Aim & design: One of the most common heart CABG surgery, the blood vessels in other parts of the body such as the saphenous vein is grafted to the occluded artery, thereby blocking the path disappears. Given the prevalence of the use of inotropic drugs during CABG surgery and renal effects of these drugs in long-term use of low-risk choices necessity, if you have less vasopressin renal complications can be used as a drug of choice inotropic. Hence, we decided to study the effect of vasopressin to reduce bleeding and to maintain renal perfusion and prevent renal dysfunction in patients undergoing CABG surgery compared with norepinephrine, which is used to improve the overall survival of these patient.
Inclusion criteria:
The criteria for inclusion of participants were age30 and more, had been diagnosed by angiography, and absence of mental problems.
Exclusion criteria: Patients who had had chronic renal failure and creatinin more than 1.5, were excluded.
Interventions: Vasopressin in 0.01-0.04 U/min when mean arterial pressure 50 mmHg and Norepinephrin in 1-4 µ/ min when mean arterial pressure 50 mmHg
Out comes: Blood urine nitrogen Before intervention, after intervention and Creatinin Before intervention, after intervention
General information
Acronym
Open Heart surgery
IRCT registration information
IRCT registration number:IRCT201412054256N4
Registration date:2015-02-14, 1393/11/25
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2015-02-14, 1393/11/25
Registrant information
Name
Nasrin Samadi
Name of organization / entity
Ardabil University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 45 1551 3057
Email address
na.samadi@arums.ac.ir
Recruitment status
Recruitment complete
Funding source
Ardabil University of Medical Sciences
Expected recruitment start date
2015-01-10, 1393/10/20
Expected recruitment end date
2015-06-20, 1394/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of vasopressin and norepinephrine on Renal function of patients undergoing CABG in Emam Khomeini hospital of Ardabil
Public title
Effect of vasopressin and norepinephrine on Renal function of patients undergoing CABG in Emam Khomeini hospital of Ardabil
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: age 30 years old and more; IHD had been diagnosed by angiography, and absence of mental problems.
Exclusion criteria: patients who, had had chronic renal failure and creatinin more than 1.5 were excluded.
Age
No age limit
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
120
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
Ardabil university of medical sciences
Street address
Ardabil university of medical sciences
City
Ardabil
Postal code
Approval date
2014-07-27, 1393/05/05
Ethics committee reference number
9114
Health conditions studied
1
Description of health condition studied
Open heart sergury
ICD-10 code
I20-25
ICD-10 code description
Ischaemic heart diseases
Primary outcomes
1
Description
Blood urine nitrogen
Timepoint
Before intervention, after intervention
Method of measurement
Biochemical blood test, urine volume in 24 hours
2
Description
Creatinin
Timepoint
Before intervention, after intervention
Method of measurement
Biochemical blood test, urine volume in 24 hours
Secondary outcomes
1
Description
In crease creatinin, decease clearance creatinin
Timepoint
Before,24 hours after intervention
Method of measurement
Biochemical blood test, urine volume in 24 hours
Intervention groups
1
Description
Vassopressin 0.01-0.04 u/min in artery pressure below 50 mm/Hg
Category
Treatment - Drugs
2
Description
control: Norepinephrine 1-4 u/min in artery pressure below 50 mm Hg
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Emam khomeini hospital of Ardabil
Full name of responsible person
Mohammadi Hassan pour
Street address
sh jedi st, Ardabil,Iran
City
Ardabil
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Shahram Habib zadeh
Street address
Ardabil
City
Ardabil
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ardabil 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
Ardabil university of medical sciences
Full name of responsible person
Jafar Vakili
Position
Anesthesioligy residant
Other areas of specialty/work
Street address
Ardabil university of medical sciences
City
Ardabil
Postal code
Phone
+98 45 3325 1401
Fax
Email
Vakili_jafar@yahoo.com, na.samadi@arums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Mohammad Hassan pourdargah
Position
flowship of cardiac anesthesiology
Other areas of specialty/work
Street address
Ardabil University of Medical Sciences
City
Ardabil
Postal code
Phone
+98 45 3325 1401
Fax
Email
Drmhd3051@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Ardabil University of Medical Sciences
Full name of responsible person
Nasrin Samadi
Position
Faculty member
Other areas of specialty/work
Street address
Ardabil University of Medical Sciences
City
Ardabil
Postal code
Phone
Fax
Email
na.samadi@arums.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)