Protocol summary

Study aim
Investigating the hypomagnesemia treatment protocol in patients hospitalized in ICU and comparing the efficacy of two methods of continuous infusion and intermitent infusion.
Design
The randomized clinical trial , non-blind, double-arm and parallel. After confirming hypomagnesemia using the magnesium challenge test, patients will be divided into two groups using the randomization method through permuted blocks of 6 created by the software. This is a pilot study and will be conducted on 30 patients (15 patients in each group).
Settings and conduct
Patients hospitalized in the ICU of Sinai Hospital, if meet the inclusion criteria, magnesium challenge test is first performed to ensure the identification of hypomagnesemia (If the patient has magnesium deficiency, magnesium retention is more than 50%.). patients divided using the randomization method through blocks of 6; one group received magnesium sulfate for 24hour continuous infusion for 3 days, and other received magnesium sulfate in the form of a 4-hour short infusion for 3 days. washing out in fourth day, then a magnesium challenge test is performed and 24-hour urine is collected. Retention of magnesium is more than 50%, considered no treatment.
Participants/Inclusion and exclusion criteria
patients age over 18 years, who have been hospitalized for less than 96 hours in the ICU and filled out written consent, will be included. If the serum concentration of magnesium is higher than 4 mg/dl, CKD , the 2nd and 3rd degrees heart block, muscle weakness , refractory shockو survival is less than 48 hours, will be excluded
Intervention groups
the first group of received magnesium sulfate as a continuous infusion over 24 hours and for 3 days and the second group receive magnesium sulfate as a 4-hour short infusion for 3 days.
Main outcome variables
Investigating the hypomagnesemia treatment protocol in patients hospitalized in ICU

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200322046833N4
Registration date: 2024-01-05, 1402/10/15
Registration timing: prospective

Last update: 2024-01-05, 1402/10/15
Update count: 0
Registration date
2024-01-05, 1402/10/15
Registrant information
Name
Farhad Najmeddin
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 21 6695 4709
Email address
f-najmeddin@sina.tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2024-01-21, 1402/11/01
Expected recruitment end date
2024-09-22, 1403/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison of two methods of administering magnesium through continuous infusion (۲۴ hours) and short-term infusion (۴ hours) in the correction of hypomagnesemia in patients admitted to the ICU of Sina Hospital: a clinical pilot study
Public title
Comparison of two methods of administering magnesium through continuous infusion (۲۴ hours) and short-term infusion (۴ hours) in the correction of hypomagnesemia
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Hypomagnesemia patients hospitalized in the intensive care unit Less than 96 hours have passed since ICU admission. written consent to enter the study
Exclusion criteria:
Magnesium serum concentration higher than 4 mg/dl Stage IV, V CKD based on the Cockcroft-Gault formula heart rate less than 50 times per minute, 2nd and 3rd degree heart block receiving a high dose of furosemide (more than 3 mg/hr) The need to receive magnesium outside the protocol History of muscle weakness disease (MS, Guillain-Barre, botulism, myasthenia gravis) Refractory shock (EP و NEP > ۳۰ mcg/min ) survival less than 48 hours Patients with AKI massive blood transfusion unable to take a urine sample for any reason​
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 30
Randomization (investigator's opinion)
Randomized
Randomization description
Using the randomization method, patients are divided into two groups 1:1 ratio, by the randomization table. The permuted block randomization table is generated electronically in block sizes of six. In order to randomize, 5 blocks with 6 column are created, the number of each group in the blocks is equal and randomly, if the patients have the conditions to enter the study, they will be placed in one of the groups in the order of the rows of the block.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics Committee of Sina Hospital - Tehran University of Medical Sciences
Street address
Sina Hospital, Imam Khomeini St, Hasanabad Square, Tehran, Iran
City
Tehran
Province
Tehran
Postal code
1136746911
Approval date
2023-11-16, 1402/08/25
Ethics committee reference number
IR.TUMS.SINAHOSPITAL.REC.1402.104

Health conditions studied

1

Description of health condition studied
hypomagnesemia
ICD-10 code
E83.4
ICD-10 code description
Disorders of magnesium metabolism

Primary outcomes

1

Description
The number of patients who have more than 50% magnesium retention at the end of the study.
Timepoint
Urine collection 24 hours after magnesium administration.
Method of measurement
24-hour urine collection and examination of magnesium excreted in 24-hour urine

Secondary outcomes

1

Description
Change in the percentage of urinary magnesium excreted compared to the baseline condition.
Timepoint
Measurement of urine magnesium before starting treatment and after finishing treatment
Method of measurement
Measurement of urine magnesium after 24hour

Intervention groups

1

Description
Intervention group: Correction of the patient's hypomagnesemia by administering continuous infusion of magnesium sulfate (7.5 gram magnesium sulfate manufactured by Daro Pakhsh industry) during 24 hours and for 3 days
Category
Treatment - Drugs

2

Description
Intervention group: Correction of the patient's hypomagnesemia by administering magnesium sulfate (7.5 gram magnesium sulfate manufactured by Daro Pakhsh industry) during a 4-hour infusion for 3 days
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Sina hospital
Full name of responsible person
Farhad Najmeddin
Street address
Sina hospital, Hassan-abad square, Tehran
City
Tehran
Province
Tehran
Postal code
١١٣٦٧٤٦٩١١
Phone
+98 21 6104 0000
Email
hosp_sina@sina.tums.ac.ir

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Dr. Akbari Sari
Street address
Sina hospital, Hassan-abad square, Tehran
City
Tehran
Province
Tehran
Postal code
١١٣٦٧٤٦٩١١
Phone
+98 21 6104 0000
Email
f-najmeddin@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

Person responsible for general inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Farhad Najmeddin
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Medical Pharmacy
Street address
Clinical pharmacy department office, Pharmacy faculty, 16th Azar St.
City
Tehran
Province
Tehran
Postal code
1136746911
Phone
+98 21 6695 4709
Fax
Email
f-najmeddin@sina.tums.ac.ir

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Farhad Najmeddin
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Medical Pharmacy
Street address
Clinical pharmacy department office, Pharmacy faculty, 16th Azar St.
City
Tehran
Province
Tehran
Postal code
1136746911
Phone
+98 21 6695 4709
Fax
Email
f-najmeddin@sina.tums.ac.ir

Person responsible for updating data

Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Farhad Najmeddin
Position
Assistant professor
Latest degree
Subspecialist
Other areas of specialty/work
Medical Pharmacy
Street address
Clinical pharmacy department office, Pharmacy faculty, 16th Azar St.
City
Tehran
Province
Tehran
Postal code
1136746911
Phone
+98 21 6695 4709
Fax
Email
f-najmeddin@sina.tums.ac.ir

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
Clinical results will be published through an original article and All other data will be available on request
When the data will become available and for how long
Up to 5 years after publishing the clinical results
To whom data/document is available
Researchers and ethics committee
Under which criteria data/document could be used
Ethical evaluation and review articles without financial conflicts of interest.
From where data/document is obtainable
Responsible Researcher Dr farhadnajmeddin by the following email f-najmeddin@tums.ac.ir
What processes are involved for a request to access data/document
Data will be available within 2 weeks after the email check. The email should include the Conflict of interest disclosure
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