Protocol summary

Summary
In this double blind clinical trial,40 patients admitted in cardiac department that candidate for CABG ,if prefer to accomplish in study are selected within including and excluding factors.All of them complete personal information sheet then the patients randomized divided in two groups.One group receipt Vasopressin and other group receipt Norepinephrine.In the day of admition 2ml blood sample taken in order to study about Blood Urea Nitrogen and Creainin .In both group before surgery arterial line fixed and blood sample taken for Arterial Blood Gas study.For first group Vasopressin infusion recommended(0.3µg/kg).For the other group Norepinephrine infusion recomended( 5µg /min).After end of surgery and before patient transfer to ICU,ABG sample taken and Echocardiography accomplish. 24hour after surgery 2ml blood sampl taken in order to study about Blood Urea Nitrogen and Creainin and investigate renal function. 24hour after surgery hemorhage volume in both group measured.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2016051023760N2
Registration date: 2017-04-05, 1396/01/16
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2017-04-05, 1396/01/16
Registrant information
Name
Mohammad Reza Jamshidi
Name of organization / entity
Zanjan University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 912 334 6346
Email address
jamshidianes@zums.ac.ir
Recruitment status
Recruitment complete
Funding source
Zanjan University of Medical Siences search validity
Expected recruitment start date
2016-01-09, 1394/10/19
Expected recruitment end date
2016-11-09, 1395/08/19
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of intravenous Vasopressin versus Norepinephrine on correction of cardiac function and renal function in low cardiac out put patient
Public title
Comparison effect of intravenous Vasopressin versus Norepinephrine on correction of cardiac function and renal function in low cardiac out put patient after CABG in Mosavi hospital at 1394
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusioncriteria:age 30yr and more;cardiac output more than 30%;ASA class1 Exclusion criteria:severe cardiac arrhithmia;heart faliure;cardiogenic shock;unstable hemodynamic;diabet mellitus;pulmonary disease;vascular disease;pulmonary HTN;pathologic change of liver;emergency CABG
Age
From 30 years old to 90 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size: 40
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
Zanjan University of Medical Sciences
Street address
Azadi blvd.
City
Zanjan
Postal code
4515613191
Approval date
2016-01-09, 1394/10/19
Ethics committee reference number
zums.rec.1394.276

Health conditions studied

1

Description of health condition studied
Coronary Artery Disease
ICD-10 code
I25.1
ICD-10 code description
Atherosclerotic heart disease

Primary outcomes

1

Description
Lelft Ventricular Contraction
Timepoint
Before intervention and 4 days afeter intervention
Method of measurement
Echocardiography

2

Description
Mean Arterial Pressure
Timepoint
Before surgery ,Before CPB,During CPB,After CPB and before transer to ICU
Method of measurement
Invasive Blood Pressure Monitoring

3

Description
Serum Creatinin
Timepoint
Before surgery and before transer to ICU
Method of measurement
Laboratory Elisa kit

4

Description
Volume of Hemorrage
Timepoint
End of surgery and every 6 houre until 24 houres after end of surgery
Method of measurement
Mililiter

5

Description
BUN
Timepoint
Before surgery and before transer to ICU
Method of measurement
Laboratory Elisa kit

Secondary outcomes

empty

Intervention groups

1

Description
Intrvention group1:Vasopressin Start infusion of vasopressin0.3µg/kg at off pump time and continu to end of surgery
Category
Treatment - Drugs

2

Description
Intervention group2:Norepinephrine Infusion of Norepinephrine at off pump time and continue until end of surgery
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Mousavi Hospital
Full name of responsible person
Dr.Mohammad Reza Jamshidi
Street address
Gavazang road
City
Zanjan

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Zanjan University Of Medical Sciences
Full name of responsible person
Dr. Alireza Shoghli
Street address
Zanjan University Of Medical Sciences
City
Zanjan
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Zanjan 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
Zanjan University of Medical Siences
Full name of responsible person
ِDr.Robab Azizi
Position
Anaesthesiology assistant
Other areas of specialty/work
Street address
Mousavi hospital,Gavazang Road,Post code4513056183
City
Zanjan
Postal code
4513956183
Phone
+98 24 3313 0000
Fax
+98 24 3313 0000
Email
robabazizi60@gmail.com
Web page address
www.zums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Zanjan University of Medical Sciences
Full name of responsible person
Dr.Mohammad Reza Jamshidi
Position
Fellowship of cardiac anaesthesia
Other areas of specialty/work
Street address
Mousavi hospital,Gavazang road,Post code 4513956183
City
Zanjan
Postal code
4513956183
Phone
+98 24 3313 1420
Fax
+98 24 3313 1419
Email
jamshidianes@zums.ac.ir
Web page address
www.zums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Zanjan University of Medical Siences
Full name of responsible person
Dr.Robab Azizi
Position
Anaesthesiology assistant
Other areas of specialty/work
Street address
Mousavi hpspital,Gavazang Road,Post code451956183
City
Zanjan
Postal code
4513956183
Phone
+98 24 3313 0000
Fax
+98 24 3313 0000
Email
robabazizi60@gmail.com
Web page address
www.zums.ac.ir

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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