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

Sponsor

Ospedale Pediatrico Bambin Gesù (Other)

Overall Status

Completed

CT.gov ID

NCT05658588

Collaborator

(none)

Enrollment

Location

Arm

Actual Duration (Months)

0.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Septic Shock	Device: Cytosorb	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

17 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Intervention Model Description:

a two-stage plan by Simona two-stage plan by Simon

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Sep 1, 2019

Actual Primary Completion Date :

Oct 1, 2021

Actual Study Completion Date :

Oct 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Hemoperfusion and CKRT in pediatric septic shock Hemoperfusion with Cytosorb in combination with CKRT	Device: Cytosorb 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 Other Names: CKRT

Arm

Intervention/Treatment

Experimental: Hemoperfusion and CKRT in pediatric septic shock

Hemoperfusion with Cytosorb in combination with CKRT

Device: Cytosorb

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

Other Names:

CKRT

Outcome Measures

Primary Outcome Measures

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

Changes in hemodynamic parameters [96 hours]
changes in CI, SVRI, systolic pressure - Psys, diastolic pressure - Pdia, and mean pressure

Other Outcome Measures

Organ dysfunction change [96 hours]
changes in PELOD-2 score
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

1 Year to 17 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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%