Patients which are undergoing elective CAG will be entered in the study. For all patients questionnaire will fill. Patients will be divided 2 groups; oxygen receiving group and non receiving oxygen group. First group will receive nasal oxygen 2-3 lit/min from 10 min before starting of the procedure up to the end of the procedure. Second group will inhale from the oxygen room. ABG will be taken from all of the patients before receiving oxygen and at the end of the procedure. All of the patients receive the same type of contrast media. Contrast media dosing will be from 100 cc up to 200cc.1cc/kg /hour isotonic saline infusion will be started for all of the patients from 12 hours before up to 12 hours after the procedure. Diuretics will hold one day before the procedure. Serum creatinin will be checked before and 48 hours after the procedure. End results will be analyzed with statistical software.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2014082618936N1
Registration date:2014-10-10, 1393/07/18
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-10-10, 1393/07/18
Registrant information
Name
Farzane Sadat Minoo
Name of organization / entity
Imam Khomeini Hospital
Country
Iran (Islamic Republic of)
Phone
+98 21 6658 1568
Email address
fs-minoo@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Nefrology research center, Tehran University of Medical Sciences
Expected recruitment start date
2014-09-01, 1393/06/10
Expected recruitment end date
2014-12-01, 1393/09/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of supplemental oxygen in prevention of contrast nefropathy in patients referring to angiography center.
Public title
Effect of supplemental oxygen in prevention of contrast nefropathy
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: male or female patients older than 35 years old.
Exclusion criteria: cardiogenic shock; CHF; ACS; acute MI; COPD; ESRD under dialysis; O2 SAT < %90; need for emergency CABG.
Age
From 35 years old to 85 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
430
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
Tehran University of Medical Sciences
Street address
Tehran University of Medical Sciences, Ghods street, Keshavarz bulevard
City
Tehran
Postal code
Approval date
2014-08-05, 1393/05/14
Ethics committee reference number
24524
Health conditions studied
1
Description of health condition studied
Contrast nefropathy
ICD-10 code
N14.3
ICD-10 code description
Nephropathy induced by heavy metals
Primary outcomes
1
Description
serum creatinin
Timepoint
48 hours later
Method of measurement
laboratory
Secondary outcomes
empty
Intervention groups
1
Description
Control group will recieve normal saline 1ml/kg/h startin 12hours before to 12 hours after contrast agent administration. Patients will receive 100-200ml contrast agent. Diuretics will be held 24 hours before contrast administration.
Category
Prevention
2
Description
Intervention group:these patients will recieve nasal oxygen 2-3 litr/min from 10 min befor procedure up to the end of the procedure in addition to normal saline 1ml/kg/h from 12 hours before to 12 hours after contrast administration. They will recieve 100-200 ml contrast agent. Diuretics will be held 24 hours before contrast administration.
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Rajaiy Heart Center
Full name of responsible person
Dr Salman Nikfarjam
Street address
Angiography ward, Rajaiy Heart Center, valieasr-niayesh crossroad
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor of Research, Tehran University of Medical Sciences
Full name of responsible person
Dr Masoud Younesian
Street address
Tehran University of Medical Sciences, Ghods street, Keshavarz bulevard
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Vice Chancellor of Research, Tehran 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
Tehran University of Medical Sciences
Full name of responsible person
Elham Ramezanzade
Position
Nefrology fellow ship
Other areas of specialty/work
Street address
Nephrology Research Center, Imam Khomeini Hospital, Gharib St.,
City
Tehran
Postal code
00982166581568
Phone
+98 21 6658 1568
Fax
Email
rz.elam58@gmail.com; dr.cardiolog58@yahoo.com
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Farzane Sadat Minoo
Position
Assistany professor
Other areas of specialty/work
Street address
Nenefrology research center,imam khomeini hospital,gharib sreet,Tehran
City
tehran
Postal code
00982166581568
Phone
+98 21 6658 1568
Fax
Email
fs-minoo@sina.tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Farzane Sadat Minoo
Position
Assistant professor
Other areas of specialty/work
Street address
Nefrology research center,imam khomeini hospital,gharib street.Tehran
City
Tehran
Postal code
Phone
Fax
Email
fs-minoo@sina.tums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)