Evaluation of the effect of maintenance serum with the amount of sodium at the limit of isotonic saline on sodium level, blood pressure and acidosis in PICU patients of Tehran Bahrami Children's Hospital
Determination of sodium level, blood pressure and acidosis in patients receiving serum with sodium level equal to isotonic saline
Design
This double-blind clinical trial study was conducted in the PICU department of Bahrami Children's Hospital in Tehran in 1401. 90 eligible children were admitted to the PICU department and were assigned to two normal and half-saline groups one by one and based on the Block Random Allocation software with variable sizes multiples of 2.
Settings and conduct
When a patient is admitted to the pediatric intensive care unit, the nurse informs the investigator. He/she chooses one pocket if the patient is recruited. The investigator evaluates the variables from sheets completed by the caregiver team. Uncoding is done after data collection and analysis.
Participants/Inclusion and exclusion criteria
It includes children between the ages of 3 months and 18 years who are hospitalized and need intravenous serum. And the exclusion conditions include kidney patients and electrolyte disorders.
Intervention groups
The intervention group receives normal saline and the control one receives half saline. The fluid volume and rate are calculated based on weight and are the same in both groups. No other interventions were undertaken on other fluid requirements, drugs, etc.
Main outcome variables
ُBlood Sodium level; blood pressure; blood acidosis and bicarbonate
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230414057904N1
Registration date:2024-01-10, 1402/10/20
Registration timing:retrospective
Last update:2024-01-10, 1402/10/20
Update count:0
Registration date
2024-01-10, 1402/10/20
Registrant information
Name
Faezeh Jahanshahi
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 2244 2920
Email address
faezehjahanshahi3@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2022-03-25, 1401/01/05
Expected recruitment end date
2023-02-04, 1401/11/15
Actual recruitment start date
2022-03-25, 1401/01/05
Actual recruitment end date
2023-02-04, 1401/11/15
Trial completion date
2023-02-07, 1401/11/18
Scientific title
Evaluation of the effect of maintenance serum with the amount of sodium at the limit of isotonic saline on sodium level, blood pressure and acidosis in PICU patients of Tehran Bahrami Children's Hospital
Public title
Evaluation of the effect of maintenance serum with the amount of sodium at the limit of isotonic saline on sodium level, blood pressure and acidosis in admitted patients.
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age between 3 months and 18 years
Need for injectable serum
Exclusion criteria:
Sodium level below 130 mmol/L
Sodium level above 150 mmol/L
Having diabetes insipidus
Diabetic ketoacidosis
Kidney disease requiring dialysis
Suffering from the disease of high sodium urinary excretion(Addison's disease, congenital adrenal hyperplasia, Barrett's syndrome)
Patients before or after neurosurgery
Require chemotherapy hydration
Severe liver disease
Patients who are likely to receive maintenance serum for less than 6 hours
Age
From 3 months old to 18 years old
Gender
Both
Phase
N/A
Groups that have been masked
Participant
Investigator
Outcome assessor
Data analyser
Data and Safety Monitoring Board
Sample size
Target sample size:
90
Actual sample size reached:
88
Randomization (investigator's opinion)
Randomized
Randomization description
Patients are assigned to normal and half-saline groups, one by one, and based on the Block Random Allocation software with variable sizes multiples of 2. Randomization in two strata will be done separately. We write every code on paper and put it in a pocket which its content cannot be read. Every code is allocated to every patient who is included until the end.
Blinding (investigator's opinion)
Double blinded
Blinding description
The legal guardian and/or the patient is aware of participating in the study but, does not know the fluid types. The care provider and the nurse who are not a research member know the fluid type but, the investigator, outcome assessor, and data analyzer do not.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Mohammad Eftekhari
Street address
Keshavarz Blvd, Tehran university of medical science, school of medicine, Tehran, Iran.
City
Tehran
Province
Tehran
Postal code
+98-21
Approval date
2021-10-11, 1400/07/19
Ethics committee reference number
IR.TUMS.CHMC.REC.1400.145
Health conditions studied
1
Description of health condition studied
Hypertension
ICD-10 code
I15.8
ICD-10 code description
Other secondary hypertension
2
Description of health condition studied
Influence of the maintenance fluid (normal vs. half saline) on blood sodium level
ICD-10 code
E87.1
ICD-10 code description
Hypo-osmolality and hyponatremia
Primary outcomes
1
Description
ُBlood Sodium level
Timepoint
6,24,48, and 72 hours
Method of measurement
Blood lab test, with the same kit for all patients.
2
Description
Blood pressure
Timepoint
Every hour
Method of measurement
Non-invasive blood pressure monitoring, with appropriate cuff size
3
Description
Blood PH
Timepoint
hours 6، 24، 48 , 72
Method of measurement
Blood lab test, with the same kit for all patients.
4
Description
Blood bicarbonate level
Timepoint
hours 6، 24، 48 , 72
Method of measurement
Blood lab test, with the same kit for all patients.
Secondary outcomes
empty
Intervention groups
1
Description
Normal saline maintenance fluid, 4cc/kg.h for first 10kg, 2cc/kg.h for second 10kg, and 2cc/kg.h for third and more 10kg. There is no specific brand to use and it will depend on Bahrami hospital's drugstore. Training sessions is not in our method. Administration time will depend on ICU admission period. The chemical formula is obvious according to drug's name and it is NaCl 0.9%.
Category
Treatment - Other
2
Description
Control group: Half saline maintenance fluid, 4cc/kg.h for first 10kg, 2cc/kg.h for second 10kg, and 2cc/kg.h for third and more 10kg. There is no specific brand to use and it will depend on Bahrami hospital's drugstore. Training sessions is not in our method. Administration time will depend on ICU admission period. The chemical formula is obvious according to drug's name and it is NaCl 0.45%.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Bahrami Children's Hospital
Full name of responsible person
Faezeh Jahanshahi
Street address
Damavand St., Kiaei St., Ansar Al Hossein St
City
Tehran
Province
Tehran
Postal code
1641744991
Phone
+98 21 7301 3000
Email
faezehjahanshahi3@gmail.com
Web page address
https://bahrami.tums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Vice Chancellor for Research
Street address
Enghelab st, Qods st, Poursina st, school of medicine
City
Tehran
Province
Tehran
Postal code
1461884513
Phone
+98 21 6640 5357
Email
deanmed@tums.ac.ir
Web page address
https://Bahrami.tums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
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
Yes - There is a plan to make this available
Analytic Code
Not applicable
Data Dictionary
Not applicable
Title and more details about the data/document
The information related to the questionnaire, which includes the individual characteristics of the participants and the variables and outcomes, will be shared.
When the data will become available and for how long
The access period starts from 1402
To whom data/document is available
Study documents will be accessible to study reviewers and researchers of academic and scientific centers.بر
Under which criteria data/document could be used
The study documents will be accessible to the reviewers of the project for the purpose of verification without conditions. It will be useful for others (researchers working in academic and scientific institutions) in order to improve the quality of treatment in childrens fild with respect to trustworthiness standards.
From where data/document is obtainable
Applicants can request the study documents from the researcher through the postal address and e-mail, and they can also interact in person.
Email : faezehjahanshahi3@gmail.com
Postal code : 1955673933
Address : No. 29,. Sabouri St,. Alborz St., Naft Town,. Artesh Sharq Highway., Imam Ali Highway., Tehran
What processes are involved for a request to access data/document
The study documents will be sent to the email address after the request which should be from an ethical committee or reference and with the supervisor professor's permission.