An interventional study of Cytosorb in Septic Shock, sponsored by Ospedale Pediatrico Bambin Gesù. Completed at 1 site in Italy. Open to participants aged 1 Year to 17 Years. Per ClinicalTrials.gov, last updated 2022-12-21.
Sponsored by Ospedale Pediatrico Bambin Gesù · Not applicable, Interventional, and Treatment
Impact of the hemoadsorption with Cytosorb on hemodynamic in pediatric patients with septic shock: a prospectic pediatric pilot 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.
862 studies on the registry are indexed under Shock, Septic; 207 are open to participants now.
This study's enrollment of 17 is below the median of 80 across 530 interventional studies indexed under Shock, Septic.
Browse Shock, Septic studies →This is the only study on the registry with Ospedale Pediatrico Bambin Gesù as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Hemoperfusion with Cytosorb in combination with CKRT
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
Also known as: CKRT
Vasopressors and inotropes reduction
Proportion of patients who achieved a significant reduction in vasopressors or inotropes dose from baseline to the end of treatment.
Time frame: 96 hours
Changes in hemodynamic parameters
changes in CI, SVRI, systolic pressure - Psys, diastolic pressure - Pdia, and mean pressure
Time frame: 96 hours
Organ dysfunction change
changes in PELOD-2 score
Time frame: 96 hours
Biomarkers of infection change
time-course of C-Reactive Protein, procalcitonin
Time frame: 96 hours
Perfusion indexes change
Change lactate, PCO2 gap baseline
Time frame: 96 hours
Mortality
Mortality at 28 days, at PICU and hospital discharge
Time frame: 90 days
This study is completed, as verified in Dec 2022. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.