Hemodynamic Impact of Cytosorb and CKRT in Children With Septic Shock

Study Overview
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Brief Summary
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Impact of the hemoadsorption with Cytosorb on hemodynamic in pediatric patients with septic shock: a prospectic pediatric pilot study

Detailed Description
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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.

Official Title
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Impact of Cytosorb and CKRT on Hemodynamics in Pediatric Patients With Septic Shock: the PedCyto Study

Conditions
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Septic Shock

Intervention / Treatment
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* Device: Cytosorb


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Children weighing ≥ 10 kg Septic shock as defined by the International Pediatric Consensus Conference 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.

Ages Eligible for Study
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Minimum Age: 1 Year
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: a two-stage plan by Simon
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hemoperfusion and CKRT in pediatric septic shock<br>Hemoperfusion with Cytosorb in combination with CKRT | Device: Cytosorb<br>* 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<br>* Other names: CKRT;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vasopressors and inotropes reduction | Proportion of patients who achieved a significant reduction in vasopressors or inotropes dose from baseline to the end of treatment. | 96 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in hemodynamic parameters | changes in CI, SVRI, systolic pressure - Psys, diastolic pressure - Pdia, and mean pressure | 96 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hemoperfusion, Pediatric Septic Shock, Blood Purification, AKI, Pediatric Critical Care, CKRT