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An observational trial to study the effect of fluid accumulation on acute confusional state in patients admitted to the intensive care unit(ICU) with severe infection using CAM-ICU score and a non-ivasive monitor called functional near-infrared spectroscopy (fNIRS) for forebrain mapping.

Effect of cumulative fluid balance on delirium predicted by CAM-ICU and functional near-infrared spectroscopy (fNIRS) guided mapping of frontal cortex in critically ill patients with septic shock- a prospective observational study. - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2024/02/062440
Enrollment
132
Registered
2024-02-08
Start date
Unknown
Completion date
Unknown
Last updated
2024-03-04

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: Not applicable as observational study: Not applicable as observational study Intervention2: NIL: NIL Control Intervention1: Not applicable as observational study: Not applicable as obse

Sponsors

AIIMS
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 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 (SOFA) more than or equal to 2 and shock. Shock is defined as hypotension requiring persistent vasopressor therapy to maintain mean arterial pressure (MAP) of more than 65 mmHg and serum lactate levels greater than 2 mmol per L despite adequate initial fluid resuscitation (at least 30ml per kg of IBW).

Exclusion criteria

Exclusion criteria: Patients on short term mechanical ventilation less than 48 hours. A pre-ICU diagnosis of cognitive dysfunction as indicated by their medical records on admission, or a primary central nervous system diagnosis like cerebrovascular accident, meningitis, seizure disorder, psychiatric disorder, hypoxic encephalopathy post cardiac arrest. Death before assessment of ICU-delirium within 3 days of ICU admission. 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. Patients with a likely extracerebral source of serum S100B elevation (e.g., severe disabling neuromuscular disorders, severe burns, advanced malignancy, polytrauma, and chronic renal failure). Readmission to ICU. Withdrawal of consent.

Design outcomes

Primary

MeasureTime frame
To analyze the correlation of day-7 cumulative fluid balance with the incidence of delirium, during the first 7 days of ICU admission.Timepoint: From day 1 to day 7 after ICU admission

Secondary

MeasureTime frame
To assess the correlation of cumulative fluid balance with the average comatose (RASS -4 and-5) daysTimepoint: From day 1 to day 7 after ICU admission;To assess the correlation of cumulative fluid balance with the average days of delirium (CAM-ICU positive days) Timepoint: From day 1 to day 7 after ICU admission;To assess the correlation of cumulative fluid balance with the severity of delirium using CAM-ICU-7 Delirium Severity ScaleTimepoint: From day 1 to day 7 after ICU admission;To assess the effect of other risk factors of delirium.Timepoint: From day 1 to day 7 after ICU admission;To study the association of cumulative fluid balance with the changes in frontal cortex using fNIRS in patients with delirium.Timepoint: on day1, 4 and 7 after ICU admission

Countries

India

Contacts

Public ContactMeenupriya Arasu

All India Institute of Medical Sciences, New Delhi

dr.akhilsingh@gmail.com

Outcome results

None listed

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