The Effect of Calcium Gluconate Injection on Hemodynamic Variables During Cardiopulmonary Bypass and Clinical Outcome in infants Under Open Heart Surgery
Determining and comparing the mean
(Systolic and diastolic blood pressure,
Arterial blood pressure,
Consumption of inotropes,
Heart rate,
Arterial blood gas levels,
Cardiac output fraction)
And the frequency of postoperative blood transfusions in the intervention and control groups
Design
This study is a randomized controlled clinical trial with single-blind (patient unaware of the intervention). Patients were divided into 2 groups of 30 by random randomization (Block randomization) with size 6.
Settings and conduct
This intervention will be performed in Shahid Rajaei Cardiovascular Educational, Research and Treatment Center in 1400 in children. The study population included all infants who were candidates for open heart surgery weighing up to 10 kg.
Participants/Inclusion and exclusion criteria
1) Parents' consent to participate in the research project
2) Sick infants up to 10 kg candidate for open heart surgery
3) Normal and lower ionized calcium during cardiopulmonary bypass
4) Absence of any metabolic and systemic diseases that affect the level of calcium gluconate
5) Do not take digoxin before surgery by the patient
6) The patient does not have hypophosphatemia
7) Patients who do not undergo reoperation or emergency surgery
Intervention groups
The study population included all sick children who were candidates for open heart surgery weighing up to 10 kg.
In the first group, intravenous injection of calcium gluconate at a rate of 100 mg / kg at a rate of 25 mg / kg per minute up to a maximum of 1 gram, 20 minutes after opening the aortic clamp and the second group will be evaluated as a control.
Main outcome variables
Correction of hemodynamic variables and improvement of cardiac function in the intensive care unit
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20210316050726N1
Registration date:2021-09-06, 1400/06/15
Registration timing:retrospective
Last update:2021-09-06, 1400/06/15
Update count:0
Registration date
2021-09-06, 1400/06/15
Registrant information
Name
Saeed Rajabzade zaree
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2610 2319
Email address
saeed.rajabzade@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2021-08-05, 1400/05/14
Expected recruitment end date
2021-09-05, 1400/06/14
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The Effect of Calcium Gluconate Injection on Hemodynamic Variables During Cardiopulmonary Bypass and Clinical Outcome in infants Under Open Heart Surgery
Public title
The Effect of Calcium Gluconate Injection on Hemodynamic Variables
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
1) Parents' consent to participate in the research project
2) infants up to 10 kg candidate for open heart surgery
3) Normal and lower ionized calcium during cardiopulmonary bypass (1.2 to 1.38 mmol / lit)
4) Absence of any metabolic and systemic diseases that affect the level of calcium gluconate
5) Do not take digoxin before surgery by the patient
6) The patient does not have hypophosphatemia
7) Patients who do not undergo reoperation or emergency surgery
Exclusion criteria:
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
Participant
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Infants of candidates for open heart surgery were divided into 6 groups (10 blocks of 6) permuted block randomization using create a randomization list software into two groups of 30 people.
Blinding (investigator's opinion)
Single blinded
Blinding description
This study is a randomized controlled clinical trial with a single blind (patient not knowing about the intervention) and after obtaining informed consent from the patient's parents and observing the inclusion cases, the patient is anesthetized due to surgery and intervention.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics Committee of Shahid Rajaei Cardiovascular University
Street address
Shaheed Rajaie Cardiovascular Medical and Research Center Valiasr Ave Niayesh Intersection Tehran Iran
City
Tehran
Province
Tehran
Postal code
1995614331
Approval date
2021-08-03, 1400/05/12
Ethics committee reference number
IR.RHC.REC.1400.042
Health conditions studied
1
Description of health condition studied
Cyanotic congenital heart disease
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
mid artrial pressure
Timepoint
Researcher at intervals before induction of anesthesia, after induction of anesthesia, during cardiopulmonary bypass, during warm-up, after opening of aortic clamp, after calcium injection, after termination of cardiopulmonary bypass, upon entering the ICU 2, 4, 6 and 8 hours after entering the ICU will be extracted and collected through the records and test sheets of the studied patients.
Method of measurement
Based on the patient's cardiovascular monitor
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: children are candidates for open heart surgery weighing up to 10 kg. In this group, intravenous injection of calcium gluconate at a rate of 100 mg / kg at a rate of 25 mg / kg per minute up to a maximum of 1 g was performed 20 minutes after opening the aortic clamp.
Category
Treatment - Drugs
2
Description
Control group: children are candidates for open heart surgery weighing up to 10 kg
Category
Other
Recruitment centers
1
Recruitment center
Name of recruitment center
Shahid Rajaei Cardiovascular Hospital
Full name of responsible person
saeed rajabzade zaree
Street address
Shahid Rajaei Cardiovascular Training, Research and Treatment Center، Vali Asr St، Tehran
City
Tehran
Province
Tehran
Postal code
1995614331
Phone
+98 21 23921
Email
saeed.rajabzade@yahoo.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
saeed rajabzade zaree
Street address
Shaheed Rajaie Cardiovascular Medical and Research Center Valiasr Ave Niayesh Intersection Tehran Iran
City
Tehran
Province
Tehran
Postal code
1995614331
Phone
+98 21 23921
Email
saeed.rajabzade@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Iran University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Private
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Persons
Person responsible for general inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
majid maleki
Position
specialist
Latest degree
Subspecialist
Other areas of specialty/work
Cardiology
Street address
Shaheed Rajaie Cardiovascular Medical and Research Center Valiasr Ave Niayesh Intersection Tehran Iran
City
Tehran
Province
Tehran
Postal code
1995614331
Phone
+98 21 23921
Email
saeed.rajabzade@yahoo.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
saeed rajabzade zaree
Position
Masters student
Latest degree
A Level or less
Other areas of specialty/work
Nursery
Street address
Shaheed Rajaie Cardiovascular Medical and Research Center Valiasr Ave Niayesh Intersection Tehran Iran
City
Tehran
Province
Tehran
Postal code
1995614331
Phone
+98 21 23921
Email
saeed.rajabzade@yahoo.com
Person responsible for updating data
Contact
Name of organization / entity
Iran University of Medical Sciences
Full name of responsible person
saeed rajabzade zaree
Position
Masters student
Latest degree
A Level or less
Other areas of specialty/work
Nursery
Street address
Shaheed Rajaie Cardiovascular Medical and Research Center Valiasr Ave Niayesh Intersection Tehran Iran
City
Tehran
Province
Tehran
Postal code
1995614331
Phone
+98 21 23921
Email
saeed.rajabzade@yahoo.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
There is no more information
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
No - There is not 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