| CTRI Number |
CTRI/2024/01/062110 [Registered on: 31/01/2024] Trial Registered Prospectively |
| Last Modified On: |
29/01/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Applicability of EuroSCORE II and STS score in Indian cardiac valve surgeries |
|
Scientific Title of Study
|
Study to assess the applicability of EuroSCORE II and STS score in Indian cardiac patients undergoing valve surgeries |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sanjeeta Umbarkar |
| Designation |
Professor (Addl) and Head of Department Cardiac Anaesthesia |
| Affiliation |
Seth GS medical college and KEM hospital, MUMBAI |
| Address |
CVTC Building, Room no. 305, Ground floor
Seth GS medical College and KEM hospital, Mumbai
Mumbai MAHARASHTRA 400012 India |
| Phone |
8879875834 |
| Fax |
|
| Email |
sanjeeta69@yahoo.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Sanjeeta Umbarkar |
| Designation |
Professor (Addl) and Head of Department Cardiac Anaesthesia |
| Affiliation |
Seth GS medical college and KEM hospital, MUMBAI |
| Address |
CVTC Building, Room no. 305, Ground floor
Seth GS medical College and KEM hospital, Mumbai
MAHARASHTRA 400012 India |
| Phone |
8879875834 |
| Fax |
|
| Email |
sanjeeta69@yahoo.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Sanjeeta Umbarkar |
| Designation |
Professor (Addl) and Head of Department Cardiac Anaesthesia |
| Affiliation |
Seth GS medical college and KEM hospital, MUMBAI |
| Address |
CVTC Building, Room no. 305, Ground floor
Seth GS medical College and KEM hospital, Mumbai
MAHARASHTRA 400012 India |
| Phone |
8879875834 |
| Fax |
|
| Email |
sanjeeta69@yahoo.com |
|
|
Source of Monetary or Material Support
|
| No funding - observational study |
| Seth GS Medical College and KEM hospital, Mumbai |
|
|
Primary Sponsor
|
| Name |
Seth GS medical college and KEM hospital Mumbai |
| Address |
Institutional ethic committee - 2, Seth GS medical college and KEM hospital, Mumbai |
| Type of Sponsor |
Research institution |
|
|
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 Sanjeeta Umbarkar |
Seth GS medical college and KEM hospital, Mumbai |
Second floor OT, CVTC BUILDING, Seth GS medical college and KEM hospital, Mumbai Mumbai MAHARASHTRA |
8879875834
sanjeeta69@yahoo.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee (IEC) - II, Relating to Biomedical and health research (BHR). Seth GS Medical College and KEM hospital, Mumbai, Maharashtra, India. Established - 14th November 2008 |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I080||Rheumatic disorders of both mitraland aortic valves, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients between age 18 – 60 years posted for elective isolated cardiac valvular surgeries in
CVTS OT. |
|
| ExclusionCriteria |
| Details |
1. Patient posted for double valve replacement surgeries
2. Patient undergoing CABG with valve surgeries
3. Patients not willing to participate in the study
4. Emergency valve surgeries |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
1.Discharge from hospital
2.Death during hospital stay |
Till 30 days of surgery |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Dduration since first presenting symptom
Aortic cross clamp time
Total CPB time
Days to discharge from ICU |
Intraoperative period & post operative period of cardiac surgery |
|
|
Target Sample Size
|
Total Sample Size="200" Sample Size from India="200"
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)
|
12/02/2024 |
| 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="9" 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
|
Valvular heart disease (VHD) encompasses various
structural cardiac abnormalities that disrupt normal blood flow during the
cardiac cycle. In low and middle socioeconomic countries like India, rheumatic
heart disease (RHD) remains a significant cause of VHD-related mortality and
disability, despite a decline in global numbers. Degenerative valve disease, on
the other hand, has become the most prevalent form of VHD in developed
countries due to the aging population. With over one million cardiac valve
surgeries performed worldwide annually, the need for objective risk scoring
systems for patients undergoing these surgeries has become crucial.
Accurate risk stratification of patients undergoing
cardiac valve surgeries is essential for multiple purposes, including comparing
institutional practices, improving treatment decision-making, cost-benefit
analysis, patient counselling, and quality improvement. The 2 models currently
used worldwide for cardiac surgical patients are – Society for Thoracic Surgery
(STS) and the European System for Cardiac Operative Risk Evaluation II
(EuroSCORE II). The STS risk score, which undergoes periodic updates, has proven
highly effective for predicting mortality risk in cardiac surgical patients in
the west and offers models for coronary artery bypass graft (CABG), isolated
valve surgery, and valve surgery plus CABG. The EuroSCORE II is the recommended
risk assessment model for cardiac surgeries globally. It predicts the
probability of in-hospital mortality and was accepted for clinical use in 2011.
While institutions in India rely on either EuroSCORE
II or the STS score for risk stratification, there is a lack of large-scale
studies validating the applicability of these scoring systems in the Indian
population, which typically presents with long standing disease, poor
nutritional status and multiple associated comorbidities. Some studies have
shown conflicting results regarding the accuracy of EuroSCORE II in predicting
mortality in Indian patients, suggesting both under-prediction and
over-prediction however limited data exists for the validation of the STS as
well as EuroSCORE II in the Indian population.
In light of the
challenges faced by tertiary cardiac centres in India, which cater to a growing
number of patients with valvular heart diseases, the present study proposes a
prospective observational analysis of valve surgery patients at a specific
centre. The study will be conducted over a period of 1 year including a sample
size of 200 patients undergoing cardiac valvular surgeries. Preoperative STS score will be calculated using https://riskcalc.sts.org/stswebriskcalc/calculate and EuroSCOREII will be calculated using calculator available on https://www.euroscore.org/index.php?Id=17. Other observations will be patient BMI, duration since first presenting symptom in the patient,
aortic cross clamp time and total CPB time, VIS score for inotropic support
after surgery, number of days for postoperative mechanical ventilation, need
for reexploration, days to discharge from ICU and whether the patient had death
or discharge from hospital. |