Hemodynamic Impact of Cytosorb and CKRT in Children With Septic Shock

NCT05658588 | Completed DMC

• 1 other identifier: AR-GB01
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Septic Shock

Keywords

Pediatric Septic Shock; Blood Purification; AKI; Pediatric Critical Care; Hemoperfusion; CKRT

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Changes in hemodynamic parameters

  96 hours

Other Outcomes (4)

• Organ dysfunction change

  96 hours

• Biomarkers of infection change

  96 hours

• Perfusion indexes change

  96 hours

Study Arms (1)

Hemoperfusion and CKRT in pediatric septic shock

EXPERIMENTAL

Hemoperfusion with Cytosorb in combination with CKRT

Device: Cytosorb

Interventions

Cytosorb 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

Also known as: CKRT

Hemoperfusion and CKRT in pediatric septic shock

Eligibility Criteria

• Age: 1 Year - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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%

You may not qualify if:

• Refused consensus by parents
• Concomitant use of other extracorporeal blood purification techniques.

Sponsors & Collaborators

• Ospedale Pediatrico Bambin Gesù: lead

Study Sites (1)

Gabriella Bottari

Rome, 00151, Italy

Location

Related Publications (1)

• 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.

  PMID: 37780052 DERIVED

MeSH Terms

Conditions

Shock, Septic

Condition Hierarchy (Ancestors)

Sepsis; Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Shock

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor, Principal Investigator, Pediatric Intensivist

Model Details: a two-stage plan by Simon

Study Record Dates

• First Submitted: December 4, 2022
• First Posted: December 21, 2022
• Study Start: September 1, 2019
• Primary Completion: October 1, 2021
• Study Completion: October 1, 2021
• Last Updated: December 21, 2022

Record last verified: 2022-12

Locations

IT (1)