Determine and compare the clinical effects of adding the Albumin and Starch to the prime solution in adult patients undergoing heart valve surgery
Design
Clinical trial, with control group، with parallel groups، blinded، randomized
Settings and conduct
This study was performed on patients undergoing heart valve surgery in Rajaie Heart Center. Patients were randomly assigned to case and control groups. In case group 50 cc albumin and in control group 500cc Hydroxyethyl Starch were added to the prime solution. Clinical outcomes were evaluated in both groups.
Participants/Inclusion and exclusion criteria
Adult patients undergoing heart valve surgery using by cardiopulmonary bypass entered the study; Withdrawal of the patient and the pump's extended time (more than 150 minutes) were excluded.
Intervention groups
In the intervention group, Albumin was used for the prime the oxygenator, in control group, Starch was used for the prime the oxygenator.
Main outcome variables
Determination and comparison of coagulation parameters in albumin and starch groups; amount of the used blood products; Length of stay in the intensive care unit; amount of Serum creatinine level.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20190512043568N1
Registration date:2019-06-24, 1398/04/03
Registration timing:retrospective
Last update:2019-06-24, 1398/04/03
Update count:0
Registration date
2019-06-24, 1398/04/03
Registrant information
Name
Egbal Ahadmohebi
Name of organization / entity
Rajei heart center hospital
Country
Iran (Islamic Republic of)
Phone
+98 41 3230 0066
Email address
egbalmohebi@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-08-31, 1397/06/09
Expected recruitment end date
2019-01-05, 1397/10/15
Actual recruitment start date
2019-01-06, 1397/10/16
Actual recruitment end date
2019-04-11, 1398/01/22
Trial completion date
2019-04-16, 1398/01/27
Scientific title
Comparison of clinical effects of adding Albumin and Hydroxy ethyl Starch to prime solution in adult patients undergoing heart valve surgery
Public title
"Albumin in heart surgery"؛ Effect of Starch in valve heart surgery "
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Adults undergo heart valve surgery by cardiopulmonary by pass
Exclusion criteria:
Cancer
History of heart surgery
Endocardit
Platllet under 100000 unit
Emergence operation
Hemoglubin under 10
Ejectionfraction under 25%
Aortic clamp time above 120 minutes and pump time above 150 minutes
Age
From 17 years old to 70 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Investigator
Sample size
Target sample size:
80
Actual sample size reached:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Permuted block randomization.
80 blocks include 40 patients in Albumin group and 40 patients in Starch group .
Use sealed envelope .
Blinding (investigator's opinion)
Double blinded
Blinding description
The prime solution was prepared by a technician and covered then poured to the oxygenator and the perfusionist did not aware the kind of prime solution.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics commitee of Tehran shahid Rajaei heart center
Street address
Valiasr Ave., shahid Rajaei heart center
City
Tehran
Province
Tehran
Postal code
1995614331
Approval date
2019-01-05, 1397/10/15
Ethics committee reference number
IR.RHC.REC.1397.072
Health conditions studied
1
Description of health condition studied
Assess the efect of Albumin and Starch on patients undergo heart valve surgery
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
Protrombin time ( Pt )
Timepoint
Pre operation , 24 and 48 hours post operation
Method of measurement
Labratory tests
2
Description
Amount use of Red Blood cells
Timepoint
Before and after the operation daily
Method of measurement
Laboratory tests
3
Description
Amount of used platelets
Timepoint
Before and after the operation daily.
Method of measurement
Laboratory tests
4
Description
Creatinine
Timepoint
Pre operation, 24 and 48 hours post operation
Method of measurement
Laboratory tests
5
Description
Intensive care unit stay
Timepoint
Entrance time to intensive care unit until discharge intensive care unit
Method of measurement
Intensive care unit stay (day)
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group:in this group added 50 cc Albumin to Oxygenator prime solution .
Category
Treatment - Other
2
Description
Control group:in this group added 500 cc Starch to oxygenator prime solution .
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Rajaei heart center
Full name of responsible person
Alireza Ghavidel
Street address
Valiasr Ave., Rajaei heart center
City
Tehran
Province
Tehran
Postal code
1995614331
Phone
+98 21 2204 2026
Fax
Email
Rajaei@domian.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Ragaei heart center
Full name of responsible person
Maziyar Kholampour
Street address
Valiasr Ave., Rajaei heart center
City
Tehran
Province
Tehran
Postal code
1995614331
Phone
+98 21 2204 2026
Email
rajaei@domian.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ragaei heart center
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Rajaei heart center
Full name of responsible person
Egbal Ahadmohebi
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Valiasr Ave., Rajaei heart center
City
Tehran
Province
Tehran
Postal code
1995614331
Phone
+98 21 2204 2026
Email
egbalmohebi@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Rajaei heart center
Full name of responsible person
Egbal Ahadmohebi
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Valiasr Ave., Rajaei heart center
City
Tehran
Province
Tehran
Postal code
1995614331
Phone
+98 21 2204 2026
Email
egbalmohebi@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Rajaei heart center
Full name of responsible person
Egbal Ahadmohebi
Position
Student
Latest degree
Bachelor
Other areas of specialty/work
Nursery
Street address
Valiasr Ave., Rajaei heart center
City
Tehran
Province
Tehran
Postal code
1995614331
Phone
+98 21 2204 2026
Email
egbalmohebi@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available