Protocol summary

Study aim
Determining the consequences of administration of serum with lower amounts of potassium in Hospitalized children in Hazrat Masoumeh Hospital, Qom.
Design
Clinical trial with a control group with parallel groups of a blinded randomized phase 3 on 114 patients. Blocking was used for randomization.
Settings and conduct
Patients hospitalized in Hazrat Masoumeh Hospital, Qom, are included in the study and the exclusion criteria are applied. Patients are divided into two groups based on random block method. In the intervention group, dextrose serum 5% half saline does not contain potassium. In the control group, 20 meq/lit of potassium are added to their serum according to Nelson's reference A blood sample is sent to check VBG and the serum level of serum electrolytes and Bun, Cr, urine sample. Then, the potassium serum level will be checked every 12 hours to 48 hours. If it drops more than 0.5 milliequivalents compared to the initial potassium of the patient or is less than 3.5, it will be removed from the study and potassium will be added to the patient's serum.
Participants/Inclusion and exclusion criteria
Children 1-16 years admitted to the hospital, who need serum therapy, are included in the study. Exit criteria: Renal failure, metabolic diseases, gastroenteritis, Patients with heart dis. immunodeficiency, potassium serum level less than 3.5, patients with food intolerance, underlying kidney disease, age under 1 year, polyuria or anuric, drop more than 0.5 potassium after 12 hours.
Intervention groups
For children aged 1-16 years who meet the inclusion criteria, potassium-free dextrose half-saline serum is prescribed and the potassium level is checked five times at 12-hour intervals.
Main outcome variables
Serum potassium level of the first, second, third, fourth and fifth tests , Serum levels of BUN, Cr and VBG , Urinary volume

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20240513061780N1
Registration date: 2024-05-26, 1403/03/06
Registration timing: registered_while_recruiting

Last update: 2024-05-26, 1403/03/06
Update count: 0
Registration date
2024-05-26, 1403/03/06
Registrant information
Name
Saeede Asgari
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 25 3270 1548
Email address
shiao171368@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-05-19, 1403/02/30
Expected recruitment end date
2024-07-20, 1403/04/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of the consequences of potassium administration with lower amounts than the estimated amount in hospitalized children
Public title
Comparison of the consequences of potassium administration with lower amounts than the estimated amount in hospitalized children
Purpose
Prevention
Inclusion/Exclusion criteria
Inclusion criteria:
Children aged 1-16 years hospitalized
Exclusion criteria:
Renal failure, metabolic diseases, gastroenteritis - Patients with heart disease such as congenital or acquired heart diseases such as myocarditis, etc. - Immunocompromised patients including patients with congenital or acquired immune defects such as cancer. Under treatment with Corton and... - Serum potassium level less than 3/5 - Patients who have food intolerance - underlying kidney disease (tubulopathy - RTA - Barter and... - children under one year old - polyuria or anuric - In case of a drop of more than 0.5 potassium after 12 hours and compared to the initial potassium of the patient
Age
From 1 year old to 16 years old
Gender
Both
Phase
3
Groups that have been masked
  • Participant
Sample size
Target sample size: 114
More than 1 sample in each individual
Number of samples in each individual: 5
In every patient who meets the inclusion criteria, the serum potassium level will be checked five times at 12-hour intervals.
Randomization (investigator's opinion)
Randomized
Randomization description
Patients are divided into two groups using the randomized balanced block method with block sizes of 4 and 6. The random sequence is generated by the epidemiologist by running an online program at the website (https://www.sealedenvelope.com/). Allocation concealment is also guaranteed due to the use of special codes generated by the website.
Blinding (investigator's opinion)
Single blinded
Blinding description
The patients who entered the study do not know their serum electrolyte status, and the researchers and clinical caregivers identify the patients using predetermined codes.
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Qom University of Medical Sciences
Street address
Hazrat Masoumeh Hospital, Imam Street, Shahid Zainuddin Square, Qom
City
QOM
Province
Ghoum
Postal code
3713649373
Approval date
2024-01-22, 1402/11/02
Ethics committee reference number
IR.MUQ.REC.1402.225

Health conditions studied

1

Description of health condition studied
Investigating the outcome of serum with lower amounts of potassium in children
ICD-10 code
ICD-10 code description

Primary outcomes

1

Description
The percentage of potassium consumption in maintenance serum
Timepoint
Serum potassium level in the first sample and every 12 hours to 48 hours
Method of measurement
Investigation of potassium serum level by venous sampling

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: 1-16 year old children whose maintenance serum contains half saline without potassium
Category
Other

2

Description
Control group: Children 1-16 years old whose maintenance serum is half saline plus 20 milliequivalents per liter of potassium.
Category
Other

Recruitment centers

1

Recruitment center
Name of recruitment center
Hazrat Masoumeh Hospital
Full name of responsible person
Saeede Asgari
Street address
Imam Street, Shahid Zainuddin Square, Hazrat Masoumeh Hospital
City
Qom
Province
Ghoum
Postal code
3713649373
Phone
+98 25 3162 5224
Email
shiao171368@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Ghoum University of Medical Sciences
Full name of responsible person
Dr. Rahim Ali
Street address
Qom, Shahid Zainuddin Square, Hazrat Masoumeh Hospital
City
Qom
Province
Ghoum
Postal code
3713649373
Phone
+98 25 3162 5224
Email
shiao171368@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Ghoum 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

Person responsible for general inquiries

Contact
Name of organization / entity
Ghoum University of Medical Sciences
Full name of responsible person
Saeede Asgari
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Pediatrics
Street address
Qom, Shahid Zainuddin Square, Hazrat Masoumeh Hospital
City
Qom
Province
Ghoum
Postal code
3713649373
Phone
+98 25 3162 5224
Email
shiao171368@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Ghoum University of Medical Sciences
Full name of responsible person
Saeede Asgari
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Pediatrics
Street address
Qom, Shahid Zainuddin Square, Hazrat Masoumeh Hospital
City
Qom
Province
Ghoum
Postal code
3713649373
Phone
+98 25 3162 5224
Email
shiao171368@gmail.com

Person responsible for updating data

Contact
Name of organization / entity
Ghoum University of Medical Sciences
Full name of responsible person
Saeede Asgari
Position
Resident
Latest degree
Medical doctor
Other areas of specialty/work
Pediatrics
Street address
Qom, Shahid Zainuddin Square, Hazrat Masoumeh Hospital
City
Qom
Province
Ghoum
Postal code
3713649373
Phone
+98 25 3162 5224
Email
shiao171368@gmail.com

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
Yes - There is a plan to make this available
Analytic Code
Yes - There is 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
All data is potentially shareable after de-identifying individuals
When the data will become available and for how long
The access period starts from January 2024
To whom data/document is available
It will be available only to researchers working in academic and scientific institutions
Under which criteria data/document could be used
A letter to the Vice-Chancellor of Medical Sciences Research, Qom
From where data/document is obtainable
saeede asgari
What processes are involved for a request to access data/document
One Month
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