| CTRI Number |
CTRI/2024/07/071431 [Registered on: 26/07/2024] Trial Registered Prospectively |
| Last Modified On: |
26/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Hemodynamic instability comparison between prazosin and amlodipine in PPGL(pheochromocytoma and paraganglioma) |
|
Scientific Title of Study
|
Comparative analysis of Pre-operative Prazosin versus Am-lodipine on Intraoperative Hemodynamic Instability in Patients with Pheochromocytoma/Paraganglioma (PPGL): An Open-label Randomized Controlled 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 |
RAJKAMAL M |
| Designation |
Senior Resident |
| Affiliation |
Jawaharlal Institute of Postgraduate Medical Education and Research(JIPMER),PONDICHERRY |
| Address |
Department of Endocrinology
Jawaharlal Institute of Postgraduate Medical Education and Research(JIPMER)
Pondicherry
PONDICHERRY
605006
India |
| Phone |
7200991684 |
| Fax |
|
| Email |
rajmaruthu202@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sadishkumar kamalanathan |
| Designation |
Professor |
| Affiliation |
Jawaharlal Institute of Postgraduate Medical Education and Research(JIPMER),PONDICHERRY |
| Address |
Department of Endocrinology
Jawaharlal Institute of Postgraduate Medical Education and Research(JIPMER)
Pondicherry
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9629528518 |
| Fax |
|
| Email |
sadishkk@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sadishkumar kamalanathan |
| Designation |
Professor |
| Affiliation |
Jawaharlal Institute of Postgraduate Medical Education and Research(JIPMER),PONDICHERRY |
| Address |
Department of Endocrinology
Jawaharlal Institute of Postgraduate Medical Education and Research(JIPMER)-PONDICHERRY
Pondicherry
PONDICHERRY
605006
India |
| Phone |
9629528518 |
| Fax |
|
| Email |
sadishkk@gmail.com |
|
|
Source of Monetary or Material Support
|
| Jawaharlal Institute of Postgraduate Medical Education and Research(JIPMER)
Gorimedu
Puducherry-605006
India |
|
|
Primary Sponsor
|
| Name |
Jawaharlal Institute of Postgraduate Medical Education and ResearchJIPMER |
| Address |
Jawaharlal Institute of Postgraduate Medical Education and Research(JIPMER)
Gorimedu
Puducherry-605006
India |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Rajkamal M |
Jawaharlal Institute of Postgraduate Medical Education and Research(JIPMER),Pondicherry |
3rd floor
Room no-5321
Superspeciality block
Department of Endocrinology ward
Jawaharlal Institute of Postgraduate Medical Education and Research(JIPMER)
Gorimedu
Puducherry-605006
India
Pondicherry
PONDICHERRY |
7200991684
rajmaruthu202@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE INTERVENTIONAL STUDIES-Jawaharlal Institute of Postgraduate Medical Education and Research(JIPMER), Office of the Dean Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E368||Other intraoperative complicationsof endocrine system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
AMLODIPINE |
Tablet Amlodipine will be started at the dosage of 2.5 mg once daily per oral and up-titrated at dose of 2.5 mg increments daily up to 10 mg in two divided doses then in increments of 5 mg daily to the maximum dose of 20 mg in two divided doses
Amlodipine will be given during pre-operative preparation in pheochromocytoma/paraganglioma
As the waiting list for surgery varies, total duration of therapy may vary. However it will be usually given for 14-21 days
|
| Comparator Agent |
Tablet PRAZOSIN |
Tablet Prazosin will be started at the dosage of 2.5 mg once daily orally and will be gradually up-titrated in increments of 2.5 mg daily until a dose of 15 mg upto 3 divided doses and then in increments of 5 mg daily to the maximum dose of 30 mg upto 4 divided doses. Prazosin will be given during pre-operative preparation in pheochromocytoma/paraganglioma As the waiting list for surgery varies, total duration of therapy may vary. However it will be usually given for 14-21 days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Male |
| Details |
1. Age- 18-65 years
2. Secretory PPGL - Elevated plasma-free meta-nephrine and or plasma-free normetanephrine irre-spective of Blood pressure recordings
3. Planned for surgical removal
|
|
| ExclusionCriteria |
| Details |
1. Bilateral tumour
2. Distant metastasis
3. Pregnancy
4. Incapability to adhere to study protocol
|
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To determine the efficacy of amlodipine in reducing the intra-operative hemodynamic instability duration (%) in patients with PPGL compared to prazosin |
At the end of surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To determine the efficacy of amlodipine in reducing the intraoperative hemodynamic instability score in patients with PPGL compared to prazosin
To study Ambulatory blood pressure monitoring
(ABPM ) characteristics pre-operatively & hemo-dynamic instability post-operatively in patients with PPGL
To identify the factors influencing hemodynamic in-stability during the peri-operative period
|
At the end of 24 hours after surgery |
|
|
Target Sample Size
|
Total Sample Size="18"
Sample Size from India="18"
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
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
10/08/2024 |
| 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="2"
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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Informed Consent Form
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - For individual participant data meta-analysis.
- By what mechanism will data be made available?
Response (Others) - Correspondence with corresponding author
- For how long will this data be available start date provided 01-01-2027 and end date provided 26-12-2032?
Response - Beginning 3 months and ending 5 years following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
|
Even
though alpha-blocker is used as frequently for pre-operative blockade in
PPGL, prospective randomized controlled trials comparing various antihypertensive
agents on peri-operative hemodynamic instability are lacking. There are various institutional protocols
and some institutions are using calcium-channel blockers as the first line of
management. Even
though there are limited studies,study
results revealed calcium channel blockers can be used as an alternative to alpha-blockers
and even superior hemodynamic control.
Novelty:
Since
PPGL is a rare clinical condition, there are fewer studies on the assessment
of intraoperative hemodynamic instability.
There
are limited studies on calcium channel
blockers as the first line of pre-operative treatment in PPGL Expected
outcomes:
We are expecting a reduction in the incidence and duration of hypotensive and
hypertensive episodes during the perioperative period while using amlodipine
as compared to prazosin.
|
|