| CTRI Number |
CTRI/2024/10/075889 [Registered on: 25/10/2024] Trial Registered Prospectively |
| Last Modified On: |
24/10/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Comparing lactate (blood sample) and diastolic shock index (calculated from heart rate and diastolic blood pressure available from monitor)in patients admitted in icu with septic shock(condition with low blood pressure with a source of infection) to predict outcomes |
|
Scientific Title of Study
|
Comparison Of Diastolic Shock Index With Lactates In Predicting Outcomes In Septic Shock - A Prospective 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 |
Arun Kumaar |
| Designation |
Registrar (Academic) |
| Affiliation |
Virinchi Hospital |
| Address |
Dept of Critical Care Medicine
Medical intensive care unit
Third floor
Virinchi Hospital
Banjara Hills road no 1
Hyderabad
-
Hyderabad
TELANGANA
500034
India |
| Phone |
9944357333 |
| Fax |
- |
| Email |
arundec06@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Arun Kumaar |
| Designation |
Registrar (Academic) |
| Affiliation |
Virinchi Hospital |
| Address |
Dept of Critical Care Medicine
Medical intensive care unit
Third floor
Virinchi Hospital
Banjara Hills road no 1
Hyderabad
-
Hyderabad
TELANGANA
500034
India |
| Phone |
9944357333 |
| Fax |
- |
| Email |
arundec06@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Arun Kumaar |
| Designation |
Registrar (Academic) |
| Affiliation |
Virinchi Hospital |
| Address |
Dept of Critical Care Medicine
Medical intensive care unit
Third floor
Virinchi Hospital
Banjara Hills road no 1
Hyderabad
-
Hyderabad
TELANGANA
500034
India |
| Phone |
9944357333 |
| Fax |
- |
| Email |
arundec06@gmail.com |
|
|
Source of Monetary or Material Support
|
| Virinchi Hospital
Banjara Hills road no 1
Hyderabad, Telengana 500034
India |
|
|
Primary Sponsor
|
| Name |
Virinchi Hospital |
| Address |
Dept of critical care medicine Virinchi Hospital Banjara Hills road 1
Hyderabad
TELANGANA
500034
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 B Saroj Kumar Prusty |
Virinchi Hospital |
Dept of Critical Care Medicine
Medical intensive care unit
Third floor
Virinchi Hospital
Banjara Hills road no 1
Hyderabad
Hyderabad
TELANGANA |
9440721690
sarojprusty1@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R578||Other shock, |
|
|
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 |
Adult patients with septic shock as per sepsis-3 definition before initiation of vasopressors
|
|
| ExclusionCriteria |
| Details |
Those patients of septic shock presenting to ER/ICU with vasopressors
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
predictor of mortality
|
28 day mortality
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Number of vasopressor days
2. Incidence of acute kidney injury
3. ICU length of stay
|
at 28 days |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
04/11/2024 |
| 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 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
|
Once diagnosis of septic shock is made upon satisfying our inclusion criteria, Diastolic shock index will be calculated and serum lactates will be analysed. Demographic profile and underlying comorbidities, etiology of sepsis will be noted. Rest of the management will be un-interrupted by the investigator |