Comparative study of lactate ringer and normal saline administration on serum electrolytes in children undergoing cardiac angiography at the Pediatric Medical Center
Comparative study of lactate ringer and normal saline administration on serum electrolytes in children undergoing cardiac angiography at the Pediatric Medical Center
Design
This study will be conducted as a randomized, double-blind (outcome evaluator and statistical analyzer), phase 3 clinical trial with parallel groups, on 40 eligible patients. The table of random numbers provided by sealedenvelope.com will be used for randomization.
Settings and conduct
This study will be conducted on eligible patients at Children's Medical Center, Tehran, Iran. After receiving anesthesia, the patients will be randomly divided into one of two study groups and will receive the relevant intervention. The outcome evaluator and the statistical analyst will be unaware of the type of groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
The age of the patient is between 1 and 10 years old;
The patient is a candidate for electrocardiographic angiography;
The patient's parents give informed and free written consent for their child's participation in the study.
Exclusion criteria:
Being dehydrated at the time of enrollment the study;
Having electrolyte abnormalities at the time of enrollment the study:
Massive bleeding during the angiography.
Intervention groups
Group 1) Administration of Normal saline as maintenance serum during angiography, with volume calculated by Halliday's formula
Group 2) Administration of Lactated ringer as maintenance serum during angiography, with volume calculated by Halliday's formula
Main outcome variables
Intraoperative arterial blood PH
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20151221025641N10
Registration date:2024-05-31, 1403/03/11
Registration timing:prospective
Last update:2024-05-31, 1403/03/11
Update count:0
Registration date
2024-05-31, 1403/03/11
Registrant information
Name
Parisa Kianpour
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2660 2854
Email address
pk.pioneer1@yahoo.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-06-04, 1403/03/15
Expected recruitment end date
2024-12-05, 1403/09/15
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparative study of lactate ringer and normal saline administration on serum electrolytes in children undergoing cardiac angiography at the Pediatric Medical Center
Public title
Comparative study of lactate ringer and normal saline administration on serum electrolytes in children undergoing cardiac angiography at the Pediatric Medical Center
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
The age of the patient is between 1 and 10 years old;
The patient is a candidate for electrocardiographic angiography;
The patient's parents give informed and free written consent for their child's participation in the study.
Exclusion criteria:
Being dehydrated at the time of enrollment the study;
Having electrolyte abnormalities at the time of enrollment the study;
Massive bleeding during the angiography.
Age
From 1 year old to 10 years old
Gender
Both
Phase
3
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization will be done by random number table method through blocks of 4 created by referring to www.sealedenvelope.com.
In this method, 40 eligible patients will be randomly divided into 10 blocks including 4 patients; Then, each of the 4 patients in the block will be randomly assigned to one of the 2 study groups based on the sequence provided by the site, so that 20 patients will be assigned to each group.
Blinding (investigator's opinion)
Double blinded
Blinding description
In this study, the outcome evaluator and the statistical analyzer will be unaware of the type of intervention. A trained staff (anesthesiologist) who is not a member of the research group will evaluate the intended outcomes after the intervention is completed by the anesthesiologist.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Tehran University of Medical Sciences
Street address
Central building, Ghods St., Keshavarz Blvd
City
Tehran
Province
Tehran
Postal code
1913914435
Approval date
2024-02-27, 1402/12/08
Ethics committee reference number
IR.TUMS.CHMC.REC.1400.291
Health conditions studied
1
Description of health condition studied
Cardiac angiography
ICD-10 code
I99
ICD-10 code description
Other and unspecified disorders of circulatory system
Primary outcomes
1
Description
Intraoperative arterial blood PH
Timepoint
Beginning and end of angiography
Method of measurement
Blood test
Secondary outcomes
1
Description
Serum sodium level
Timepoint
Beginning and end of angiography
Method of measurement
Blood test
2
Description
Serum potassium level
Timepoint
Beginning and end of angiography
Method of measurement
Blood test
3
Description
Serum calcium level
Timepoint
Beginning and end of angiography
Method of measurement
Blood test
4
Description
Serum glucose level
Timepoint
Beginning and end of angiography
Method of measurement
Blood test
Intervention groups
1
Description
Intervention group: Normal saline serum as maintenance serum during angiography, with prescribed volume based on Halliday's formula
Category
Treatment - Drugs
2
Description
Control group: Lactated ringer serum as maintenance serum during angiography, with prescribed volume based on Halliday's formula
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Children' Medical Center
Full name of responsible person
Bita Malekianzadeh
Street address
Children's Medical Center, Dr. Mohammad Gharib St.,Keshavarz Blvd.
City
Tehran
Province
Tehran
Postal code
1419733151
Phone
+98 21 6147 9000
Email
bmalekianzadeh@sina.tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Ali Akbari Sari
Street address
Central building, Ghods Ave., Keshavarz Blvd.
City
Tehran
Province
Tehran
Postal code
1913914435
Phone
+98 21 8163 1000
Email
vcr@sina.tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical Sciences
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
2
Sponsor
Name of organization / entity
Anesthesiology, critical care and pain management research center
Full name of responsible person
Farhad Etezadi
Street address
Sina hospital, Hasan abad sq., Imam khomeini Ave.
City
Tehran
Province
Tehran
Postal code
4691111367
Phone
+98 21 6312 0000
Email
accpm.rc.tums@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Anesthesiology, critical care and pain management 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
Tehran University of Medical Sciences
Full name of responsible person
Bita Malekianzadeh
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Children's Medical Center, Dr. Mohammad Gharib St.,Keshavarz Blvd.
City
Tehran
Province
Tehran
Postal code
1419733151
Phone
+98 21 6147 9000
Email
bmalekianzadeh@sina.tums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Bita Malekianzadeh
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Children's Medical Center, Dr. Mohammad Gharib St.,Keshavarz Blvd.
City
Tehran
Province
Tehran
Postal code
1419733151
Phone
+98 21 6147 9000
Email
bmalekianzadeh@sina.tums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Bita Malekianzadeh
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Anesthesiology
Street address
Children's Medical Center, Dr. Mohammad Gharib St.,Keshavarz Blvd.
City
Tehran
Province
Tehran
Postal code
1419733151
Phone
+98 21 6147 9000
Email
bmalekianzadeh@sina.tums.ac.ir
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