary outcomes
1
Description
creatinine
Timepoint
On admission,3 and 5 days after angiography
Method of measurement
Based on milligram per deciliter and by automated analyzer
Secondary outcomes
empty
Intervention groups
1
Description
Intervention1:A group of patients will be given sodium bicarbonate plus one third and two third serum randomly, with speed of 1 cc for each kg per hour one hour before, , during and up to 6 hours after angiography. Sodium Bicarbonate 7.5%, each 100 cc contains; 7.5 gram sodium bicarbonate, Iran-Samen Pharmaceutical Company.
One third and two third serum, each 100 cc contains; 3.33 gram dextrose and 0.3 gram sodium chloride, Iran Pharmaceutical Products Company.
Category
Prevention
2
Description
Intervention2: Second group of patients will be given sodium bicarbonate plus normal saline serum randomly, with speed of 1 cc for each kg per hour one hour before, , during and up to 6 hours after angiography.
Normal saline 9%: each 100 cc contains 9 gram sodium chloride,Iran Pharmaceutical Products Company.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Ali Heart Centre
Full name of responsible person
Mohammad Kazem Karimi
Street address
Shahid Beheshti Blvd. kermanshah
City
Kermanshah
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Kermanshah University of Medical Sciences,vice chancellor for research
Full name of responsible person
Kermanshah University of Medical Sciences,vice chancellor for research
Street address
Medical College, Shahid Shiroodi Blvd. University Street,Kermanshah
City
Kermanshsh
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kermanshah University of Medical Sciences,vice chancellor for research
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
Kermanshah University of Medical Sciences
Full name of responsible person
Mohammad Kazem Karimi
Position
Cardiology resident
Other areas of specialty/work
Street address
Imam Ali Heart Centre, Shahid Beheshti Blvd. Kermanshah
City
Kermanshah
Postal code
6715847134
Phone
+98 83 1836 2022
Fax
+98 83 1836 0043
Email
kzk_137253@yahoo.com dr_hashemkazerani@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Mohammad Kazem Karimi
Position
Cardiology resident
Other areas of specialty/work
Street address
Imam Ali Heart Centre, Shahid Beheshti Blvd. Kermanshah
City
Kermanshah
Postal code
6715847134
Phone
+98 83 1836 2022
Fax
+98 83 1836 0043
Email
kzk_137253@yahoo.com dr_hashemkazerani@yahoo.com
Web page address
www.imamali.kums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Kermanshah University of Medical Sciences
Full name of responsible person
Mohammad Kazem Karimi
Position
Cardiology resident
Other areas of specialty/work
Street address
Imam Ali Heart Centre, Shahid Beheshti Blvd. Kermanshah
City
Kermanshah
Postal code
6715847134
Phone
+98 83 1836 2022
Fax
+98 83 1836 0043
Email
heartcentre@kums.ir kzk_137253@yahoo.com
Web page address
www.imamali.kums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)