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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

Functional near-infrared spectroscopy-based assessment of prefrontal cortical activity in sepsis associated encephalopathy - FNPAS

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2026/03/106621
Enrollment
100
Registered
2026-03-20
Start date
Unknown
Completion date
Unknown
Last updated
2026-03-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: B968- Other specified bacterial agents as the cause of diseases classified elsewhere

Interventions

Intervention1: Nil: Nil

Sponsors

All India Institute of Medical Sciences
Lead Sponsor
All India Institute of Medical Sciences
Collaborator

Eligibility

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

MeasureTime frame
To compare the cerebral oxyhemoglobin concentration in prefrontal cortex detected by fNIRS in patients with sepsis associated encephalopathy and patients without sepsis associated encephalopathyTimepoint: Day 1 and Day 3

Secondary

MeasureTime frame
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 levelTimepoint: Day 1 to Day 28

Countries

India

Contacts

Public ContactPuneet Khanna

All India Institute of Medical Sciences

k.punit@yahoo.com9873106516

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Apr 4, 2026