Determine the relationship between 5% albumin dose and body fluid balance in newborn and infants
Design
Two arm parallel group randomised trial with blinded postoperative care and outcome assessment
Settings and conduct
The location of this research is in the operating room and pediatric cardiac care unit.
In this study, pediatric cardiologist, cardiologist, perfusionist and nurses are blind to the study.
Participants/Inclusion and exclusion criteria
1. Parental consent to participate in the research project
2. The age of 5 day to 2year
3. Weight less than or equal to 10 kg
4. Patients candidated for open heart surgery
5. Congenital anomaly of the heart
6. Duration of pump for at least one hour and maximum three hours
Intervention groups
The intervention groups in this study are newborn and infants with congenital heart disease that are under the cardiovascular surgery
Two groups in this study are a group of patients who use albumin 5% in prime solution.
And the second group of patients who used albumin to 2% condiment in their prime solution
Main outcome variables
albumin
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180522039787N1
Registration date:2018-08-27, 1397/06/05
Registration timing:retrospective
Last update:2018-08-27, 1397/06/05
Update count:0
Registration date
2018-08-27, 1397/06/05
Registrant information
Name
Amirhosein Salehzade
Name of organization / entity
Rajaei Cardiovascular, Medical & Research Center
Country
Iran (Islamic Republic of)
Phone
+98 13 3554 5206
Email address
a.salehzade@rhc.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-03-06, 1396/12/15
Expected recruitment end date
2018-06-20, 1397/03/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Compare the effects of 5% albumin dose versus 2% in prime solution on fluid balance in heart surgery on congenital heart disease in newborn and infant
Public title
effect of albumin in pediatric surgery
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Parental satisfaction regarding participation in research project
Age 5 days to 2 years
Weight less than or equal to 10 kg
Patients candidated for open heart surgery
Congenital anomaly of the heart
Duration of cardiopulmonary bypass[ for at least one hour and maximum three hours
Exclusion criteria:
Deep hypothermia
low cardiac output
edema or ascites before surgery
Infection and inflammation known a week before surgery
emergency surgery
Not consenting parents to enter the trial
Age
From 5 days old to 2 years old
Gender
Both
Phase
3
Groups that have been masked
Participant
Care provider
Outcome assessor
Data analyser
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
In this study, a random block was used.
Random units are individual.
The randomization tool in this study is a random numbered table.
The size of each block is 5.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, after cardiac surgery, all specimens are under echocardiography to check for ascites and efusion, which the pediatric cardiologist, who is responsible for this task, is blind to the study. The respectable perfusionists and the relevant heart surgeon are also blind to the patients. Nurses also do not know how to share patients. But the main investigator who is responsible for recording data is not blind to the study.
After determining the placement of the sample in the control group or the intervention, we prepare a sample of the primer solution. Regarding the used oxygenator, the serum level used for primers is different. For each 100 cc of serum, 5 g of albumin in the intervention group and 2 g in the control group are used to reach the desired crop. It should be noted that perfusionists who prepare prime solution for the patient are blind to the study.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee at Shahid Rajaee Cardiology Hospital of Tehran
Street address
valiasr Ave. niayesh blvd. shahid rajae cardiovascular and research center
City
tehran
Province
Tehran
Postal code
6911151
Approval date
2018-02-17, 1396/11/28
Ethics committee reference number
RHC.AC.REC.1396.83
Health conditions studied
1
Description of health condition studied
congenital heart desease
ICD-10 code
Q25.0
ICD-10 code description
Patent ductus arteriosus
Primary outcomes
1
Description
albumin
Timepoint
At the beginning of the study (before the study started) - Immediately in the intensive care unit - 24 hours later in the intensive care unit
Method of measurement
Albumin Measuring Laboratory Kit
2
Description
on fluid balance
Timepoint
At the beginning of the study (before the study started) - Immediately in the intensive care unit - 24 hours later in the intensive care unit
Method of measurement
Laboratory kit measuring body electrolytes
Secondary outcomes
empty
Intervention groups
1
Description
The intervention group in this study is a patient with albumin concentration of 5% in prime solutions.First, the appropriate oxygenator is selected with the patient and is primed with a ringer serum. Corresponding to the amount of ringer serum used to reach 5% concentration of albumin in prime solution, 20% vial of albumin available in the hospital is used. The albumin has been used in 50cc vials at a concentration of 20% in the hospital. For example, if 200 cc of the ringer is used for the oxygenator prime, 10 g of albumin is added to the prime solution to achieve a 5% concentration of albumin in the patient's prime solution. Only in prime solution and once using albumin, then the process of preparing the patient and the equipment continues to proceed.
Category
Treatment - Devices
2
Description
Control group: The control group in this study is a patient with albumin concentration of 2% in prime solutions.First, the appropriate oxygenator is selected with the patient and is primed with a ringer serum. Corresponding to the amount of ringer serum used to reach 2% concentration of albumin in prime solution, 20% vial of albumin available in the hospital is used. The albumin has been used in 50cc vials at a concentration of 10% in the hospital. For example, if 200 cc of the ringer is used for the oxygenator prime, 4 g of albumin is added to the prime solution to achieve a 5% concentration of albumin in the patient's prime solution. Only in prime solution and once using albumin, then the process of preparing the patient and the equipment continues to proceed.
Category
Treatment - Devices
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Rajae Cardiovascular and Research Center
Full name of responsible person
Amirhosein Salehzade
Street address
Shahid Rajae Heart Center.Valieasr Ave
City
Tehran
Province
Tehran
Postal code
1995614331
Phone
+98 21 23921
Fax
+98 21 2204 2026
Email
a.salehzade@rhc.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shahid Rajae Cardiovascular and Research Center
Full name of responsible person
Amirhosein Salehzade
Street address
Shahid Rajae Heart Center.Valieasr Ave
City
Tehran
Province
Tehran
Postal code
1995614331
Phone
+98 21 23921
Fax
+98 21 2204 2026
Email
a.salehzade@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shahid Rajae Cardiovascular and Research 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
Shahid Rajae Cardiovascular and Research Center
Full name of responsible person
Amirhosein Salehzade
Position
Graduate Student of Perfusion
Latest degree
Bachelor
Other areas of specialty/work
Circulation Technology
Street address
Shahid Rajae Heart Center.Valieasr Ave
City
Tehran
Province
Tehran
Postal code
1995614331
Phone
+98 21 23921
Fax
+98 21 2204 2026
Email
a.salehzade@rhc.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shahid Rajae Heart Center
Full name of responsible person
Amirhosein Salehzade
Position
Graduate Student of Perfusion
Latest degree
Bachelor
Other areas of specialty/work
Circulation Technology
Street address
Shahid Rajae Heart Center.Valieasr Ave
City
Tehran
Province
Tehran
Postal code
1995614331
Phone
+98 21 23921
Fax
+98 21 2204 2026
Email
a.salehzade@rhc.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Shahid Rajae Heart Center
Full name of responsible person
Amirhosein Salehzade
Position
Graduate Student of Perfusion
Latest degree
Bachelor
Other areas of specialty/work
Circulation Technology
Street address
Shahid Rajae Heart Center.Valieasr Ave
City
Tehran
Province
Tehran
Postal code
1995614331
Phone
+98 21 23921
Fax
+98 21 2204 2026
Email
a.salehzade@rhc.ac.ir
Web page address
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
Not applicable
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
No - There is not a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available