| CTRI Number |
CTRI/2025/01/079718 [Registered on: 29/01/2025] Trial Registered Prospectively |
| Last Modified On: |
27/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Comparison of Diastolic Shock Index and mortality in intensive care unit patients admitted with septic shock |
|
Scientific Title of Study
|
Diastolic Shock Index and clinical outcomes in patients with Septic Shock |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
S Priyadharshan |
| Designation |
Post graduate Resident |
| Affiliation |
Department of critical care medicine, Apollo Main Hospital chennai |
| Address |
Department of critical care medicine Apollo main hospital Greams lane Thousand lights chennai
Chennai
TAMIL NADU
600006
India |
| Phone |
6374009621 |
| Fax |
|
| Email |
drspriyadharshan@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
C Vignesh |
| Designation |
Senior Consultant |
| Affiliation |
Department of critical care medicine, Apollo Main Hospital chennai |
| Address |
Department of critical care medicine, Apollo Main Hospital Greams lane Thousand lights chennai
Chennai
TAMIL NADU
600006
India |
| Phone |
9884215326 |
| Fax |
|
| Email |
vignesh.c.able@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
R Balaji |
| Designation |
Consultant |
| Affiliation |
Department of critical care medicine, Apollo Main Hospital chennai |
| Address |
Department of critical care medicine, Apollo Main Hospital Greams lane Thousand lights chennai
Chennai
TAMIL NADU
600006
India |
| Phone |
8098010637 |
| Fax |
|
| Email |
balajirajaram@icuconsultants.com |
|
|
Source of Monetary or Material Support
|
| Department of critical care medicine Apollo Main Hospital Greams lane Thousand lights chennai 600006.Tamilnadu,India |
|
|
Primary Sponsor
|
| Name |
SPriyadharshan |
| Address |
Department of critical care medicine Apollo Main Hospital Greams lane Thousand lights chennai 600006 Tamilnadu India |
| 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 |
| S Priyadharshan |
Apollo Main Hospital |
Department of critical care medicine MDCCCU(multidisciplinary critical care unit) second floor
Chennai
TAMIL NADU |
6374009621
drspriyadharshan@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional ethical committe-Biomedical Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: R652||Severe sepsis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
All Patients admitted in intensive care unit with septic shock(sepsis 3.0 guidelines) |
|
| ExclusionCriteria |
| Details |
Pregnancy
Patients on Permanent Pacemaker
Presence of arrythmia |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Association between Diastolic Shock Index and IN Hospital mortality |
4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Association between Diastolic Shock Index &
1.Duration of ICU stay
2.Mechanical Ventilation free days
3.Vasopressor free days
4.Requirement of new renal replacement therapy |
4 weeks |
|
|
Target Sample Size
|
Total Sample Size="225"
Sample Size from India="225"
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)
|
10/02/2025 |
| 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="1"
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
|
In patients admitted with sepsis ,there are various predictors of outcome . In our study we calculated DSI -Diastolic shock index(Heart rate/Diastolic Bp) at the time of admission and 6 hours after admission.DSI is compared with mortality, duration of icu stay,duration of mechanical ventilation in all patients admitted with septic shock. It is a prospective observational study. |