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

Primary Purpose

Septic Shock

Status
Completed
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Cytosorb
Sponsored by
Ospedale Pediatrico Bambin Gesù
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Septic Shock focused on measuring Pediatric Septic Shock, Blood Purification, AKI, Pediatric Critical Care, Hemoperfusion, CKRT

Eligibility Criteria

1 Year - 17 Years (Child)All SexesDoes not accept 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% Exclusion Criteria: Refused consensus by parents Concomitant use of other extracorporeal blood purification techniques.

Sites / Locations

  • Gabriella Bottari

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Hemoperfusion and CKRT in pediatric septic shock

Arm Description

Hemoperfusion with Cytosorb in combination with CKRT

Outcomes

Primary Outcome Measures

Vasopressors and inotropes reduction
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
changes in CI, SVRI, systolic pressure - Psys, diastolic pressure - Pdia, and mean pressure

Full Information

First Posted
December 4, 2022
Last Updated
December 13, 2022
Sponsor
Ospedale Pediatrico Bambin Gesù
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1. Study Identification

Unique Protocol Identification Number
NCT05658588
Brief Title
Hemodynamic Impact of Cytosorb and CKRT in Children With Septic Shock
Acronym
PedCyto
Official Title
Impact of Cytosorb and CKRT on Hemodynamics in Pediatric Patients With Septic Shock: the PedCyto Study
Study Type
Interventional

2. Study Status

Record Verification Date
December 2022
Overall Recruitment Status
Completed
Study Start Date
September 1, 2019 (Actual)
Primary Completion Date
October 1, 2021 (Actual)
Study Completion Date
October 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ospedale Pediatrico Bambin Gesù

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Septic Shock
Keywords
Pediatric Septic Shock, Blood Purification, AKI, Pediatric Critical Care, Hemoperfusion, CKRT

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
a two-stage plan by Simon
Masking
None (Open Label)
Allocation
N/A
Enrollment
17 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Hemoperfusion and CKRT in pediatric septic shock
Arm Type
Experimental
Arm Description
Hemoperfusion with Cytosorb in combination with CKRT
Intervention Type
Device
Intervention Name(s)
Cytosorb
Other Intervention Name(s)
CKRT
Intervention Description
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
Primary Outcome Measure Information:
Title
Vasopressors and inotropes reduction
Description
Proportion of patients who achieved a significant reduction in vasopressors or inotropes dose from baseline to the end of treatment.
Time Frame
96 hours
Secondary Outcome Measure Information:
Title
Changes in hemodynamic parameters
Description
changes in CI, SVRI, systolic pressure - Psys, diastolic pressure - Pdia, and mean pressure
Time Frame
96 hours
Other Pre-specified Outcome Measures:
Title
Organ dysfunction change
Description
changes in PELOD-2 score
Time Frame
96 hours
Title
Biomarkers of infection change
Description
time-course of C-Reactive Protein, procalcitonin
Time Frame
96 hours
Title
Perfusion indexes change
Description
Change lactate, PCO2 gap baseline
Time Frame
96 hours
Title
Mortality
Description
Mortality at 28 days, at PICU and hospital discharge
Time Frame
90 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Gabriella Bottari
City
Rome
ZIP/Postal Code
00151
Country
Italy

12. IPD Sharing Statement

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Hemodynamic Impact of Cytosorb and CKRT in Children With Septic Shock

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