Hemodynamic Impact of Cytosorb and CKRT in Children With Septic Shock

Not Applicable

Completed

• Conditions: Septic Shock
• Interventions: Device: Cytosorb

• Registration Number: NCT05658588
• Lead Sponsor: Ospedale Pediatrico Bambin Gesù

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.

Study Timeline

• Study Start: 2019-09-01
• Primary Completion: 2021-10-01
• Study Completion: 2021-10-01
• Status Verified: 2022-12
• Study First Submitted: 2022-12-04
• Study First Submitted QC: 2022-12-13
• Last Update Submitted: 2022-12-13
• Study First Posted: 2022-12-21
• Last Update Posted: 2022-12-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 17

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Hemoperfusion and CKRT in pediatric septic shock	Cytosorb	Hemoperfusion with Cytosorb in combination with CKRT

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Changes in hemodynamic parameters	96 hours	changes in CI, SVRI, systolic pressure - Psys, diastolic pressure - Pdia, and mean pressure

Trial Locations

Locations (1)

Gabriella Bottari; 🇮🇹 Rome, Italy