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Hemodynamic Impact of Cytosorb and CKRT in Children With Septic Shock

NCT ID: NCT05658588

Last Updated: 2022-12-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

17 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-09-01

Study Completion Date

2021-10-01

Brief Summary

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

Detailed Description

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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.

Conditions

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Septic Shock

Keywords

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Pediatric Septic Shock Blood Purification AKI Pediatric Critical Care Hemoperfusion CKRT

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

a two-stage plan by Simon
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Hemoperfusion and CKRT in pediatric septic shock

Hemoperfusion with Cytosorb in combination with CKRT

Group Type EXPERIMENTAL

Cytosorb

Intervention Type DEVICE

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

Interventions

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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

Intervention Type DEVICE

Other Intervention Names

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CKRT

Eligibility Criteria

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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.
Minimum Eligible Age

1 Year

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ospedale Pediatrico Bambin Gesù

OTHER

Sponsor Role lead

Responsible Party

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Gabriella Bottari

Medical Doctor, Principal Investigator, Pediatric Intensivist

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Gabriella Bottari

Rome, , Italy

Site Status

Countries

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Italy

References

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Bottari G, Guzzo I, Cappoli A, Labbadia R, Perdichizzi S, Serpe C, Creteur J, Cecchetti C, Taccone FS. Impact of CytoSorb and CKRT on hemodynamics in pediatric patients with septic shock: the PedCyto study. Front Pediatr. 2023 Sep 15;11:1259384. doi: 10.3389/fped.2023.1259384. eCollection 2023.

Reference Type DERIVED
PMID: 37780052 (View on PubMed)

Other Identifiers

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AR-GB01

Identifier Type: -

Identifier Source: org_study_id