Hemodynamic Impact of Cytosorb and CKRT in Children With Septic Shock (PedCyto)

Ospedale Pediatrico Bambin Gesù

Status: Completed

Conditions: Septic Shock

Treatments: Device: Cytosorb

Study type: Interventional

Funder types: Other

Identifiers

NCT05658588

AR-GB01

Details and patient eligibility

About

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

Full 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.

Enrollment: 17 patients

Sex: All

Ages: 1 to 17 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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17 participants in 1 patient group

Hemoperfusion and CKRT in pediatric septic shock

Experimental group

Description:

Hemoperfusion with Cytosorb in combination with CKRT

Treatment:

Device: Cytosorb