]>
IRCT2014111519962N1 IRCT 2015-02-04 Vice Chanceller for research of Mashhad University of Medical Sciences The effect of intravenous magnesium sulfate in the treatment of patients with chronic obstructive pulmonary disease The effect of intravenous magnesium sulphate as an adjuvant in the treatment of acute exacerbations of COPD in adults 2015-01-30 anticipated 90 Complete https://irct.ir/trial/17716 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: We performed block randomization with a block size of 4 using a computer generated random sequence. This was administered by a third party process so that patients and researchers were unaware of allocation and randomly allocated patients to one of the two groups of the study. The MgSO4 group received vial A. The placebo group received vial B, Blinding description: Daily, the chief nurse who was not involved in the patients’ care blindly provided the MgSO4/placebo by filling similar vials, labeled A or B, with 5 mL MgSO4 (50% solution) or 5 mL sterile water. The MgSO4 group received vial A. The placebo group received vial B. 3 Chronic Obstructive Pulmonary Disease. Intervention 1: intervention in control group: receive 5 cc of sterile water in 50 cc normal saline. Intervention 2: intervention in case group: infusion of 2.5 grams of Mgso4 in 50 cc normal saline in 20 minutes. Yes - There is a plan to make this available What will be shared: The data related to the main outcomes and the basic characteristics of patients When: 6 months after publication of the manuscript of this study To whom: academic researchers Conditions: for clinical studies Where to obtain: Elham Pishbin Tel: 00985138525312 pishbine@mums.ac.ir How to obtain: The request should be sent to the main investigator (Elham Pishbin) whose address is mentioned above and also a copy to the vice chancellor for research in Mashhad university of medical scinces Comments:
public Elnaz Vafadar Moradi
Imam Reza Square- Ibne e Sina street
Masshah Iran (Islamic Republic of) ٩١٣٧٩١٣٣١۶ +98 51 3852 5312 elnaz.vafadar@gmail.com Mashhad University of Medical Sciences - Imam Reza hospital scientific Elham Pishbin
Imam Reza squer , Ibn e Sina street
Mashhad Iran (Islamic Republic of) 9137913316 +98 51 3852 5312 pishbine@mums.ac.ir Mashhad University of Medical Sciences - Imam Reza hospital Iran (Islamic Republic of) patient older than 18 years acute exacerbation of COPD 18 years no limit Both any other underlying causes for dyspnea including heart failure, asthma, renal failure, pneumothorax, pneumoni Not willingness to participate J44.1 Chronic obstructive pulmonary disease with acute exacerbation, unspecified Treatment - Drugs Treatment - Drugs intervention in control group: receive 5 cc of sterile water in 50 cc normal saline intervention in case group: infusion of 2.5 grams of Mgso4 in 50 cc normal saline in 20 minutes Subjective improvement of dyspnea. Timepoint: First time after the initial dose of nebulized bronchodilator and second time after the treatment protocol (3 doses of bronchodilators and even Magnesium or placebo infusion). Method of measurement: patient were asked about severity of dyspnea based on the 10 point likert scale. Peak Expiratory Flow Rate(PEFR) improvement. Timepoint: First time after the initial dose of nebulized bronchodilator and second time after the treatment protocol (3 doses of bronchodilators and even Magnesium or placebo infusion). Method of measurement: Peak-flow-metry. Intubation during the course of admition. Timepoint: any time during first 12 hours of admition. Method of measurement: Based on patients records. Length of hospital stay. Timepoint: time of discharge from hospital. Method of measurement: Based on patients records. Vice Chanceller for research of Mashhad University of Medical Sciences Approved 2014-11-22 Mashhad University of Medical Sciences Daneshgah Ave. Ghoreyshi building Mashhad Razavi Khorasan Iran (Islamic Republic of)