Objective: Studying the effect of vasopressin in preventing vasoplegic shock from cardiopulmonary bypass
Design: Prospective randomized clinical trial
Setting and conduct: Seventy five adult patients candidate for elective cardiac surgery using cardiopulmonary bypass (CPB), randomly will be allocated in three vasopressin, phenylephrine and placebo groups (N=25). Anesthesia induction and maintenance will be done using intravenous midazolam, fentanyl and cisatracurium. With starting CPB infusion of vasopressin (0.1 IU/min), phenylephrine (0.1 µg/kg/min) or normal saline (2 ml/h) was started in Vasopressin, Phenylephrine and placebo groups, respectively and continued up to 4 hours after weaning from CPB. Patients hemodynamic were managed using appropriate vasodilator or vasoconstrictor (Mean arterial blood pressure 60-80 mmHg during CPB and systolic pressure 100-120 mmHg after CPB).
Inclusion criteria: All patients 18 up to 70 years olds who are candidate for elective cardiac surgery using cardiopulmonary bypass
Exclusion Criteria: Urgent Surgery; Surgery without cardiopulmonary bypass; Diabetes mellitus; Respiratory, hepatic or renal disease
Intervention: Starting infusion of vasopressin 0.1 IU/min or phenylephrine (0.1 µg/kg/min) with starting of cardiopulmonary bypass in vasopressin and phenylephrine groups, respectively and continuing it up to 4 hours after weaning from CPB.
Outcome measures: Needs to vasoactive drugs and postoperative complications
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201408201127N2
Registration date:2014-10-18, 1393/07/26
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2014-10-18, 1393/07/26
Registrant information
Name
Eissa Bilehjani
Name of organization / entity
Tabriz University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 41 3329 6124
Email address
bilehjanii@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Tabriz University of Medical Sciences
Expected recruitment start date
2014-09-23, 1393/07/01
Expected recruitment end date
2015-03-18, 1393/12/27
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Infusion of low dose of vasopressin versus phenylephrine for prevention of cardiopulmonary bypass induced vasoplegic syndrome in patients undergoing
Public title
Infusion of low dose of vasopressin versus phenylephrine for prevention of cardiopulmonary bypass induced vasoplegic syndrome in patients undergoing coronary artery bypass grafting surgery
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: Patients 18 up to 70 years olds who are candidate for elective cardiac surgery using cardiopulmonary bypass
Exclusion Criteria: Urgent Surgery; Surgery without cardiopulmonary bypass; Diabetes mellitus; Respiratory, hepatic or renal disease
Age
From 18 years old to 70 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
75
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Using stratified permuted block randomization method, 75 patients will be allocated in three vasopressin, phenylephrine and placebo groups (N=25).
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Sciences Ethics Committee of Tabriz University of Medical Sciences
Street address
Golgasht, Daneshgah Street, Tabriz
City
Tabriz
Postal code
Approval date
2011-08-20, 1390/05/29
Ethics committee reference number
9266
Health conditions studied
1
Description of health condition studied
Cardiopulmonary bypass induced vasoplegic shock
ICD-10 code
I70-I79
ICD-10 code description
Diseases of arteries, arterioles and capillaries
Primary outcomes
1
Description
severity of post operative vasoplegic shock
Timepoint
post cardiopulmonary bypass and post operative period
Method of measurement
Needs to vasoactive drugs
Secondary outcomes
1
Description
Post operative complications
Timepoint
Post operatively in intensive care unite
Method of measurement
Clinical evaluation
Intervention groups
1
Description
Intervention group1: Starting infusion of vasopressin (Exir pharmaceutical co. Iran) 0.1 IU/min with starting of cardiopulmonary bypass and continuing it up to 4 hours after weaning from cardiopulmonary bypass.
Category
Treatment - Drugs
2
Description
Intervention group2: Starting infusion of phenylephrine (West-ward Pharmaceutical Corp. USA) 0.1 µg/kg/min (prepared as 5 mg in 50 ml normal saline) with starting of cardiopulmonary bypass and continuing it up to 4 hours after weaning from cardiopulmonary bypass.
Category
Treatment - Drugs
3
Description
Placebo group: Starting NaCl 0.9% Infusion (2 ml/h) with starting of cardiopulmonary bypass and continuing it up to 4 hours after weaning from cardiopulmonary bypass.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Madani Heart Hospital
Full name of responsible person
Eissa Bilehjani
Street address
Madani Heart Center, Daneshgah Street, Tabriz
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research of Tabriz University of Medical Sciences
Full name of responsible person
Mohammad Reza Rashidi
Street address
Tabriz University of Medical Sciences, Daneshgah Street, Tabriz
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 of 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
Medicine faculty, Tabriz University of Medical Sciences
Full name of responsible person
Hassan Soleiman Pour
Position
Vice Chancellor for research of Tabriz University of Medical Sciences
Other areas of specialty/work
Street address
Madani Heart Center, Daneshgah Street, Tabriz
City
Tabriz
Postal code
Phone
+98 41 3336 4667
Fax
Email
soleimanpourh@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
Solmaz Fakhari
Position
Assistant Professor in Anesthesiology
Other areas of specialty/work
Street address
Madani Heart Center, Daneshgah Street, Tabriz
City
Tabriz
Postal code
516615573
Phone
+98 41 3337 3950
Fax
+98 41 3337 3950
Email
solmaz_fakhari@yahoo.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Eissa Bilehjani
Position
Assistant Professor in Anesthesiology
Other areas of specialty/work
Street address
Madani Heart Center, Daneshgah Street, Tabriz
City
Tabriz
Postal code
Phone
+98 41 3332 1454
Fax
+98 41 3337 3950
Email
bilehjanii@tbzmed.ac.ir
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)