| CTRI Number |
CTRI/2026/03/106621 [Registered on: 20/03/2026] Trial Registered Prospectively |
| Last Modified On: |
14/11/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
How Sepsis Affects the Brain: A Brain Monitoring device (FNIRS) based study to compare differences in frontal brain area oxyhemoglobin level in patients with and without brain dysfunction due to infection |
|
Scientific Title of Study
|
Functional near-infrared spectroscopy-based assessment of prefrontal cortical activity in sepsis associated encephalopathy |
| Trial Acronym |
FNPAS |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Santosh Parajuli |
| Designation |
Senior Resident |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
Room number 5011, Department of Anaesthesiology Pain medicine and Critical Care, 5th floor, Ward Block, AIIMS, New Delhi
New Delhi
DELHI
110029
India |
| Phone |
7303015590 |
| Fax |
|
| Email |
santoshparajuli2051@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Puneet Khanna |
| Designation |
Professor |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
Room number 5008A, Department of Anaesthesiology Pain medicine and Critical Care, 5th floor, Ward Block, AIIMS, New Delhi
Room number 5011, Department of Anaesthesiology Pain medicine and Critical Care, 5th floor, Ward Block, AIIMS, New Delhi
New Delhi
DELHI
110029
India |
| Phone |
9873106516 |
| Fax |
|
| Email |
k.punit@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Puneet Khanna |
| Designation |
Professor |
| Affiliation |
All India Institute of Medical Sciences |
| Address |
Room number 5008A, Department of Anaesthesiology Pain medicine and Critical Care, 5th floor, Ward Block, AIIMS, New Delhi
New Delhi
DELHI
110029
India |
| Phone |
9873106516 |
| Fax |
|
| Email |
k.punit@yahoo.com |
|
|
Source of Monetary or Material Support
|
| All India Institute of Medical Sciences, Ansari Nagar, New Delhi, India, 110029 |
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences |
| Address |
Ansari Nagar, New Delhi, India, 110029 |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
| Name |
Address |
| All India Institute of Medical Sciences |
Ansari Nagar, New Delhi |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Santosh Parajuli |
All India Institute of Medical Sciences |
Room number 5011, Department of Anaesthesiology Pain medicine and Critical Care, 5th floor, Ward Block, AIIMS, New Delhi, India, 110029
New Delhi
DELHI |
7303015590
santoshparajuli2051@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institute Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: B968||Other specified bacterial agents as the cause of diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
18 to 70 years
Admitted to the ICU within 24 hours of having been diagnosed with septic shock defined by Sepsis 3 consensus guidelines as a “Suspected or confirmed source of infection with
Sequential organ failure assessment more than or equal to 2 and
Shock defined as hypotension requiring persistent vasopressor therapy to maintain mean arterial pressure more than 65 mmHg and serum lactate levels greater than 2 mmol per litre despite adequate initial fluid resuscitation at least 30ml per kilogram of ideal body weight
SAE diagnosed with cerebral dysfunction Glasgow Coma Scale less than or equal to 14 or with delirium caused by systemic responses to infections without structural abnormality, cerebral nervous system infection, and encephalopathy due to other causes such as hepatic, uremic, and toxic |
|
| ExclusionCriteria |
| Details |
Patients diagnosed with other causes of encephalopathy (hepatic, toxic, uremic, hypoxic)
A pre-ICU diagnosis of cognitive dysfunction as indicated by their medical records on admission, or a primary central nervous system diagnosis like a cerebrovascular accident, meningitis, seizure disorder, psychiatric disorder, hypoxic encephalopathy post cardiac arrest.
Life-threatening bleeding, the presence of hemorrhagic shock, as judged by research or treating clinicians
Burns, Pregnancy
Referral from or treated at other healthcare facilities
Readmission to ICU
Withdrawal of consent
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To compare the cerebral oxyhemoglobin concentration in prefrontal cortex detected by fNIRS in patients with sepsis associated encephalopathy and patients without sepsis associated encephalopathy |
Day 1 and Day 3 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
To compare difference in following parameters in patients with and without sepsis associated encephalopathy
Age
Gender
APACHE II score
SOFA score
Serum Sodium level
Serum albumin level |
Day 1 to Day 28 |
|
|
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)
|
04/04/2026 |
| 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="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
|
This observational study will help in identification of changes in cerebral oxygenation in prefrontal cortex area of patients with sepsis associated encephalopathy which will help to further support the concept that sepsis associated encephalopathy results in declining of functional brain activity. |