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CTRI Number  CTRI/2024/05/066775 [Registered on: 03/05/2024] Trial Registered Prospectively
Last Modified On: 02/05/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Benefit of injection magnesium sulphate in patient with increased shortness of breath in COPD patients 
Scientific Title of Study   The effect of intravenous magnesium sulphate in acute exacerbation of chronic obstructive pulmonary disease patient requiring non-invasive ventilation support: a randomized clinical 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  SADANANDA BARIK 
Designation  Associate professor 
Affiliation  AIIMS BHUBANESWAR 
Address  Faculty room, Department of Trauma and Emergency, AIIMS Bhubaneswar
Sijua, Patrapada, Bhubaneswar
Khordha
ORISSA
751019
India 
Phone  07682959066  
Fax    
Email  tem_sadananda@aiimsbhubaneswar.edu.in  
 
Details of Contact Person
Scientific Query  
Name  Nandakishore Rathod 
Designation  Academic junior resident 
Affiliation  AIIMS BHUBANESWAR 
Address  Resident Room, Department of Trauma and Emergency, AIIMS Bhubaneswar
Sijua,Patrapada, BHUBANESWAR
Khordha
ORISSA
751019
India 
Phone  9764048831  
Fax    
Email  tem_sadananda@aiimsbhubaneswar.edu.in  
 
Details of Contact Person
Public Query  
Name  SADANANDA BARIK 
Designation  Associate professor 
Affiliation  AIIMS BHUBANESWAR 
Address  Faculty room, Department of Trauma and Emergency, AIIMS Bhubaneswar
Sijua, Patrapada, Bhubaneswar
Khordha
ORISSA
751019
India 
Phone  07682959066  
Fax    
Email  tem_sadananda@aiimsbhubaneswar.edu.in  
 
Source of Monetary or Material Support  
All India Institute of Medical Science,Bhubaneswar Adress: Sijua, Patrapada, Bhubaneswar District- Khorda, State- Odisha, India, PIN 751019 
 
Primary Sponsor  
Name  All India Institute of Medical Sciences Bhubaneswar 
Address  SIJUA, PATRAPADA, BUBANESWAR, ODISHA, PIN- 751019 
Type of Sponsor  Government medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Sadananda Barik  All India Institute of Medical Science Bhubaneswar  Faculty room, Department of Trauma and Emergency, Sijua Patrapada, Bhubaneswar
Khordha
ORISSA 		 7682959066

tem_sadananda@aiimsbhubaneswar.edu.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics committee, All India Institute of Medical Sciences, Bhubaneswar  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: J441||Chronic obstructive pulmonary disease with (acute) exacerbation,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  100ml normal saline  The control group will receive standard treatment. Standard treatment include nebulisation with Lev salbutamol 1.25mg plus Ipratropium bromide 500mcg 3 times in first one hour of presentation followed by 6hourlY and injection hydrocortisone 100mg 8hourly. 
Intervention  magnesium sulphate  Patients of acute exacerbation of COPD in experimental group will receive intravenous infusion of 2gram of magnesium sulphate in 100ml of normal saline over 30 minutes only once at the time of presentation to emergency along with the standard treatment. Standard treatment include nebulisation with Lev salbutamol 1.25mg plus Ipratropium bromide 500mcg 3 times in first hour of presentation followed by 6hourlY and injection hydrocortisone 100mg 8hourly. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  80.00 Year(s)
Gender  Both 
Details  All patient of AECOPD with following criteria’s
a)pH less than 7.35, pCO2 more than 45 mm hg. or
b)persistent hypoxemia despite supplemental oxygen therapy. [persistent hypoxemia that is patient not able to maintain more than 88% after 15 min of NRBM (15L per minute O2) or
c)severe dyspnea with clinical signs suggestive of respiratory muscle fatigue, increased of work of breathing or both, such as use of respiratory accessory muscles paradoxical motion of the abdomen or retraction of intercostal spaces.
 
 
ExclusionCriteria 
Details  a)Patient with contraindication for use of mgso4 { hypersensitivity ,diabetic coma ,heart block, myocardial damage , dyselectrolytemia such as hypomagnesemia ,hypercalcemia)
b) use of I.V. mgso4 in past 24 hours
c)using medication that contain magnesium
d)pregnant women
e) pneumonia, pleural or pericardial effusion, pneumothorax, heart failure renal failure, sepsis.
f) Haemodynamically unstable patient
g) Patient requiring immediate endotracheal intubation.
h) Uncooperative patient
i) Did not consent to participate
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
1. Respiratory rate improvement
2. ABG parameters: arterial pH and pCO2 improvement.



 		 baseline, 1 hr,4hr,12hr,24hr 
 
Secondary Outcome  
Outcome  TimePoints 
a)NIV failure rate and rate endotracheal intubation.

b)Duration of NIV requirement in both groups.

c)Length of hospital stay

 		 NIV failure rate and rate endotracheal intubationation at 24hour after start of treatment 
 
Target Sample Size   Total Sample Size="80"
Sample Size from India="80" 
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/ Phase 4 
Date of First Enrollment (India)   01/06/2024 
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="0"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
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  

The precise role of intravenous magnesium sulphate in severe COPD exacerbations remains unclear. While its efficacy has been established in milder cases, its impact on severe exacerbations is yet to be distinctly defined. This study aims to find efficacy  of intravenous magnesium sulphate in acute severe COPD exacerbations requiring Non-Invasive Ventilation (NIV) support.

 Patient of acute exacerbation of COPD requiring NIV support will be recruited. Both groups will receive initial Lev salbutamol 1.25mg plus Ipratropium bromide 500 mcg nebulization 3 times in one hour duration. In addition, the experimental group will receive 2 gm intravenous magnesium sulphate in 100ml normal saline over 30 minute and control group will receive only 100 ml normal saline (placebo) over 30 min. ABG analysis will be done at 0, 1 hr, 4hr, 12hr, 24hr, after start of NIV in each group.Clinical parameters like respiratory  rate, heart rate, SpO2, dyspnea severity score will also be monitored in same time interval as above. Primary objectives are respiratory rate and arterial pH and pCO2 improvement. Secondary Objectives are a)   NIV failure rate and rate endotracheal intubation b)  duration of NIV requirement in both group c)   length of hospital stay.

 
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