Comparing the mean arterial blood parameters, pro-calcitonin, mechanical ventilation, pulmonary compliance and respiratory index in patients with zero-balanced ultrafiltration (Z_BUF) prime compared to control group.
Design
This is a randomized controlled clinical trial with parallel design. We apply balanced block randomization method (block of four) for randomization. Randomization sequence will be give to a person out of the research team in order to perform concealment.
Settings and conduct
This is a single center open-labeled study. The study conducted in cardiac surgery operation rooms and post-op ICUs in Rajaie Heart Center, Tehran, Iran.
Participants/Inclusion and exclusion criteria
Inclusion Criteria: pregnancy duration equal or more than 37 weeks Parental consent weight under 10 kg open heart surgery no other major congenital anomaly affected post-op recovery No previous sternotomy
Exclusion criteria: cardiac arrest during the operation using defibrillator during the operation aortic clamp time less than 30 minutes
Intervention groups
Intervention group: standard ultrafiltration AND zero-balanced ultrafiltration on the prime solution during cardiopulmonary bypass pump (CPB)
Control group: standard ultrafiltration on the prime solution during cardiopulmonary bypass pump (CPB)
Main outcome variables
mean level of serum procalcitonin; Respiratory Index; pulmonary compliance
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20180110038301N1
Registration date:2018-05-21, 1397/02/31
Registration timing:retrospective
Last update:2018-05-21, 1397/02/31
Update count:0
Registration date
2018-05-21, 1397/02/31
Registrant information
Name
sana niknam
Name of organization / entity
Shahid rajaie cardiovaschular medical & researchcenter
Country
Iran (Islamic Republic of)
Phone
+98 21 2392 2424
Email address
sananiknam@rhc.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2017-09-06, 1396/06/15
Expected recruitment end date
2018-02-19, 1396/11/30
Actual recruitment start date
2017-09-06, 1396/06/15
Actual recruitment end date
2018-02-19, 1396/11/30
Trial completion date
empty
Scientific title
Effect of zero-balanced ultrafiltration of priming blood on pro-calcitonin and respiratory function in the infants undergoing cardiopulmonary bypass
Public title
Effect of prime ultrafiltration on pro-calcitonin and respiratory function in the infants undergoing cardiopulmonary bypass
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
pregnancy duration equal or more than 37 weeks
Parental consent
weight under 10 kg
open heart surgery
no other major congenital anomaly affected post-op recovery
No previous sternotomy
Exclusion criteria:
cardiac arrest during the operation
using defibrillator during the operation
aortic clamp time less than 30 minutes
Age
To 18 months old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
60
More than 1 sample in each individual
Number of samples in each individual:
4
blood biochemistry and procalcitonin,respiratory function
Actual sample size reached:
60
More than 1 sample in each individual
Actual sample size in each individual:
4
blood biochemistry and procalcitonin,respiratory function
Randomization (investigator's opinion)
Randomized
Randomization description
We apply balanced block randomization method (block of four) for randomization. Randomization sequence will be give to a person out of the research team in order to perform concealment.
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 Rajaie cardiovascular medical and research center
Street address
Valiasr Ave Niayesh Intersection
City
Tehran
Province
Tehran
Postal code
1995614331
Approval date
2017-10-14, 1396/07/22
Ethics committee reference number
RHC.AC.IR.REC.1396.45
Health conditions studied
1
Description of health condition studied
infants required cardiac surgery with cardiopulmonary bypass pump (due to congenital anomalies)
ICD-10 code
Q24
ICD-10 code description
Other congenital malformations of heart
Primary outcomes
1
Description
mean level of serum procalcitonin
Timepoint
first and 24 hour after admission to ICU
Method of measurement
Electro-chemiluminescence immunoassay (ECLIA) method via cobas, Roshe
2
Description
Respiratory Index
Timepoint
pre-operative after induction of anesthesia, at the end of operation and 2 hours after ICU admission
Method of measurement
Ventilator output
3
Description
pulmonary compliance
Timepoint
pre-operative after induction of anesthesia, at the end of operation and 2 hours after ICU admission
Method of measurement
Ventilator output
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: standard ultrafiltration AND zero-balanced ultrafiltration on the prime solution during cardiopulmonary bypass pump (CPB)
Category
Treatment - Other
2
Description
Control group: standard ultrafiltration on the prime solution during cardiopulmonary bypass pump (CPB)
Category
Treatment - Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Rajaie Cardiovascular Medical and Research Center
Full name of responsible person
Maziar Gholampour
Street address
Valiasr Ave Niayesh Intersection
City
Tehran
Province
Tehran
Postal code
1995614331
Phone
+98 21 23921
Email
sananiknam@rhc.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Rajaie Cardiovascular Medical and Research Center
Full name of responsible person
Maziar Gholampour
Street address
Valiasr Ave Niayesh Intersection
City
Tehran
Province
Tehran
Postal code
1995614331
Phone
+98 21 23921
Email
sananiknam@rhc.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Rajaie Cardiovascular Medical 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
Rajaie Cardiovascular Medical and Research Center
Full name of responsible person
Sana Niknam
Position
Student
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Valiasr Ave Niayesh Intersection
City
Tehran
Province
Tehran
Postal code
1995614331
Phone
+98 21 23921
Email
sananiknam@rhc.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Rajaie Cardiovascular Medical and Research Center
Full name of responsible person
Maziar Gholampour
Position
Professor
Latest degree
Subspecialist
Other areas of specialty/work
cardiac surgery
Street address
Valiasr Ave Niayesh Intersection
City
Tehran
Province
Tehran
Postal code
1995614331
Phone
+98 21 23921
Email
sananiknam@rhc.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Rajaie Cardiovascular Medical and Research Center
Full name of responsible person
Sana Niknam
Position
Student
Latest degree
Master
Other areas of specialty/work
Nursery
Street address
Valiasr Ave Niayesh Intersection
City
Tehran
Province
Tehran
Postal code
1995614331
Phone
+98 21 23921
Email
sananiknam@rhc.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
No - There is not a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
Study protocol and De-identified Individual Participant Data Set (IPD) will be shared.
When the data will become available and for how long
Data will be available after publishing the relevant articles.
To whom data/document is available
All the researches in the biomedical field can propose their request about accessing data.
Under which criteria data/document could be used
For using the study data, it is necessary to make an agreement/collaboration contract between the applicants and primary investigator (PI).
From where data/document is obtainable
The applicants should proposed their request to the PI via the email.
What processes are involved for a request to access data/document
Only the applications received via email will be considered and replied. For continuation , PI will contact the applicant's mobile.