| CTRI Number |
CTRI/2025/02/079863 [Registered on: 03/02/2025] Trial Registered Prospectively |
| Last Modified On: |
30/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
qSOFA Scores and Sepsis Outcomes in Neurology & Neurosurgery Patients |
|
Scientific Title of Study
|
A study to assess the qSOFA scores and its association with clinical signs of sepsis and selected outcomes in patient admitted in Neurology and Neurosurgery ward at AIIMS, New Delhi |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Neha Sah |
| Designation |
MSc. Nursing Student |
| Affiliation |
All India Institute of Medical Sciences, New Delhi |
| Address |
Room no.9, ground floor, College Of Nursing, All India Institute of Medical Sciences, New Delhi
South West
DELHI
110029
India |
| Phone |
9354534028 |
| Fax |
|
| Email |
nehasah1704@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Ms Sibi Riju |
| Designation |
Associate Professor |
| Affiliation |
All India Institute of Medical Sciences, New Delhi |
| Address |
Room no. 9, ground floor, College Of Nursing, All India Institute of Medical Sciences, New Delhi
South West
DELHI
110029
India |
| Phone |
9958879808 |
| Fax |
|
| Email |
sibiriju@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Ms Sibi Riju |
| Designation |
Associate Professor |
| Affiliation |
All India Institute of Medical Sciences, New Delhi |
| Address |
Room no. 9, ground floor, College Of Nursing, All India Institute of Medical Sciences, New Delhi
South West
DELHI
110029
India |
| Phone |
9958879808 |
| Fax |
|
| Email |
sibiriju@gmail.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences, Ansari Nagar, New Delhi, pin code- 110029 |
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences New Delhi |
| Address |
College of Nursing, All India Institute of Medical Sciences, Ansari Nagar, New Delhi, pin code- 110029 |
| 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 Deepti Vibha |
All India Institute of Medical Sciences, New Delhi |
7th Floor, Room no. 707 Neurology Department, Cardio Neuro Centre , All India Institute of Medical Sciences, New Delhi, 110029
South West
DELHI
South West
DELHI |
9968859848
deeptivibha@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee for Postgraduate Research, All India Institute of Medical Sciences, New Delhi |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G00-G99||Diseases of the nervous system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
Inclusion criteria for patients admitted in Neurology:
Patient admitted directly from emergency or via non- emergency admissions.
Inclusion criteria for patients admitted in Neurosurgery:
Post- operative patients.
|
|
| ExclusionCriteria |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To find out the association of qSOFA scores with clinical signs of sepsis among patients admitted in neuroscience center.
|
4 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To find out the association of qSOFA scores with selected patient outcomes |
4 weeks |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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="0"
Months="6"
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
|
The study aims to evaluate the relationship between
qSOFA scores and clinical signs of sepsis among patients admitted to the
Neurology and Neurosurgery ward at AIIMS, New Delhi. Additionally, it seeks to
determine the association between qSOFA scores and selected patient outcomes.
The primary research question investigates how qSOFA scores correlate with
clinical signs of sepsis and key patient outcomes in this specific patient
population.
|