The Comparison of effect of Valuven versus ringer solution in cardiopulmonary bypass prime on the postoperative bleeding and renal function in coronary artery bypass graft surgery
Objective: To compare the effects of Valuven versus ringer solution in cardiopulmonary bypass prime on the postoperative bleeding and renal function in coronary artery bypass graft surgery.
Design: prospective, randomized Clinical trial.
Inclusion criteria: patients undergoing coronary artery bypass graft (CABG) for the first time.
Exclusion criteria: undergoing cardiac surgery for the second time; emergency coronary artery bypass; coagulation disorders prior to surgery; the preoperative clopidogrel (Plavix); congestive heart failure before surgery; renal failure before surgery (creatinine greater than (1 / 3) with a previous history of heart surgery; heart failure; coagulation disorders including abnormal PT and PTT, INR, PLAT; kidney disease included high chromium 1.3 and taking Plavix (clopidogrel).
Methods: 60 patients were divided into two groups of 30.
Patients in group A received 1500 cc Ringer as a prime solution during preparation of (CPB).
Patients in group B received Valuven1500 ml, 130/04 (hydroxyethyl starch) during preparation of CPB. Monitoring of vital signs is recorded.
After sternotomy and grafting, patient cannulation is performed by the surgeon and the CPB device is connected. Aorta is clamped and cold blood cardioplegia solution with antigrad method will be injected. Cardioplegia solution is cold blood type and same in all patients.
Simultaneously patient is cooled to the 34 to 32 degrees. Distal graft anastomosis is performed at the time of arrest and warming the patients begins. Patient is wined from CPB patients based on standard protocols and the patient is transferred to the ICU. Finally, the post-operative drainage of blood discharge in the ICU within the first 24 hours and patient's kidney function and urine out will be checked.
The amount of blood transfusion during and after surgery recorded and blood samples taking from both groups for the tests including CR - Na-K -HB- hematocrit- PT- PTT-INR before surgery and 24 hours after surgery in the ICU.
Hemodynamic changes at the arrival to the ICU and 6 and 24 hours after surgery will be recorded.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT2017041519470N56
Registration date:2017-04-21, 1396/02/01
Registration timing:registered_while_recruiting
Last update:
Update count:0
Registration date
2017-04-21, 1396/02/01
Registrant information
Name
Farzaneh Masihi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3647 4270
Email address
masihif@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Vice Chancellor for Research, Shiraz University of Medical Sciences
Expected recruitment start date
2017-04-16, 1396/01/27
Expected recruitment end date
2017-09-23, 1396/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Comparison of effect of Valuven versus ringer solution in cardiopulmonary bypass prime on the postoperative bleeding and renal function in coronary artery bypass graft surgery
Public title
The Comparison of effect of Valuven versus ringer solution in cardiopulmonary bypass prime on the postoperative bleeding and renal function in coronary artery bypass graft surgery
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria: patients undergoing coronary artery bypass graft (CABG) for the first time.
Exclusion criteria: undergoing cardiac surgery for the second time; emergency coronary artery bypass; coagulation disorders prior to surgery; the preoperative clopidogrel (Plavix); congestive heart failure before surgery; renal failure before surgery (creatinine greater than (1 / 3) with a previous history of heart surgery; heart failure; coagulation disorders including abnormal PT and PTT, INR, PLAT; kidney disease included high chromium 1.3 and taking Plavix (clopidogrel).
Age
From 40 years old to 75 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size:
60
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Sciences
Street address
Vice Chancellor of research, Shiraz University of Medical Sciences, 7th floor, central building of Shiraz University of Medical Sciences, Zand street
City
Shiraz
Postal code
Approval date
2010-09-23, 1389/07/01
Ethics committee reference number
IR.SUMS.MED.REC.1394.31
Health conditions studied
1
Description of health condition studied
Coronary Artery Bypass Surgery
ICD-10 code
125.1
ICD-10 code description
Atherosclerotic heart disease
Primary outcomes
1
Description
bleeding
Timepoint
during and after surgery
Method of measurement
Observasion
Secondary outcomes
1
Description
lab data (CR - Na-K -HB- hematocrit- PT- PTT-INR )
Timepoint
before surgery and 24 hours after surgery in the ICU
Method of measurement
blood sample
Intervention groups
1
Description
Patients in group A received 1500 cc Ringer as a prime solution during preparation of (CPB).
Category
Treatment - Drugs
2
Description
Patients in group B received Valuven1500 ml, 130/04 (hydroxyethyl starch) during preparation of CPB. Monitoring of vital signs is recorded.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahi Faghihi Hospital
Full name of responsible person
Alireza Sadeghi Gilavani
Street address
Shahid Faghihi Hospital, Zand Street
City
Shiraz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Vice Chancellor for Research, Shiraz University of Medical Sciences
Full name of responsible person
Dr Seed Basir Hashemi
Street address
Vice chancellor of research,7th floor of central building of Shiraz University of Medical Sciences, Zand street
City
Shiraz
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, Shiraz 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
Shiraz University of Medical Sciences
Full name of responsible person
Elahe allahyari
Position
Fellow ship of cardoanesthesiology
Other areas of specialty/work
Street address
Anesthesiology Department, Faghihi Hospital, Zand Street
City
Shiraz
Postal code
Phone
+98 71 3647 4270
Fax
Email
allahyarye@sums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz Universiy of Medical Sciences
Full name of responsible person
Elahe Alahyari
Position
Cardio-anesthesiologist
Other areas of specialty/work
Street address
Anesthesiology Department, Faghihi Hospital, Zand Street
City
Shiraz
Postal code
Phone
00
Fax
Email
allahyary.elahe@gmail.com
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Farzaneh Masihi
Position
MS in english teaching ,BS in anesthesia/English Consultant
Other areas of specialty/work
Street address
5th floor, Mohammad Rasul Allah Research Tower, Khalili Street
City
Shiraz
Postal code
Phone
+98 71 3647 4270
Fax
Email
masihifarzaneh@yahoo.com
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)