| CTRI Number |
CTRI/2024/02/062964 [Registered on: 21/02/2024] Trial Registered Prospectively |
| Last Modified On: |
17/02/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Prospective Observational Study |
| Study Design |
Other |
|
Public Title of Study
|
evaluating the power of the Diastolic shock index ( Heart rate / diastolic blood pressure) in predicting in-hospital death and length of hospital stay among patients undergoing emergency surgeries |
|
Scientific Title of Study
|
Evaluation of prognostic performance of diastolic shock index as a predictor of mortality in patients undergoing emergency, non-trauma, non-cardiac surgeries: A prospective observational study. |
| 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 Aloka Samantaray |
| Designation |
HOD dept of Anaesthesialogy |
| Affiliation |
Sri Venkateswaras Institute of Medical sciences |
| Address |
Department of Anaesthesiology, SVIMS, Valmiki circle, Tirupati,
Chittoor
ANDHRA PRADESH
517507
India |
| Phone |
9493547653 |
| Fax |
|
| Email |
aloksvims@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Aloka Samantaray |
| Designation |
HOD dept of Anaesthesialogy |
| Affiliation |
Sri Venkateswaras Institute of Medical sciences |
| Address |
Department of Anaesthesiology, SVIMS, Valmiki circle, Tirupati,
Chittoor
ANDHRA PRADESH
517507
India |
| Phone |
9493547653 |
| Fax |
|
| Email |
aloksvims@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Bharath kumar |
| Designation |
JR dept of Anaesthesialogy |
| Affiliation |
Sri Venkateswaras Institute of Medical sciences |
| Address |
Department of Anaesthesiology, SVIMS, Valmiki circle, Tirupati,
Chittoor
ANDHRA PRADESH
517507
India |
| Phone |
9491771356 |
| Fax |
|
| Email |
drbharath019@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Venkateswara Institute of Medical Sciences |
|
|
Primary Sponsor
|
| Name |
Sri Venkateswara Institute of Medical Sciences |
| Address |
Department of anaesthesiology, SVIMS, Valmiki circle, Tirupati,
chittoor Dt.
Chittoor
ANDHRA PRADESH
517507
India |
| Type of Sponsor |
Private hospital/clinic |
|
|
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 Aloka Samantaray |
Sri Venkateswara Institute of Medical Sciences |
Department of anaesthesiology, SVIMS, Valmiki circle, Tirupati,
chittoor Dt.
Chittoor
ANDHRA PRADESH
517507
India
Chittoor
ANDHRA PRADESH |
9493547653
aloksvims@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, SVIMS, Tirupati SRI VENKATESWARA INSTITUTE OF MEDICAL SCIENCES Alipiri Road SVIMS Campus Tirupati Chittoor Andhra Pradesh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: O||Medical and Surgical, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
nil |
nil |
| Comparator Agent |
nil |
nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
all adults under going emergency non cardiac non trauma surgeries |
|
| ExclusionCriteria |
| Details |
Pregnant and lactating mother
patients with rhythm disturbances and rate controlling drugs
Liver failure patients with child-pugh C
patient not willing to participate
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To determine a cut-off value for DSI using receiver operating characteristic (ROC) curve and compare DSI with other shock indices with AUC. |
AT time of induction of anaesthesia |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To compare DSI with other established shock indexes like systolic shock index, modified shock index and age shock index.
2.To evaluate post operative complications
1.Death
2.Need of mechanical ventilation
3.Organ failure( using SOFA score)
4.Inotrope and vasopressor requirement |
During in hospital stay |
|
|
Target Sample Size
|
Total Sample Size="75"
Sample Size from India="75"
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)
|
27/02/2024 |
| 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="3"
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
|
a sample size of 75 patients undergoing non-cardiac non-trauma emergency surgeries will be enrolled, and vitals of patients like heart rate blood pressure saturation respiratory rate will be recorded at the time of induction irrespective of the nature of anesthesia. Shock indices like Systolic shock index, modified shock index, age shock index, and diastolic shock index will be calculated and compared. fallow that length of hospital stay and in-hospital mortality will also be noted.
|