Septic Shock
Conditions
Keywords
Pediatric Septic Shock, Blood Purification, AKI, Pediatric Critical Care, Hemoperfusion, CKRT
Brief summary
Impact of the hemoadsorption with Cytosorb on hemodynamic in pediatric patients with septic shock: a prospectic pediatric pilot study
Detailed description
Prospective interventional pilot study included children with septic shock, weight ≥ 10 Kgs and requiring continuous kidney replacement therapy. Cytosorb (CytoSorbents Inc, New Jersey, USA) cartridge was added to CKRT every 24 hours for a maximum of 96 hours. A control group of matched patients was also identified from an external database. The primary outcome of the study was the proportion of patients who achieved an equal or more than 50% relative reduction in vasopressors or inotropes dose from baseline to the end of treatment. Secondary outcomes included doses of vasopressors and inotropes, hemodynamic and biological changes, changes in severity scores and 28-day mortality.
Interventions
DEVICECytosorb
Cytosorb cartridge It is composed of polystyrene divinylbenzene and polyvinylpyrrolidone copolymers and targets molecules in the 5-50 kDa range, which includes the molecular mass of several cytokines
Sponsors
Ospedale Pediatrico Bambin Gesù
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
a two-stage plan by Simon
Eligibility
Sex/Gender
ALL
Age
1 Years to 17 Years
Healthy volunteers
No
Inclusion criteria
1. Children weighing ≥ 10 kg 2. Septic shock as defined by the International Pediatric Consensus Conference 3. Need for Continuous Renal Replacement Therapy (CRRT) = acute kidney injury defined by the KDIGO criteria (16) AND/OR fluid overload ≥ 10%
Exclusion criteria
* Refused consensus by parents * Concomitant use of other extracorporeal blood purification techniques.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Vasopressors and inotropes reduction | 96 hours | Proportion of patients who achieved a significant reduction in vasopressors or inotropes dose from baseline to the end of treatment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in hemodynamic parameters | 96 hours | changes in CI, SVRI, systolic pressure - Psys, diastolic pressure - Pdia, and mean pressure |
Other
| Measure | Time frame | Description |
|---|---|---|
| Biomarkers of infection change | 96 hours | time-course of C-Reactive Protein, procalcitonin |
| Perfusion indexes change | 96 hours | Change lactate, PCO2 gap baseline |
| Mortality | 90 days | Mortality at 28 days, at PICU and hospital discharge |
| Organ dysfunction change | 96 hours | changes in PELOD-2 score |
Countries
Italy
Outcome results
None listed