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IRCT20250528065953N1 IRCT 2025-07-21 Kashan University of Medical Sciences Inhaled magnesium sulfate in COPD (Chronic Obstructive Pulmonary Diseases) The effect of inhaled magnesium sulfate on the duration of hospitalization and spirometry indicators in patients with chronic obstructive pulmonary disease 2025-08-01 anticipated 384 Complete https://irct.ir/trial/84161 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Block randomization was used, with the individual as the unit of randomization. To randomly assign participants to the study groups, a block randomization method with blocks of four was applied. The blocks included the following sequences: (AABB), (BBAA), (BABA), (ABAB), (ABBA), and (BAAB), where "A" represents the treatment group and "B" represents the placebo group. The selection of blocks was performed using the RandInt function in Microsoft Excel, Blinding description: Since an objective measurement tool is used in the study, the risk of bias is minimized. Additionally, a placebo will not be used, as all patients receive standard bronchodilator therapy via nebulizer during treatment. Therefore, only the clinical data analyst and outcome assessor will be blinded to the treatment allocation. 3 Chronic Obstructive pulmonary Disease Exacerbation. Intervention 1: Intervention group: The other 118 patients, in addition to receiving standard treatment, will be administered ready-to-use vials of inhaled magnesium sulfate via nebulizer at a dose of 1 gram every 12 hours for five days. Intervention 2: Control group: 118 patients will receive standard treatment for acute exacerbation of COPD, which includes supplemental oxygen (if oxygen saturation is below 88% in patients without a cardiac history), bronchodilators (salbutamol administered via nebulizer or MDI depending on the patient's condition), systemic corticosteroids at the standard COPD dose (35 to 40 mg of prednisolone or its equivalent), and broad-spectrum antibiotics for five days. Yes - There is a plan to make this available What will be shared: The data will be fully accessible only after ensuring the anonymity of the participants. When: 6 months after publication To whom: Every individual who send his/her request to corresponding author and corresponding author confirm his/her access Conditions: the purpose is to ensure the proper conduct of the study and to use the data for more accurate future research." Where to obtain: Corresponding author How to obtain: Send email to corresponding author - assessment of the request and confirm/reject the access Comments:
public Amir Dasdar
Pezeshk Blvd., Qotb Blvd.
Kashan Iran (Islamic Republic of) 8715988141 +98 31 5558 9347 Dasdar-A@kaums.ac.ir Kashan University of Medical Sciences scientific Yazdan Jafari
Pezeshk Blvd., Qotb Blvd.
Kashan Iran (Islamic Republic of) 8715988141 +98 31 5558 9347 Jafari-A@kaums.ac.ir Kashan University of Medical Sciences Iran (Islamic Republic of) Individuals with a history of COPD who have been hospitalized due to acute exacerbations Individuals who have been diagnosed with COPD through spirometry Individuals who have an FEV1 of 80% or lower and/or an FEV1/FVC ratio of less than 70%. 18 years no limit Both Pneumonia Malignancy CHF (Congestive Heart Failure) Astham Hospitalization for a reason other than chronic obstructive pulmonary disease (COPD) exacerbation. J44.1 Chronic obstructive pulmonary disease with (acute) exacerbation Treatment - Drugs Placebo Intervention group: The other 118 patients, in addition to receiving standard treatment, will be administered ready-to-use vials of inhaled magnesium sulfate via nebulizer at a dose of 1 gram every 12 hours for five days. Control group: 118 patients will receive standard treatment for acute exacerbation of COPD, which includes supplemental oxygen (if oxygen saturation is below 88% in patients without a cardiac history), bronchodilators (salbutamol administered via nebulizer or MDI depending on the patient's condition), systemic corticosteroids at the standard COPD dose (35 to 40 mg of prednisolone or its equivalent), and broad-spectrum antibiotics for five days. Length of Hospital stay. Timepoint: Once, at the time of the patient's discharge. Method of measurement: Patient medical records. FEV1/FVC. Timepoint: Baseline and after 5 days. Method of measurement: with Spirometry. Admission Interval. Timepoint: Up to 6 month after the primary discharge. Method of measurement: Based on the patient's medical record. GOLD. Timepoint: On each admission time. Method of measurement: Based on Spirometry and GOLD criteria. FEV1. Timepoint: Baseline (from the admission) and 5 days after admission. Method of measurement: Spirometry. Kashan University of Medical Sciences Approved 2025-05-11 Research Ethics Committees of Faculty of Medicine & Faculty of Dentistry – Kashan University of Medi Pezeshk Blvd. Qotb Blvd. Kashan Isfehan Iran (Islamic Republic of)