The purpose of this study was to reduce the effects of heart surgery.For this purpose, 100 patients underwent elective CABG with EF: 35-50% with no history of kidney or liver failure, or diabetes or seizures preoperatively reffered to masih daneshvari hospital Divided into 2 groups: the first group received low-dose vasopressin started 30 minutes before the end of CPB and so it continues after 1h, The second group received saline by the same method And the effect of vasopressin on the improvement of cardiac function in patients during separation from cardiopulmonary pump reviews And the need for inotropic support, arrhythmia and ischemia evaluated
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2015010212642N7
Registration date:2015-01-18, 1393/10/28
Registration timing:prospective
Last update:
Update count:0
Registration date
2015-01-18, 1393/10/28
Registrant information
Name
Majid Golestani Eraghi
Name of organization / entity
Shahid Beheshti University Of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 3336 0547
Email address
dr.golestani@arakmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Deputy for Research and Technology shahid Beheshti University of Medical Sciences
Expected recruitment start date
2015-02-20, 1393/12/01
Expected recruitment end date
2015-06-22, 1394/04/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effects of vasopressin on the improvement of cardiac function in patients with ventricular dysfunction during separation from cardiopulmonary pump
Public title
Effect of vasopressin on complications of cardiac surgery
Purpose
Prevention
Inclusion/Exclusion criteria
inclusion criteria: CABG surgery; elective surgery; EF=30-50%
exclusion criteria: emergency surgery; Concomitant valve surgery and coronary; renal and liver failure before surgery; diabetes melitus; allergy to vasopresin; history of seizure
Age
No age limit
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
100
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee, Deputy for Research and Technology Shahid Beheshti University of Medical Sciences
Street address
Daneshjoo Ave, Velenjak
City
Tehran
Postal code
Approval date
2013-06-25, 1392/04/04
Ethics committee reference number
Sbmu1.REC.1392.11
Health conditions studied
1
Description of health condition studied
cardiac disease
ICD-10 code
I25.1
ICD-10 code description
Atherosclerotic heart disease
Primary outcomes
1
Description
blood pressure
Timepoint
Before, during and after cardiopulmonary bypass
Method of measurement
mmHg with Using a mercury manometer
2
Description
heart rate
Timepoint
Before, during, and after CPB
Method of measurement
with pulseoxymeter device
Secondary outcomes
1
Description
blood lactate
Timepoint
Before, during, and after CPB
Method of measurement
in term of mmol/l with using arterial blood analyser device
Intervention groups
1
Description
vasopresin with 0.03 microgr/kg dosage starting 30minute before end of CPB and continue until 1hour after that.
Category
Prevention
2
Description
normal saline with 0.03 microgr/kg dosage starting 30minute before end of CPB and continue until 1hour after that.
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Masih Daneshvari Hospital
Full name of responsible person
Majid Golestani Eraghi
Street address
Darabad Ave
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Deputy for Research and Technology Shahid Beheshti University of Medical Sciences
Full name of responsible person
Afshin Zarghi
Street address
Daneshjoo Ave, Velenjak
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Deputy for Research and Technology Shahid Beheshti 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
Person responsible for scientific inquiries
Contact
Name of organization / entity
Departman of Anesthesia Shahid Beheshti University Of Medical Science
Full name of responsible person
Alireza Jahangirifard
Position
Fellowship of Cardiac Anesthesia
Other areas of specialty/work
Street address
Daneshjoo Ave, Velenjak
City
Tehran
Postal code
Phone
+98 21 2712 2525
Fax
Email
alirezajahangiri@sbmu.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Anesthesia group, Shahid Beheshti University of Medical Sciences
Full name of responsible person
Majid Golestani Eraghi
Position
Fellowship specialty intensive care
Other areas of specialty/work
Street address
Masih Daneshvari Hospital, Darabad Ave
City
Tehran
Postal code
Phone
00
Fax
Email
dr.golestani@arakmu.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)