Health Condition 1: B95-B97- Bacterial and viral infectious agents
Conditions
Interventions
Intervention1: Nil: Nil
Intervention2: Nil: Nil
Intervention3: Nil: Nil
Sponsors
AIIMS JODHPUR
Eligibility
Inclusion criteria
Inclusion criteria: 1. Adults aged more than 18 years 2. Diagnosed with sepsis based on Sepsis-3 criteria: life-threatening organ dysfunction caused by a dysregulated host response to infection, indicated by an increase in the SOFA score of more than 2. 3. Admisssion to the ICU within the past 24 hrs
Exclusion criteria
Exclusion criteria: 1. Autoimmune/inflammatory conditions 2. Known or suspected immunosuppressive conditions, including HIV/AIDS with CD4 count less than 200 Ongoing chemotherapy Organ or bone marrow transplant recipients on immunosuppressants 3. Pregnancy or lactation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To develop and internally validate a multivariable prognostic model incorporating serial serum IL-1R2 measurements at day 0 and 5 alongside standard clinical severity scores (SOFA) to predict 28-day all-cause mortality, and to rigorously evaluate the incremental discriminatory and reclassification value of IL-1R2Timepoint: outcome assessed at 4 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To assess the correlation between IL-1R2 levels & established severity scores, including: SOFA (Sequential Organ Failure Assessment) score APACHE II (Acute Physiology & Chronic Health Evaluation II) score Timepoint: outcome assessed at 4 weeks;To determine the prognostic value of IL1R2 for predicting outcomes such as ICU length of stay, need for vasopressors, or mortality.Timepoint: outcome assessed at 4 weeks;To evaluate the association between IL-1R2 levels & ICU length of stay (ICU-LOS).Timepoint: outcome assessed at 8 weeks;To determine whether IL-1R2 levels can predict the need for vasopressor support.Timepoint: outcome assessed at 4 weeks;To examine the predictive value of IL-1R2 for progression from sepsis to septic shock.Timepoint: outcome assessed at 4 weeks;To explore the dynamic changes in IL-1R2 levels & their association with patient outcomes.Timepoint: outcome assessed at 4 weeks;To identify & characterize distinct sepsis recovery subphenotypes through Group-Based Trajectory Modeling (GBTM) of longitudinal IL-1R2 expression patterns (measured on Days 0, 5), & to determine the association of these specific trajectories with the development of profound immune paralysis, secondary nosocomial infections, & prolonged vasopressor dependence.Timepoint: outcome assessed at 4 weeks | — |
Countries
India
Contacts
Public ContactDr. Darshan BK
AIIMS JODHPUR
Outcome results
None listed