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IRCT20200322046833N4 IRCT 2024-01-05 Tehran University of Medical Sciences Comparison of two methods of administering magnesium through continuous infusion (۲۴ hours) and short-term infusion (۴ hours) in the correction of hypomagnesemia 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 2024-01-21 anticipated 30 Complete https://irct.ir/trial/73769 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, 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. 3 hypomagnesemia. Intervention 1: 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. Intervention 2: 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. Yes - There is a plan to make this available What will be shared: Clinical results will be published through an original article and All other data will be available on request When: Up to 5 years after publishing the clinical results To whom: Researchers and ethics committee Conditions: Ethical evaluation and review articles without financial conflicts of interest. Where to obtain: Responsible Researcher Dr farhadnajmeddin by the following email f-najmeddin@tums.ac.ir How to obtain: Data will be available within 2 weeks after the email check. The email should include the Conflict of interest disclosure Comments:
public Farhad Najmeddin
Clinical pharmacy department office, Pharmacy faculty, 16th Azar St.
Tehran Iran (Islamic Republic of) 1136746911 +98 21 6695 4709 f-najmeddin@sina.tums.ac.ir Tehran University of Medical Sciences scientific Farhad Najmeddin
Clinical pharmacy department office, Pharmacy faculty, 16th Azar St.
Tehran Iran (Islamic Republic of) 1136746911 +98 21 6695 4709 f-najmeddin@sina.tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) Hypomagnesemia patients hospitalized in the intensive care unit Less than 96 hours have passed since ICU admission. written consent to enter the study 18 years no limit Both 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​ E83.4 Disorders of magnesium metabolism Treatment - Drugs Treatment - Drugs 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 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 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. 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. Tehran University of Medical Sciences Approved 2023-11-16 Ethics Committee of Sina Hospital - Tehran University of Medical Sciences Sina Hospital, Imam Khomeini St, Hasanabad Square, Tehran, Iran Tehran Tehran Iran (Islamic Republic of)