Health Condition 1: R652- Severe sepsis
Conditions
Interventions
Intervention1: Therapeutic Plasma Exchange: In Intervention arm
The children with Severe Sepsis will be initially stabilized with existing standard or care. Central venous access with double lumen h
Sponsors
Intramural Research Fund JIPMER
Eligibility
Inclusion criteria
Inclusion criteria: 1.Children aged 1 - 15 years with Severe Sepsis as diagnosed by the 2005 International Pediatric Sepsis Consensus Conference 2.Weight of the child >=8 kg 3.Vasoactive-Inotrope Score (VIS) less than 80 after initial resuscitation
Exclusion criteria
Exclusion criteria: 1.Children with suspected / confirmed atypical Hemolytic Uremic Syndrome, Thrombotic thrombocytopenic Purpura, Anti Glomerular Basement Membrane disease, Granulomatosis with Polyangitis, Systemic Lupus erythematosus, because of the potential efficacy of TPE in these conditions 2.Children with suspected/ proved intracranial hemorrhage. 3.Children with Severe Dengue 4.Children with Severe acute malnutrition (SAM) 5.Underlying diagnosis is life-limiting / treating team and /or parents opt for limited care 6.Children admitted under the care of other departments (CTVS, Neurosurgery etc)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine the effect of therapeutic plasma exchange as compared to existing standard of care, as assessed by a Composite Outcome Measure, in the treatment of children aged 1-15 years with severe sepsis. The occurrence of either of the following would qualify for the Composite outcome 1.All- cause mortality at D7 of PICU stay 2.Development of New or Progressive Multiorgan Dysfunction (NPMODS) within D7 of PICU stay Timepoint: Day 7 of PICU Stay | — |
Secondary
| Measure | Time frame |
|---|---|
| To compare trends of CRP , Ferritin, IL-6 between two groups on D1, D4 and D7Timepoint: Days 1, 4 and 7;To evaluate the feasibility of initiating Therapeutic Plasma Exchange within 6 hours of diagnosis of Severe Sepsis.Timepoint: 6 hours of Randomization;To evaluate the feasibility of safely administering the procedure by measuring the frequency of occurrence of a set of predetermined adverse events.Timepoint: Throughout intervention;To compare the all-cause mortality at 28 days between the two groups. Timepoint: Day 28 of PICU Stay;To compare the magnitude of change of Vasoactive-Inotropic Score (VIS) between the two groups in the first 7 daysTimepoint: Daily in the first 7 days;To compare the PELOD-2 scores at D7 between the two groups. Timepoint: Day 7 of Intervention | — |
Countries
India
Contacts
Public ContactSreedeep KS
Jawaharlal Institute of Postgraduate Medical Education and Research
Outcome results
None listed