Investigating the agreement of hypomagnesemia diagnosis based on three methods of serum , urine and red blood cells magnesium in intensive care unit : prospective trial
Investigating the agreement of hypomagnesemia diagnosis based on three methods of serum, urine and red blood cells magnesium
Design
The clinical trial is prospective, phase 2 is designed on 25 patients, No randomization and no blinding, performed on patients located in the ICU of Bu Ali Hospital.
Settings and conduct
Patients admitted to the intensive care unit of Bu Ali Hospital will be included in the study if they are eligible, and the study will be conducted with an intervention group and no control group, without blinding and randomization. At first, the serum magnesium and red blood cells of these patients will be evaluated by taking blood from them, then magnesium sulfate will be administered intravenously according to the study protocol; From the beginning of the injection, the 24-hour urine of these patients will be collected and their urinary magnesium will be evaluated.
Participants/Inclusion and exclusion criteria
Age over 18 years; stay in the intensive care unit for more than 72 hours; no hypermagnesemia of the patient; no magnesium supplements in the past 72 hours; no pregnancy and breastfeeding; no kidney dysfunction (serum creatinine more than 1.5 ml grams per dL); absence of heart rate less than 60 beats per minute; absence of severe metabolic disorders; patient not being treated with diuretic drugs; not having blood coagulation disorder
Intervention groups
Intervention group: determining the amount of serum magnesium and red blood cells, then administering 7.5 grams of magnesium sulfate over 8 hours at a rate of 125 ml per hour in 1000 cc of isotonic saline intravenously and collecting urine 24 hours after the start of the injection and measuring the amount of magnesium excreted.
The study has no control group
Main outcome variables
Investigation of hypomagnesemia in intensive care unit patients
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20231220060484N3
Registration date:2024-04-18, 1403/01/30
Registration timing:prospective
Last update:2024-04-18, 1403/01/30
Update count:0
Registration date
2024-04-18, 1403/01/30
Registrant information
Name
Amirhossein Ghanbarzamani
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 4406 9924
Email address
amirh.ghzamani@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-05-09, 1403/02/20
Expected recruitment end date
2024-07-10, 1403/04/20
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Investigating the agreement of hypomagnesemia diagnosis based on three methods of serum , urine and red blood cells magnesium in intensive care unit : prospective trial
Public title
Investigating the agreement of hypomagnesemia diagnosis based on three methods of serum , urine and red blood cells magnesium
Purpose
Supportive
Inclusion/Exclusion criteria
Inclusion criteria:
At least 72 hours of placement in ICU
The patient's lack of hypermagnesium
Not receiving magnesium supplement at least in the past 72 hours
Absence of pregnancy and breastfeeding
Exclusion criteria:
The presence of kidney dysfunction (serum creatinine above 1.5 mg per dL)
Heart rate less than 60 per minute
Severe metabolic disorder
The patient is treated with diuretic drugs
Coagulopathy
Age
From 18 years old
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size:
25
Randomization (investigator's opinion)
N/A
Randomization description
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Single
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
The Islamic Azad University, Tehran Medical Branch
Street address
Danesh Dead End, Attari Moghadam Ave, Khaghani Ave, Dr Shariati Ave, Tehran
City
Tehran
Province
Tehran
Postal code
1936893813
Approval date
2023-05-30, 1402/03/09
Ethics committee reference number
IR.IAU.PS.REC.1402.124
Health conditions studied
1
Description of health condition studied
Serum Magnesium
ICD-10 code
R79.0
ICD-10 code description
Abnormal level of blood mineral
2
Description of health condition studied
Red Blood Cell Magnesium
ICD-10 code
R79.0
ICD-10 code description
Abnormal level of blood mineral
3
Description of health condition studied
Urine Magnesium
ICD-10 code
R79.0
ICD-10 code description
Abnormal level of blood mineral
Primary outcomes
1
Description
Investigation of serum magnesium
Timepoint
At the beginning of the study
Method of measurement
End point colorimetric
2
Description
Investigation of red blood cell magnesium
Timepoint
At the beginning of the study
Method of measurement
Using the device ICP-OES
3
Description
Investigation of urine magnesium
Timepoint
At the end of collecting 24 hour urine
Method of measurement
By using the method MLT
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: 7.5 grams of magnesium sulfate in 1000 cc of isotonic saline during 8 hours and at a rate of 125 cc per hour as intravenous injection
Category
Prevention
Recruitment centers
1
Recruitment center
Name of recruitment center
Bu Ali Hospital
Full name of responsible person
Nastaran Nazarzade
Street address
Damavand Ave, Emam Hossein Sq, Tehran
City
Tehran
Province
Tehran
Postal code
1711734365
Phone
+98 21 3334 8036
Email
itsnastrn@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Islamic Azad University
Full name of responsible person
Dr Seyedeh Zahra Mousavi
Street address
Yakhchal Ave
City
Tehran
Province
Tehran
Postal code
1941933111
Phone
+98 21 2264 0052
Email
mosavi50@yahoo.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Islamic Azad University
Proportion provided by this source
1
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
Islamic Azad University
Full name of responsible person
Amirhossein Ghanbarzamani
Position
Clinical pharmacologist
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
No 99, Yakhchal St, Dr Shariati St, Tehran
City
Tehran
Province
Tehran
Postal code
1941933111
Phone
+98 21 2264 0056
Email
amirh.ghzamani@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Amirhossein ghanbarzamani
Position
Clinical pharmacologist
Latest degree
Ph.D.
Other areas of specialty/work
Medical Pharmacy
Street address
No 99, Yakhchal St, Dr Shariati St
City
Tehran
Province
Tehran
Postal code
1941933111
Phone
+98 21 2264 0056
Email
amirh.ghzamani@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Islamic Azad University
Full name of responsible person
Nastaran Nazarzade
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Medical Pharmacy
Street address
No 99, Yakhchal St, Dr Shariati St
City
Tehran
Province
Tehran
Postal code
1936893813
Phone
+98 915 661 7224
Email
itsnastrn@gmail.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 plan for publishing the protocol of study because it is accessible in IRCT
Study Protocol
No - There is not a plan to make this available
Statistical Analysis Plan
No - There is not 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
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
All data are shareable after publishing
When the data will become available and for how long
Start the access period 6 months after publishing
To whom data/document is available
All researchers
Under which criteria data/document could be used
for used in clinical practice and future meta-analysis
From where data/document is obtainable
Nastaran Nazarzade - itsnastrn@gmail.com
What processes are involved for a request to access data/document
Sending email to Nastaran Nazarzade
itsnastrn@gmail.com