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Completed

NCT Number: NCT05658588

Hemodynamic Impact of Cytosorb and CKRT in Children With Septic Shock

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

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Key information

Conditions

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

Age range

1 year–17 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Gabriella Bottari

Rome, 00151, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Other names: CKRT

Primary outcomes

  1. Vasopressors and inotropes reduction

    Time frame: 96 hours

    Proportion of patients who achieved a significant reduction in vasopressors or inotropes dose from baseline to the end of treatment.

Secondary outcomes

  1. Changes in hemodynamic parameters

    Time frame: 96 hours

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

Other outcomes

  1. Organ dysfunction change

    Time frame: 96 hours

    changes in PELOD-2 score

  2. Biomarkers of infection change

    Time frame: 96 hours

    time-course of C-Reactive Protein, procalcitonin

  3. Perfusion indexes change

    Time frame: 96 hours

    Change lactate, PCO2 gap baseline

  4. Mortality

    Time frame: 90 days

    Mortality at 28 days, at PICU and hospital discharge

Sponsors and collaborators

Lead sponsor

Ospedale Pediatrico Bambin Gesù

Other

Registry information

Official study title

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

Acronym: PedCyto

Important dates

Study start
2019
Primary completion
2021
Study completion
2021
First posted
Dec 21, 2022
Registry last updated
Dec 21, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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