Acute Exacerbation of COPD and Nebulized Magnesium Sulphate

NCT05699720 | Completed DMC

• 1 other identifier: 7372/REG/KEMU2018
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 1

Brief Summary

This study is designed to determine the effect of Nebulized Magnesium Sulphate as an add-on therapy with conventional treatment on In-hospital outcome in patients having acute exacerbation of COPD.

Conditions

Chronic Obstructive Pulmonary Disease Exacerbation; Magnesium Sulfate

Outcome Measures

Primary Outcomes (1)

• In- Hospital Outcome

  discharge or death or clinical improvement

  5 days

Study Arms (2)

Magnesium Sulphate

EXPERIMENTAL

Conventional treatment and 250mg of MgSO4 through nebulizer four times a day. 1 vial of injection MgSO4 was taken which contains 1gm of MgSO4 (each vial contains 10ml). It was divided into 4 equal parts, each contained 250mg MgSO4 i.e., 2.5 ml solution, which were used for nebulization 4 times a day.

Drug: Nebulized Magnesium Sulphate

Conventional

NO INTERVENTION

conventional treatment in the form of oxygen inhalation, anti-cholinergic and beta-2 agonist nebulization, intravenous steroids, as well as intravenous antibiotics.

Interventions

Nebulized Magnesium Sulphate DRUG

Group A received 250mg of MgSO4 /dose given through nebulizer four times a day, while group B did not. The groups will be followed for five days to see the results in terms of in-hospital outcome, whether the patient is discharged after fulfilling the set criteria or needing assisted ventilation.

Magnesium Sulphate

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. The age of patient should between 30 to 70 years. 2. The patient could be male or female. 3. The duration of COPD must be less than 10 years. 4. Acute exacerbation of COPD requiring hospital admission and any two out of four criteria: I. Increase in the purulence or quantity of sputum II. Dyspnea grade 3, 4 or 5 according to MRC scale (Annexure attached) III. PEFR \<200 L/min IV. Respiratory acidosis on arterial blood gas analysis

You may not qualify if:

• \- 1. Known case of other pulmonary parenchymal disease diagnosed by history, examination and previous medical records.
• \. Bronchogenic carcinoma diagnosed by history and previous records. 3. Pulmonary edema diagnosed based on history, examination and investigations.

Sponsors & Collaborators

• King Edward Medical University: lead

Study Sites (1)

Fawad Ahmad Randhawa

Lahore, Punjab Province, 54000, Pakistan

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: December 15, 2021
• First Posted: January 26, 2023
• Study Start: January 1, 2019
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: January 26, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)