| CTRI Number |
CTRI/2025/03/082824 [Registered on: 19/03/2025] Trial Registered Prospectively |
| Last Modified On: |
11/03/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
Comparing how well the qSOFA, SIRS, and SOFA tests predict the risk of death in people with sepsis. |
|
Scientific Title of Study
|
A Prospective observational study Comparison of qSOFA score, SIRS criteria and SOFA scores as predictors of mortality in patient with sepsis. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
D Indhumathi |
| Designation |
Post Graduate MSC Critical care technology |
| Affiliation |
SRM Medical college hospital and research center |
| Address |
Room number 22 4th floor Department of critical care medicine
SRM Medical College Hospital SRM Nagar potheri
Room number 22 4th floor Department of critical care medicine
SRM Medical College Hospital SRM Nagar potheri
Kancheepuram
TAMIL NADU
603203
India |
| Phone |
8925752459 |
| Fax |
|
| Email |
indhudeva0607@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr A S Dheepak kumaran |
| Designation |
Assistant Professor |
| Affiliation |
SRM Medical College Hospital and Research Centre |
| Address |
Room number 22 4th floor Department of critical care medicine
SRM Medical College Hospital SRM Nagar potheri
Room number 22 4th floor Department of critical care medicine
SRM Medical College Hospital SRM Nagar potheri
Chennai
TAMIL NADU
603203
India |
| Phone |
9073934944 |
| Fax |
|
| Email |
dheepaka@srmist.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr A S Dheepak kumaran |
| Designation |
Assistant Professor |
| Affiliation |
SRM Medical College Hospital and Research Centre |
| Address |
Room number 22 4th floor Department of critical care medicine
SRM Medical College Hospital SRM Nagar potheri
Room number 22 4th floor Department of critical care medicine
SRM Medical College Hospital SRM Nagar potheri
Chennai
TAMIL NADU
603203
India |
| Phone |
9073934944 |
| Fax |
|
| Email |
dheepaka@srmist.edu.in |
|
|
Source of Monetary or Material Support
|
| SRM Medical College Hospital and Research Centre, SRM nagar, potheri, Chengalpattu, Tamilnadu - 603203 |
|
|
Primary Sponsor
|
| Name |
NIL |
| Address |
NIL |
| Type of Sponsor |
Other [NIL] |
|
|
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 |
| D Indhumathi |
SRM Medical College Hospital and Research Centre |
Room number 22 4th floor Department of critical care medicine SRM Medical College Hospital SRM Nagar potheri
Chennai
TAMIL NADU |
8925752459
indhudeva0607@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SRM Medical College Hospital and Research Centre Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: A498||Other bacterial infections of unspecified site, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1 Patients diagnosed with sepsis and septic shock
2 Patients above 18 years of age
3 ASA I and ASA II patients are included |
|
| ExclusionCriteria |
| Details |
1 Patients below 18 years and above 80 years of age
2 Patients not willing to participate in the study
3 Trauma patients are not included |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the SOFA,SIRS and qSOFA scores and to predict mortality |
Day 1 Day 3 Day 5 and Day 7 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To find the associated comorbidity related to sepsis & cause for mortality |
Day 1 Day 3 Day 5 & Day 7 |
|
|
Target Sample Size
|
Total Sample Size="109"
Sample Size from India="109"
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)
|
27/03/2025 |
| 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="0"
Months="4"
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
|
All patients who are diagnosed with sepsis or septic shock at the time of hospital admission are enrolled in this study. Demographic details like age,gender will be recorded along with associated co morbidities. Blood investigation like CBC,LFT,RFT are sent on the day of admission and treatment started as per hospital protocol. Patients are admitted in icu . SOFA score, SIRS status and qSOFA score will be noted. Additional details like ventilator support or ionotropic supports are recorded. Patients are followed up on alternate days for 1 week. After discharge patient are contacted through telephone and their health condition is enquired. In case of mortality at home, date of death will be recorded. Patients are followed up till end point, that is mortality or recovery. |