| CTRI Number |
CTRI/2024/09/074301 [Registered on: 24/09/2024] Trial Registered Prospectively |
| Last Modified On: |
14/09/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Retrospective study |
| Study Design |
Other |
|
Public Title of Study
|
Outcome in terms death and complications after exposure to drugs that stimulate the heart following cardiac surgery |
|
Scientific Title of Study
|
Vasoactive-Inotropic Score for prediction of mortality and morbidity in patients undergoing cardiac surgery |
| 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 Raghu K |
| Designation |
Senior Resident |
| Affiliation |
Govt Of Goa |
| Address |
Department of Cardiac Anaesthesiology
Goa Medical College, Bambolim
north goa, goa state
india
North Goa
GOA
403202
India |
| Phone |
08322495010 |
| Fax |
|
| Email |
raghunandan007@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sunil Chandra Vidya Sagar M |
| Designation |
Prof and Head Dept of Cardiac Anesthesia |
| Affiliation |
Goa Medical College |
| Address |
Department of Cardiac Anaesthesiology
Goa Medical College, Bambolim
North Goa
GOA
403202
India |
| Phone |
7414984149 |
| Fax |
|
| Email |
drsunilsagar@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Raghu K |
| Designation |
Senior Resident |
| Affiliation |
Goa Medical College |
| Address |
Department of Cardiac Anaesthesiology
Goa Medical College, Bambolim
GOA
403202
India |
| Phone |
08322495010 |
| Fax |
|
| Email |
raghunandan007@gmail.com |
|
|
Source of Monetary or Material Support
|
| Goa Medical College
Bambolim
North Goa District
goa state
403202
Goa State 403202
08322495011 |
|
|
Primary Sponsor
|
| Name |
Dr Raghu K |
| Address |
Department of Cardiac Anaesthesiology
Goa Medical College, Bambolim
north goa district
goa state 403202
|
| 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 Raghu K |
Goa Medical College Hospital Bambolim |
Ward No 34, Cardiothoracic and vascular surgery block, Goa Medical College, Bambolim
North Goa
GOA |
08322495010
raghunandan007@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC Goa Medical College |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I251||Atherosclerotic heart disease of native coronary artery, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Patients whose age more than 18 years underwent elective cardiac surgeries requiring CPB. |
|
| ExclusionCriteria |
| Details |
Patients less than 18 years, patients who underwent aortic arch surgeries and patients who have taken for re-explorative surgeries |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| explore the association of the VIS max and mortality |
24 th hour post operatively |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| investigate the association of VIS max at 24th hour with length of ICU stay, Acute kidney injury & Cerebrovascular event. |
VIS max meaasured at 24th hour post opertaively |
|
|
Target Sample Size
|
Total Sample Size="287"
Sample Size from India="287"
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)
|
29/09/2024 |
| 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="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
|
severity of illness and outcomes of the patients admitted in ICU are often estimated using scoring system. the scoring system include APACHE II, SAPS II/III, SOFA score. however such scoring system to assess the outcome following cardiac surgery limited. Vasoactive Ionotropic score (VIS) which is the sum of all administered inotropes and vasconstrictors is successfully tested for predicting the outcomes in pedaitric cardiac surgery. There is limited data regarding predictive performance of VIS scoring system in adult population. Hence we decided to conduct the study to explore the association of VIS score and mortality.
|