120 patients referred for evaluation of abdomen by contrast-enhanced CT Scan were included in this study. Patients were randomly allocated into two groups, group A and group B. Exclusion criteria: severe fatty liver; diabetes, hepatic tumor and portal vein thrombosis. Each group received a different contrast agent through IV route. Group A received 150 cc iodixanol (visipaque)300mgI/ml and group B received 150 cc iopromide(Ultravist300mgI/ml). CT scan were obtained with Somatom helical CT scanner (Simense, Germany). The contrast agents were injected via a power injector via antecubital vein using a gauge 18 needle. Images were obtained 60 second after injection. Injection pressure after each injection was recorded. Hepatic, portal and aortal enhancements were determined 60 second after injection. Adverse effects in 1 hour after injection and up to 1 week after injection were recorded using two questionnaires.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT138904144316N1
Registration date:2011-01-08, 1389/10/18
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-01-08, 1389/10/18
Registrant information
Name
Farideh Gharekhanloo
Name of organization / entity
Hamedan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 81 1264 0064
Email address
f_gharekhanloo@umsha.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Hamedan University of Medical sciences
Expected recruitment start date
2009-09-23, 1388/07/01
Expected recruitment end date
2010-05-22, 1389/03/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the efficacy and adverse effects of visipaque and Ultravist in Contrast-enhanced CT Scan
Public title
Comparison of the efficacy and adverse effects of visipaque and Ultravist in Contrast-enhanced CT Scan
Purpose
Diagnostic
Inclusion/Exclusion criteria
Inclusion criteria : patients reffered for abdomenoplevic CT
Exclusion criteria : renal disease, Diabetes, known drug reaction
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
120
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Hamedan University of Medical sciences Ethics Committee
Street address
Besat Hospital
City
Hamedan
Postal code
6514845411
Approval date
2010-03-09, 1388/12/18
Ethics committee reference number
253/3/54/16/p
Health conditions studied
1
Description of health condition studied
All of patients referred to abdominal and pelvic CT
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Increasing of contrast enhancement
Timepoint
60 seconds after injection
Method of measurement
dansitometry with CTscan appratus
Secondary outcomes
1
Description
complication post injection
Timepoint
To one week after injection
Method of measurement
registrationin questionare
Intervention groups
1
Description
injection contrast ultravist 300mgI/ml
Category
Diagnosis
2
Description
injection contrast of visi paque300mgI/ml
Category
Diagnosis
Recruitment centers
1
Recruitment center
Name of recruitment center
Department of Radiology, Besat Hospital
Full name of responsible person
Dr Farideh Gharekhanloo
Street address
Besat hospital
City
Hamedan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Hamedan University of Medical Sciences
Full name of responsible person
Dr Ghaleiha
Street address
Besat hospital
City
Hamedan
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, Hamedan 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
Hamedan University of Medical sciences
Full name of responsible person
Dr Farideh Gharekhanloo
Position
Academic member
Other areas of specialty/work
Street address
Besat hospital
City
Hamedan
Postal code
6514845411
Phone
+98 81 1264 0064
Fax
+98 81 1264 0064
Email
f_gharekhanloo@umsha.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Hamedan University of Medical sciences
Full name of responsible person
Dr Farideh Gharekhanloo
Position
Academic member
Other areas of specialty/work
Street address
Besat hospital
City
Hamedan
Postal code
6514845411
Phone
+98 81 1264 0064
Fax
+98 81 1264 0064
Email
f_gharekhanloo@umsha.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Hamedan University of Medical sciences
Full name of responsible person
Dr Farideh Gharekhanloo
Position
Academic member
Other areas of specialty/work
Street address
Besat hospital
City
Hamedan
Postal code
6514845411
Phone
+98 81 1264 0064
Fax
+98 81 1264 0064
Email
f_gharekhanloo@umsha.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)