Health Condition 1: A499- Bacterial infection, unspecified Health Condition 2: A488- Other specified bacterial diseases Health Condition 3: Y999- Unspecified external cause status
Conditions
Interventions
Intervention1: Mycobacterium w (Heat Killed)
: As an immunomodulator, the mycobacterium w (Mw) has improved outcomes for patients suffering from severe sepsis. It s innovation in Sepsis management and
Immuvac, Cadila Pharma, Ahmedabad, India) in the deltoid region for 3 consecutive days
Control Intervention1: Matching Placebo in similar vial: The active drug and matching placebo will be provided i
Sponsors
Rajendra Institute of Medical Sciences, Ranchi
Not secondary Sponsor
Eligibility
Inclusion criteria
Inclusion criteria: Patients with septic shock systolic blood pressure less than or equal to 90 mm Hg or the mean arterial pressure less than or equal to 65 mm Hg for at least one hour despite adequate fluid resuscitation or the use of vasopressors to maintain a systolic blood pressure or mean arterial pressure of more than 90 and more than 65 mm Hg, respectively
Exclusion criteria
Exclusion criteria: Pregnancy or lactating mother Gram-positive culture Only fungal infection as a source of sepsis Patients who received cardiopulmonary resuscitation Those on immunosuppressive therapy Those unwilling to provide informed consent
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary outcome: Vasopressor free days Timepoint: 28-days | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcome [Time Frame: 28-day]: Duration of antibiotic use New onset organ dysfunction- measured by delta SOFA (maximum minus baseline SOFA) Ventilator-free days Day off the mechanical ventilator Time-to-vasopressor withdrawal (number of days receiving vasopressor drugs) ICU length of stay Hospital length of stay New-onset infection (rate of secondary nosocomial infections) Timepoint: 28-days | — |
Countries
India
Contacts
Public ContactJay Prakash
Rajendra Institute of Medical Sciences
Outcome results
None listed