| 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
|
|
|
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
|
|
|
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. |