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CTRI Number  CTRI/2024/06/069126 [Registered on: 18/06/2024] Trial Registered Prospectively
Last Modified On: 05/06/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Study to compare the effect of Injection Labetalol and Injection Glyceryl Trinitrate in the treatment of high blood pressure 
Scientific Title of Study   A Randomized Controlled Open Label Prospective Study to Assess Efficacy and Safety of Intravenous Labetalol Vs Intravenous Glyceryl Trinitrate in the Management of Hypertensive Crisis 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  ABHIJIT KUMAR SINHA 
Designation  1st YEAR POST GRADUATE TRAINEE 
Affiliation  KPC MEDICAL COLLEGE and HOSPITAL 
Address  Department of Pharmacology KPC Medical College and Hospital 1F Raja S C Mullick Road Jadavpur

Kolkata
WEST BENGAL
700032
India 
Phone  9681094935  
Fax    
Email  abhijeetkumar.shina@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  ABHIJIT KUMAR SINHA 
Designation  1st year Post Graduate Trainee 
Affiliation  KPC MEDICAL COLLEGE and HOSPITAL 
Address  Department of Pharmacology KPC Medical College and Hospital 1F Raja S C Mullick Road Jadavpur

Kolkata
WEST BENGAL
700032
India 
Phone  9681094935  
Fax    
Email  abhijeetkumar.shina@gmail.com  
 
Details of Contact Person
Public Query
 
Name  ABHIJIT KUMAR SINHA 
Designation  1st year Post Graduate Trainee 
Affiliation  KPC MEDICAL COLLEGE and HOSPITAL 
Address  Department of Pharmacology KPC Medical College and Hospital 1F Raja S C Mullick Road Jadavpur

Kolkata
WEST BENGAL
700032
India 
Phone  9681094935  
Fax    
Email  abhijeetkumar.shina@gmail.com  
 
Source of Monetary or Material Support  
KPC Medical College and Hospital 
 
Primary Sponsor  
Name  KPC Medical College and Hospital 
Address  1F RAJA S C MULLICK ROAD,JADAVPUR,KOLKATA 700032 
Type of Sponsor  Private 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 
Abhijit Kumar Sinha  KPC Medical COllege and Hospital  Department Of Pharmacology 1F Raja S C Mullick Road Jadavpur
Kolkata
WEST BENGAL 
7003764821

abhijeetkumar.shina@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC, KPC Medical College and Hospital  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: I169||Hypertensive crisis, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  GLyceryl Trinitrate  Glyceryl Trinitrate started as intravenous infusion, starting at a dose of 5 mcg /min and dose will be up titrated every 2–5 minute, up to a maximum of 200 mcg /min. 
Intervention  Intravenous Labetalol  Labetalol 20 mg given as stat dose, followed by incremental doses of 20–80 mg every 10 minute until the target BP goal is achieved. Maximum dose of labetalol will be 300 mg. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  90.00 Year(s)
Gender  Both 
Details  1.SBP ≥180 mm Hg / DBP ≥120 mm Hg with evidence of acute end organ damage
2.Patient above 18 years of age.
3.Patient / legally acceptable representative of the patient who are willing to provide informed written consent.
 
 
ExclusionCriteria 
Details  COPD, Bradycardia , Pregnancy ,LVEF less than 35% , recent use of any intravenous beta blockers or antihypertensives or phosphodiesterase inhibitors. 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Centralized 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Proportion of patients achieving the target MABP (reduction of the MABP by 25% from the original MABP at presentation) in the groups receiving GTN and Labetalol  At baseline , 1 hour, 2 hours and 24 hours. 
 
Secondary Outcome  
Outcome  TimePoints 
Systolic and Diastolic blood pressure  30 mins,1hour, 2 hours, 6 hours, 12 hours, 24 hours 
 
Target Sample Size   Total Sample Size="68"
Sample Size from India="68" 
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 4 
Date of First Enrollment (India)   24/06/2024 
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="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  

1. BACKGROUND OF PRESENT STUDY:

Hypertensive crisis is a severe form of hypertension, characterized by a systolic blood pressure ≥180mm Hg or a diastolic blood pressure ≥120mm Hg. Hypertensive crisis is associated with high risk of mortality if left untreated, and current guidelines recommend reducing the mean arterial blood pressure (MABP) by 25% within 1 to 2 hours to manage the same. Intravenous Labetalol and intravenous nitro- glycerine (GTN) are amongst the most commonly prescribed agents to control hypertensive crisis. But there is lack of clear-cut recommendation regarding which one among these two drugs should be preferred over the other in this situation.

 

 

2.OBJECTIVES OF PROPOSED RESEARCH:

To compare the Efficacy and safety of intravenous Labetalol with intravenous Glyceryl trinitrate in the management of hypertensive crisis.

 

 

3.METHODOLOGY:

After obtaining Institutional Ethics Committee approval, screening of hypertensive patients according to inclusion and exclusion criteria will be done. Written informed consent of every patient will be taken and patients will be randomly allocated to the study groups. First group with 34 patients will receive intravenous Labetalol and second group with 34 patients will receive intravenous infusion of Glyceryl trinitrate. The outcomes like systolic blood pressure (SBP) and diastolic blood pressure (DBP), vital signs, any adverse events etc will be recorded in 30 minutes, 1 hour, 2-hour ,6-hour, 12 hour and 24 hours. Data analysis and interpretation will be done.

 

4.EXPECTED OUTCOMES:

Outcomes of this study may help in selection of optimal therapy with minimal safety issues by removing ambiguity, and reduce time and resource lost in decision making. The results may also help in formulation of Institutional standard treatment guidelines.

 
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