| CTRI Number |
CTRI/2024/10/075401 [Registered on: 16/10/2024] Trial Registered Prospectively |
| Last Modified On: |
10/10/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
comparison of effect of magnesium sulphate as an add-on therapy by different routes administration during acute exacerbation of chronic obstructive pulmonary disease |
|
Scientific Title of Study
|
Comparing the effect of intravenous and nebulised magnesium sulphate as an adjunctive therapy during acute exacerbation of chronic obstructive pulmonary disease, A randomized control trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Nidhi Anilkumar Bardiya |
| Designation |
Junior Resident |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Department of General Medicine,
AVBRH building, Third floor, Sawangi, Meghe
Wardha MAHARASHTRA 442001 India |
| Phone |
8888033435 |
| Fax |
|
| Email |
bardiyanidhi200398@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Shilpa Bawankule |
| Designation |
Professor |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Department of General Medicine,
AVBRH building, Third floor, Sawangi, Meghe
Wardha MAHARASHTRA 442001 India |
| Phone |
9673288822 |
| Fax |
|
| Email |
drshilpagaidhane@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Shilpa Bawankule |
| Designation |
Professor |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Department of General Medicine,
AVBRH building, Third floor, Sawangi, Meghe
MAHARASHTRA 442001 India |
| Phone |
9673288822 |
| Fax |
|
| Email |
drshilpagaidhane@gmail.com |
|
|
Source of Monetary or Material Support
|
| Datta Meghe Institute of Higher Education and Research, Sawangi, Meghe, Wardha, India 442001 |
|
|
Primary Sponsor
|
| Name |
Datta Meghe Institute of Higher Education and Research |
| Address |
Sawangi, Meghe, Wardha, India 442001 |
| Type of Sponsor |
Private medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Nidhi Anilkumar Bardiya |
Acharya Vinoba Bhave Rural Hospital |
Department of General Medicine, AVBRH building, Third floor Wardha MAHARASHTRA |
8888033435
bardiyanidhi200398@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Datta Meghe Institute of Higher Education and Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J99||Respiratory disorders in diseasesclassified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
intravenous infusion of magnesium sulphate |
intravenous infusion of 2 gm magnesium sulphate over 20 minutes as a single dose at presentation along with standard therapy during acute exacerbation of chronic obstructive pulmonary disease |
| Comparator Agent |
Nebulization with magnesium sulphate |
Nebulization with 250 mg of magnesium sulphate over two minutes for three times at an interval of 30 minutes each which is at presentation, at 30 minutes and at 60 minutes from presentation along with standard therapy during acute exacerbation of chronic obstructive pulmonary disease |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
75.00 Year(s) |
| Gender |
Both |
| Details |
Clinically diagnosed cases of chronic obstructive pulmonary disease experiencing a moderate acute exacerbation according to the ROME proposal |
|
| ExclusionCriteria |
| Details |
Patients requiring immediate endotracheal intubation on arriving at the emergency medicine department.
Patients with severe symptoms like breathlessness who are unable to blow into the PEFR device.
Patients with altered sensorium or reduced levels of consciousness unable to blow in the PEFR device.
Patients in shock with systolic blood pressure less than 100 mmhg
Patients with dyselectrolytemia contraindicating the use of magnesium sulphate like hyperkalaemia and hypocalcaemia
Patients with renal failure and heart block.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| 1. Assessment of improvement in the peak expiratory flow rate, blood gas analysis results and vital signs including heart rate, respiratory rate and oxygen saturation among participants in the study group. |
At presentation and at 60 minutes after presentation. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 2. To monitor the symptomatic relief based on CAT score and assess the need for ICU admission, duration of hospital stay, need for invasive or non-invasive mechanical ventilation along with q SOFA score and CURB-65 score in these patients so as to determine the mortality and morbidity among the participants from the study group |
at presentation and 60 minutes after presentation. |
|
|
Target Sample Size
|
Total Sample Size="112" Sample Size from India="112"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
01/11/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1" Months="0" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Background: Chronic obstructive pulmonary disease, characterised by chronic respiratory symptoms like dyspnoea, cough, sputum production and is often associated with episodes of acute exacerbations which may occur due to various triggers like bacterial or viral infections, exposure to pollutants like biomass fuels, crop residues, woods etc. various treatment modalities have been implicated in the management of these episodes of acute exacerbations of COPD. This randomized control trial aims to compare the effect of intravenous and nebulised magnesium sulphate as an adjunctive therapy during acute exacerbation of chronic obstructive pulmonary disease in this sample population. Methods: The study will be conducted in within Department of medicine, at AVBRH, a tertiary care teaching hospital placed within geographic region of Wardha District. Study is done when approved via institute moral committee (applied for).The participants with acute exacerbation of chronic obstructive pulmonary disease will be randomized using a computer generated random sequence into two groups, Group A receiving intravenous injection of magnesium sulphate as a single dose on presentation to emergency department and Group B receiving nebulisation with magnesium sulphate three times at an interval of 30 minutes each time (i.e on presentation, at interval of 30 minutes and then at 60 minutes from the time of presentation, as an adjunctive along with standard treatment for acute exacerbations of COPD. Various investigations will be conducted at baseline and throughout the study period, including peak expiratory flow rate (PEFR), arterial blood gas analysis (ABG), chest x ray, complete blood count and CURB-65, q SOFA and CAT scores will be assessed. Expected Results: It is anticipated that intravenous magnesium sulphate as an adjunctive in treatment of acute exacerbation of chronic obstructive pulmonary disease will lead to improvement in bronchospasm and improve dyspnoea score, decrease the need for hospitalisation and / or duration of hospital stay among participants with acute exacerbation of COPD whereas nebulized magnesium sulphate may reduce the number of ICU admissions and improve dyspnoea. Positive effect of intravenous and nebulized magnesium sulphate as an adjunct in management of acute exacerbation of COPD and study outcomes are expected. Adherence to the intervention protocol and the safety and tolerability of intravenous and nebulized magnesium sulphate will also be evaluated. |