Hemodynamic Impact of Cytosorb and CKRT in Children With Septic Shock

Septic Shock Clinical Trial

— PedCyto  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05658588
• Other study ID #: AR-GB01
• Status: Completed
• Phase: N/A
• Start date: September 1, 2019
• Est. completion date: October 1, 2021

Study information

• Verified date: December 2022
• Source: Ospedale Pediatrico Bambin Gesù
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: October 1, 2021
• Est. primary completion date: October 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 17 Years

Eligibility

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.

Related Conditions & MeSH terms

• Septic Shock
• Shock
• Shock, Septic

Intervention

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

Locations

Country	Name	City	State
Italy	Gabriella Bottari	Rome

Sponsors (1)

Lead Sponsor	Collaborator
Ospedale Pediatrico Bambin Gesù

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Organ dysfunction change	changes in PELOD-2 score	96 hours
Other	Biomarkers of infection change	time-course of C-Reactive Protein, procalcitonin	96 hours
Other	Perfusion indexes change	Change lactate, PCO2 gap baseline	96 hours
Other	Mortality	Mortality at 28 days, at PICU and hospital discharge	90 days
Primary	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	Changes in hemodynamic parameters	changes in CI, SVRI, systolic pressure - Psys, diastolic pressure - Pdia, and mean pressure	96 hours