(1) Objectives: Our aim in this study is to evaluate the effect of hydration with normal saline alone or in combination with sodium bicarbonate in preventing contrast induced nephropathy. (2) Design: 350 patients from both genders undergoing coronary angiography in Imam Reza Hospita, Tabriz and Mousavi Hospital, Zanjan after qualifying the inclusion and exclusion criteria and obtaining the informed consent, the patients enter the trial process. (3) Setting and conduct: Patients will randomly assign to receive infusion of normal saline with or without sodium bicarbonate 6 hours before and 6 hours after contrast media injection. Both groups will receive N-acetyl cysteine. Contrast induced nephropathy was defined as an increase of ≥25% or 0.5mg/dl in pre-procedure serum creatinine at 48 h after procedure. (4) Participants including major eligibility criteria: Participants will be selected among the patients undergoing coronary angiography. The key inclusion criteria is elective angiography and the key exclusion criteria are pre-existing end-stage renal disease requiring dialysis; cardiogenic shock; uncontrolled hypertension; recent exposure to radiographic media; serum creatinine level above 4 mg/dl. (5) Intervention:Using normal saline alone or in combination with sodium bicarbonate 6 hours before and 6 hours after injection of contrast media. (6) Main outcome measures: Main outcome measures is contrast induced nephropathy.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201305205311N2
Registration date:2013-05-26, 1392/03/05
Registration timing:retrospective
Last update:
Update count:0
Registration date
2013-05-26, 1392/03/05
Registrant information
Name
Bahram Sohrabi
Name of organization / entity
Tabriz University of Medical Sciences and Health Services
Country
Iran (Islamic Republic of)
Phone
+98 41 1335 2077
Email address
sohrabib@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice chancellor for research, Tabriz University of Medical Sciences
Expected recruitment start date
2011-03-21, 1390/01/01
Expected recruitment end date
2011-06-22, 1390/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of hydration with normal saline with or without sodium bicarbonate in preventing contrast induced nephropathy in coronary angiography
Public title
The effect of normal saline with or without sodium bicarbonate in preventing contrast induced nephropathy in coronary angiography
Ethics committee of Tabriz University of Medical Sciences
Street address
Tabriz university of medical sciences, Daneshgah Square
City
Tabriz
Postal code
Approval date
2010-08-20, 1389/05/29
Ethics committee reference number
8816
Health conditions studied
1
Description of health condition studied
Nephropathy
ICD-10 code
N14.1
ICD-10 code description
Nephropathy induced by other drugs, medicaments and biological substances
Primary outcomes
1
Description
Contrast induced nephropathy
Timepoint
6 hours before and 48 hours after intervention
Method of measurement
measuring serum creatinine
Secondary outcomes
empty
Intervention groups
1
Description
In normal saline group, normal saline will be infused 6 hours before and 6 hours after injection of contrast media.
Category
Treatment - Drugs
2
Description
In normal saline and bicarbonate group, normal saline and sodium bicarbonate will be infused 6 hours before and 6 hours after injection of contrast media.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Madani Heart hospital
Full name of responsible person
Dr. Bahram Sohrabi
Street address
Madani heart hospital, Golbad Ave.,
City
Tabriz
2
Recruitment center
Name of recruitment center
Ayatollah Moosavi educational hospital
Full name of responsible person
Dr. Khalil Mahmoody
Street address
City
Zanjan
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice chancellor for research, Tabriz University of Medical Sciences
Full name of responsible person
Dr. Seyyed Kazem Shakouri
Street address
Vice chancellor for research, Tabriz University of Medical Sciences, Daneshgah square
City
Tabriz
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, Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Bahram Sohrabi
Position
Fellowship of intervention/ Associate professor
Other areas of specialty/work
Street address
Madani Heart hospital, Golbad Ave.,
City
Tabriz
Postal code
Phone
+98 41 1336 3846
Fax
Email
sohrabib@tbzmed.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Bahram Sohrabi
Position
Fellowship of intervention
Other areas of specialty/work
Street address
Madani Heart hospital, Golbad Ave.,
City
Tabriz
Postal code
Phone
+98 41 1336 3846
Fax
Email
sohrabib@tbamed.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Dr. Bahram Sohrabi
Position
Fellowship of intervention/ associate professor
Other areas of specialty/work
Street address
Madani Heart hospital, Golbad Ave.,
City
Tabriz
Postal code
Phone
+98 41 1336 3846
Fax
Email
sohrabib@tbzmed.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)