Health Condition 1: A419- Sepsis, unspecified organism
Conditions
Interventions
Intervention1: Nil: Nil
Control Intervention1: Nil: Nil
Control Intervention2: Nil: Nil
Sponsors
Directorate of Research
Department of Microbiology Kasturba Medical College
Eligibility
Inclusion criteria
Inclusion criteria: Patients hospitalized in intensive care units for sepsis. Case definition: Sepsis group: · Sepsis is defined as life-threatening organ dysfunction caused by a dysregulated host response to infection. · Organ dysfunction can be identified as an acute change in total SOFA score =2 points consequent to the infection. · The baseline SOFA score can be assumed to be zero in patients not known to have preexisting organ dysfunction. Control group: · Age matched individuals (± 5 years) with no known co-morbidities and living in the same locality as that of the sepsis group. · No history of previous hospitalization in the past 6 months · No history of consumption of antibiotics in the past 6 months.
Exclusion criteria
Exclusion criteria: Sepsis group: Inability to obtain consent from the patient or next of kin. Pregnant or breastfeeding women. Age of the participant is less than 18 years. Patients with "withdraw of care" decision at the time of inclusion. Patients with restricted liberty or under legal protection. Second admission to ICU or previous enrollment in a study (within same hospital admission). Transfer from other hospital ICUs (if stay was greater than 24 hours). Control group: History of hospitalisation and antibiotic consumption in the past 6 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Difference in gut microbiome diversity (Shanon and Observed index) between sepsis and control group. Alteration in relative abundance of gut microbiome in sepsis patients.Timepoint: Assessment will done within 24 hours of admission to ICU and 4th day after admission to ICU. | — |
Secondary
| Measure | Time frame |
|---|---|
| • Difference in gut microbiome alpha diversity (Shannon index and Observed index) between sepsis and control groups. • Alterations of the relative abundance of the gut microbiome among sepsis cases at different time points. Timepoint: At end of study. | — |
Countries
India
Contacts
Public ContactDr Chiranjay Mukhopadhyay
Manipal Academy of Higher Education
Outcome results
None listed