| CTRI Number |
CTRI/2025/10/095964 [Registered on: 13/10/2025] Trial Registered Prospectively |
| Last Modified On: |
11/10/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Retrospective study |
| Study Design |
Other |
|
Public Title of Study
|
A Study On Surgical Outcomes And Recovery In Patients Undergoing Heart Valve Replacement At A Major Hospital |
|
Scientific Title of Study
|
Retrospective Study Of Perioperative Outcomes And Prognosis In Patients Undergoing Heart Valve Replacement Surgery At A Tertiary Care Centre |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ranjeet Kumar |
| Designation |
Senior Resident |
| Affiliation |
IMS BHU |
| Address |
Senior resident
Department of Anaesthesiology
Institute of medical sciences
BHU,Varanasi
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
8318984715 |
| Fax |
|
| Email |
ronneyraj61@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Sanjeev Kumar |
| Designation |
Assistant Professor |
| Affiliation |
IMS BHU |
| Address |
Assistant Professor
Department of Anaesthesiology
Institute of Medical Sciences
BHU,Varanasi
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9650063508 |
| Fax |
|
| Email |
dr.Sanjeevkumarkem@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sanjeev Kumar |
| Designation |
Assistant Professor |
| Affiliation |
IMS BHU |
| Address |
Assistant Professor
Department of Anaesthesiology
Institute of Medical Sciences
BHU,Varanasi
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9650063508 |
| Fax |
|
| Email |
dr.Sanjeevkumarkem@gmail.com |
|
|
Source of Monetary or Material Support
|
| Division Of Cardiac Anaesthesia
Department of Anaesthesiology,IMS BHU,Varanasi |
|
|
Primary Sponsor
|
| Name |
Dr Ranjeet Kumar |
| Address |
Senior resident
Department of Anaesthesiology
IMS,BHU |
| Type of Sponsor |
Other [Self] |
|
|
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 Ranjeet Kumar |
CTVS OT and CTVS ICU, Department of CTVS, |
CSSB IMS BHU Varanasi
Varanasi
UTTAR PRADESH |
8318984715
rooneyraj61@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics committee Bhu ims |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I088||Other rheumatic multiple valve diseases, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
All Patients Underwent Valve Replacement Surgery With Complete Medical Records Available |
|
| ExclusionCriteria |
| Details |
Concomitant coronary artery bypass grafting or other cardiac surgeries.
Incomplete or Missing peri operative data.
Redo Valve surgeries
Patients on mechanical ventilation and dialysis taken up for Surgery. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To assess and compare the perioperative outcomes and prognosis in patients undergoing cardiac valve replacement surgery at tertiary care cardiothoracic centre
To assess prosthetic valve related complications which are paravalvular leak and gradient across prosthetic valve |
4 Week / Till Discharge of Patient |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To identify factors influencing prognosis & long term survival
To evaluate the incidence of peri operative complications example arrhythmias , thromboembolic event, post operative bleeding , re exploration & sepsis
To assess ICU stay duration & correlate it with clinical outcomes |
4 week /Till discharge of patients |
|
|
Target Sample Size
|
Total Sample Size="180"
Sample Size from India="180"
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
|
N/A |
|
Date of First Enrollment (India)
|
11/11/2025 |
| 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 study aims to evaluate and compare the perioperative outcomes and prognosis indicators in patients undergoing valve Replacement surgery at tertiary care cardiothoracic centre in northern India. This can help refine perioperative care protocols, guide future research, and enhance patients care. |