Despite the use of low-osmolarity contrast media and prophylactic hydration, contrast-induced nephropathy (CIN) remains an unsolved problem of the contemporary medical practice. So this study will be conducted in order to comparison of 3 protective regimens for preventing contrast-induced nephropathy in high risk patients undergoing coronary angiography in Shahid- Beheshti hospital Qom, 2012.
In this work, 147 patients, who have at least one of the following risk factors: age >65 years, diabetes mellitus, heart failure (25%> ejection fraction >40%), renal insufficiency (creatinine³1.5mg/dl), control hypertension (BP<160/100 mmHg) or recent use of NSAID’S, ACE inhibitor and amino glycosides drugs will be studied.
The patients will be randomized 1 of 3 prophylactic regimens: 49 patients will be assigned to infusion of sodium bicarbonate solution, 49 patients to oral NAC plus hydration with normal saline, 49 patients to standard hydration with normal saline (control group). Serum creatinine and blood urea nitrogen (BUN) levels will be measured in the morning on the first day before coronary angiography (day 1) and in the morning on second day after the procedure. PH urine level will be measured in the morning on the day before and after coronary angiography
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201202062560N6
Registration date:2012-02-28, 1390/12/09
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2012-02-28, 1390/12/09
Registrant information
Name
Mohammad reza Yeganehkhah
Name of organization / entity
Qom University of Medical Sciences and Health Services
Country
Iran (Islamic Republic of)
Phone
+98 21 6630 4368
Email address
yeganehkhah@muq.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research of Qom University of Medical Sciences
Expected recruitment start date
2012-02-20, 1390/12/01
Expected recruitment end date
2012-08-22, 1391/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of three protective regimens for preventing contrast-induced nephropathy in high risk patients undergoing coronary angiography
Public title
Comparison of 3 Protective regimens for preventing contrast-induced nephropathy in high risk patients
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Patients, who have at least one of the following risk factors: 1) Age>65 years, 2) Diabetes mellitus, 3) Heart failure (25%>ejection fraction>40%), 4) Renal insufficiency (creatinine³1.5mg/dl), 5) Control hypertension (systolic and diastolic blood pressure <160 mm Hg and < 100 mm Hg, respectively), 6) Recent use of NSAID’S, ACE inhibitor and amino glycosides drugs. Exclusion criteria : 1) Pregnancy & lactation, 2) Allergy to radiographic contras,t 3) Have of cardogenic shock, pulmonary edema, multiple myeloma, pulmonary ventilation and emergency catheterization 4) Serum creatinine levels< 4 mg/dL and preexisting dialysis 5) Exposure to contrast medium within the preceding 48 hours of the study, 6) Receive of diuretics, N-acetylcystein, sodium bicarbonate, theophylline, dopamine, mannitol, fenoldopam, metformin and NSAID’S during the study period. 7) Need for continuous hydration therapy (e.g., sepsis), 8) Uncontrolled hypertension (systolic and diastolic blood pressure >160 mm Hg and >100 mm Hg, respectively)
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
147
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
Qom University of Medical Sciences and Health Services
Street address
Qom University of Medical Sciences and Health Services, Saheli st.
City
Qom
Postal code
Approval date
2012-02-02, 1390/11/13
Ethics committee reference number
18958/34/ت
Health conditions studied
1
Description of health condition studied
Contrast-induced nephropathy
ICD-10 code
N14.3
ICD-10 code description
Nephropathy induced by heavy metals
Primary outcomes
1
Description
Decrease of contrast-Induced nephropathy
Timepoint
Serum creatinine and blood urea nitrogen (BUN) levels will be measured in the morning on the first day before coronary angiography (day 1) and in the morning on second day after the procedure. PH urine level will be measured in the morning on the day before and after coronary angiography.
Method of measurement
Serum creatinine, blood urea nitrogen (BUN) and PH urine levels will be measured, and creatinine clearance will be calculated according to the Cockcroft-Gault equation.
Secondary outcomes
empty
Intervention groups
1
Description
(1) The sodium bicarbonate solution will be prepared by adding 150 mL of 1000-mEq/L sodium bicarbonate to 850 mL of sodium chloride. Patients will receive the same dose of sodium bicarbonate solution (3mL/ kg/ h) for 1 hour before contrast media, followe by an infusion of 1 mL/kg per hour for 6 hours after the procedure.
Category
Treatment - Drugs
2
Description
(2) All patients will be received the same dose of sodium chloride (1 mL/kg/ h upper limit 100 mL/h) for 12 hours before and 12 hours after the procedure. The study drug (acetylcysteine 600 mg) will be administered orally twice daily for two doses before the procedure and two doses after the procedure
Category
Treatment - Drugs
3
Description
(3) All patients will be received the same dose of sodium chloride (1 mL/kg/h upper limit 100 mL/h) for 12 hours before and 12 hours after the procedure.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid- Beheshti hospital
Full name of responsible person
Street address
City
Qom
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Qom University of Medical Sciences and Health Services
Full name of responsible person
Koohpaei Ali Reza
Street address
Qom University of Medical Sciences and Health Services, Saheli st.
City
Qom
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Qom University of Medical Sciences and Health Services
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
Qom University of Medical Sciences and Health Services