Septic ShockPedCytoNCT05658588
Hemodynamic Impact of Cytosorb and CKRT in Children With Septic Shock
A study testing Cytosorb in people with Septic Shock, run by Ospedale Pediatrico Bambin Gesù at 1 site in Italy.
Trial summary
Impact of the hemoadsorption with Cytosorb on hemodynamic in pediatric patients with septic shock: a prospectic pediatric pilot study Read more about this study
- Who is it for?
- Ages 1 year to 17 years
- Conditions the study is for
- Septic Shock
- What is being tested?
- Cytosorb
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 17 participants
- Where
- 1 siteItaly
- Study dates
- 1 Sep 2019to 1 Oct 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 year to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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%
Who cannot join
- Refused consensus by parents
- Concomitant use of other extracorporeal blood purification techniques.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Cytosorb and CKRT on Hemodynamics in Pediatric Patients With Septic Shock: the PedCyto Study
Impact of the hemoadsorption with Cytosorb on hemodynamic in pediatric patients with septic shock: a prospectic pediatric pilot study
Read the 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.
- Conditions
- Septic Shock
- Being tested
- Cytosorb
- Keywords
- Pediatric Septic Shock, Blood Purification, AKI, Pediatric Critical Care, Hemoperfusion, CKRT
- Medical subject headings
- Shock, Septic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CytosorbDevice
Also called CKRT
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
| Study group | Role | What they receive |
|---|---|---|
| Hemoperfusion and CKRT in pediatric septic shock | Experimental | Hemoperfusion with Cytosorb in combination with CKRT Receives: Device: Cytosorb |
What is being measured
The primary outcome is the main question the study is designed to answer.
Vasopressors and inotropes reduction
Proportion of patients who achieved a significant reduction in vasopressors or inotropes dose from baseline to the end of treatment.
Measured: 96 hours
Secondary outcomes (1)
Changes in hemodynamic parameters
changes in CI, SVRI, systolic pressure - Psys, diastolic pressure - Pdia, and mean pressure
Measured: 96 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2022
- Study start1 Sep 2019
- Primary completion1 Oct 2021
- Study completion1 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Septic ShockStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- a two-stage plan by Simon
- Masking
- None (open label)
- Enrolment
- 17 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ospedale Pediatrico Bambin Gesù
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gabriella Bottari, Ospedale Pediatrico Bambin Gesù
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05658588
- Sponsor's protocol ID
- AR-GB01
- Acronym
- PedCyto
- Status last verified
- Dec 2022
- First submitted
- 4 Dec 2022
- Last updated
- 21 Dec 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 37780052
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Cytosorb and CKRT on Hemodynamics in Pediatric Patients With Septic Shock: the PedCyto Study
- ClinicalTrials.gov ID
- NCT05658588
- Acronym / sponsor ID
- PedCyto / AR-GB01
- Conditions
- Septic Shock
- Keywords
- Pediatric Septic Shock, Blood Purification, AKI, Pediatric Critical Care, Hemoperfusion, CKRT
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 17 participants (actual)
- Lead sponsor
- Ospedale Pediatrico Bambin GesùUniversity, hospital or other
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 1 Oct 2021 (actual)
- Study completion
- 1 Oct 2021 (actual)
- First posted
- 21 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- a two-stage plan by Simon
| Arm | Type | Receives |
|---|---|---|
| Hemoperfusion and CKRT in pediatric septic shock | Experimental | Device: CytosorbHemoperfusion with Cytosorb in combination with CKRT |
Who may qualify
- Ages
- 1 year to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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%
Key exclusion criteria (2 listed)
- Refused consensus by parents
- Concomitant use of other extracorporeal blood purification techniques.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CytosorbAlso: CKRTCytosorb 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 | Device | Hemoperfusion and CKRT in pediatric septic shock |
Primary outcome
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.
1 secondary outcome
Changes in hemodynamic parameters
Time frame: 96 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2022.
- Derived from this study: PubMed 37780052Bottari 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cytosorb in people with Septic Shock, run by Ospedale Pediatrico Bambin Gesù at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Vasopressors and inotropes reduction (time frame: 96 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05658588, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Dec 2022.