SepsisNCT04749238
Effect of Extracorporeal Adsorption of Plasma Neutrophil Extracellular Traps (NET) in Sepsis
A study testing NucleoCapture device in people with Sepsis and Sepsis-associated AKI, run by Santersus AG at 1 site in Russia.
Trial summary
This open non-randomized controlled single center study investigates to what extent the removal of circulating Neutrophil Extracellular Traps (NETs) from blood by NucleoCapture device has a positive effect on the treatment of patients with sepsis and sepsis-associated AKI (SA-AKI). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Sepsis, Sepsis-associated AKI
- What is being tested?
- NucleoCapture device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteRussia
- Study dates
- 26 Jan 2021to 24 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female ≥ 18 and ≤ 75 years of age.
- Meet the clinical criteria of sepsis according to the Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3))
- Written informed consent
Who cannot join
- A terminal state
- Active bleeding or uncontrolled acute massive bleeding
Trial locations and contacts
1 site in 1 country.
Russia1 site
North-Western Regional Scientific and Clinical Center named after L.G. Sokolov
Saint Petersburg
About this study
Official title: Safety and Efficacy Assessment of NucleoCapture Selective DNA Adsorber in Humans
This open non-randomized controlled single center study investigates to what extent the removal of circulating Neutrophil Extracellular Traps (NETs) from blood by NucleoCapture device has a positive effect on the treatment of patients with sepsis and sepsis-associated AKI (SA-AKI).
Read the detailed description
The term "sepsis" refers to a clinical syndrome in which a dysregulation of the host's inflammatory reaction to infection leads to a life-threatening of organ dysfunctions. Sepsis and septic shock are major causes of death in intensive care units worldwide. Sepsis remains the most important cause of AKI in the intensive care unit (ICU) with 15%-20% of patients with sepsis-associated AKI (SA-AKI) prescribed RRT . In addition to association with short term mortality, AKI is also linked to the later development of CKD, ESRD, and long-term increased risk of death
NETosis is a unique form of neutrophil cell death that is characterized by the release of neutrophil extracellular traps (NETs) composed of DNA web-like structures decorated with highly cytotoxic protein components. Release of NETs leads to bystander tissue damage (including the kidneys) and drives a fatal course of disease in sepsis patients.
The plasmapheresis is a medical procedure, where pathogenic components are being removed from the blood by adsorbers outside the body in an extracorporeal circulation. For removal of the pathogenic substances the plasma is separated from the blood to pass the adsorber. The purified plasma is merged with the solid blood components thereafter and returned to the patient. The NucleoCapture device provide highly selective removal of neutrophil extracellular traps from human blood during plasmapheresis procedure.
- Conditions
- Sepsis, Sepsis-associated AKI
- Being tested
- NucleoCapture device
- Medical subject headings
- Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NucleoCapture deviceDevice
Also called NucleoCapture selective DNA adsorber
Device: 100 ml NucleoCapture selective DNA adsorber. Treatment with NucleoCapture in one arm
| Study group | Role | What they receive |
|---|---|---|
| Treatment with NucleoCapture device | Experimental | Device: 100 ml NucleoCapture selective DNA adsorber. Treatment with NucleoCapture in one arm. Receives: Device: NucleoCapture device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of acute kidney injury (AKI)
Incidence of acute kidney injury (AKI) in accordance with Kidney Disease Improving Global Outcomes (KDIGO) definitions for AKI
Measured: from [start of treatment] through 28 days after
Severity of acute kidney injury (AKI)
Severity of acute kidney injury (AKI) in accordance with KDIGO definitions for AKI
Measured: from [start of treatment] through 28 days after
Rate of AKI transition to the more severe stage (for patients with AKI at baseline).
Rate of worsening of acute kidney injury (AKI) in accordance with KDIGO AKI classification (Changing stages from 1 to 2, from 2 to 3).
Measured: from [start of treatment] through 28 days after
Serum creatinine change over time
Change of creatinine in serum over time for each patient and in average in group
Measured: from [start of treatment] through 28 days after
Serum urea change over time
Change of urea in serum over time for each patient and in average in group
Measured: from [start of treatment] through 28 days after
Urine output change
Change of urine output over time for each patient and in average in group
Measured: from [start of treatment] through 28 days after
Secondary outcomes (3)
All-cause mortality
Mortality for any reasons for each patient and in average in group
Measured: from [start of treatment] through 28 days after
SOFA scores change
Change in SOFA scores over time for each patient and in average in group
Measured: from [start of treatment] through 28 days after
qSOFA scores change
Change in qSOFA scores over time for each patient and in average in group
Measured: from [start of treatment] through 28 days after
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2021
- Study start26 Jan 2021
- Primary completion24 Oct 2021
- Study completion24 Oct 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SepsisStudies 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
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Santersus AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04749238
- Sponsor's protocol ID
- Nucleo 514/2020
- Status last verified
- Dec 2022
- First submitted
- 28 Jan 2021
- Last updated
- 6 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Efficacy Assessment of NucleoCapture Selective DNA Adsorber in Humans
- ClinicalTrials.gov ID
- NCT04749238
- Acronym / sponsor ID
- Nucleo 514/2020
- Conditions
- Sepsis, Sepsis-associated AKI
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Santersus AGIndustry (pharma, biotech, devices)
- Study start
- 26 Jan 2021 (actual)
- Primary completion
- 24 Oct 2021 (actual)
- Study completion
- 24 Oct 2021 (actual)
- First posted
- 11 Feb 2021 (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.
This open non-randomized controlled single center study investigates to what extent the removal of circulating Neutrophil Extracellular Traps (NETs) from blood by NucleoCapture device has a positive effect on the treatment of patients with sepsis and sepsis-associated AKI (SA-AKI).
Detailed description
The term "sepsis" refers to a clinical syndrome in which a dysregulation of the host's inflammatory reaction to infection leads to a life-threatening of organ dysfunctions. Sepsis and septic shock are major causes of death in intensive care units worldwide. Sepsis remains the most important cause of AKI in the intensive care unit (ICU) with 15%-20% of patients with sepsis-associated AKI (SA-AKI) prescribed RRT . In addition to association with short term mortality, AKI is also linked to the later development of CKD, ESRD, and long-term increased risk of death
NETosis is a unique form of neutrophil cell death that is characterized by the release of neutrophil extracellular traps (NETs) composed of DNA web-like structures decorated with highly cytotoxic protein components. Release of NETs leads to bystander tissue damage (including the kidneys) and drives a fatal course of disease in sepsis patients.
The plasmapheresis is a medical procedure, where pathogenic components are being removed from the blood by adsorbers outside the body in an extracorporeal circulation. For removal of the pathogenic substances the plasma is separated from the blood to pass the adsorber. The purified plasma is merged with the solid blood components thereafter and returned to the patient. The NucleoCapture device provide highly selective removal of neutrophil extracellular traps from human blood during plasmapheresis procedure.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment with NucleoCapture device | Experimental | Device: NucleoCapture deviceDevice: 100 ml NucleoCapture selective DNA adsorber. Treatment with NucleoCapture in one arm. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Male or female ≥ 18 and ≤ 75 years of age.
- Meet the clinical criteria of sepsis according to the Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3))
- Written informed consent
Key exclusion criteria (2 listed)
- A terminal state
- Active bleeding or uncontrolled acute massive bleeding
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 |
|---|---|---|
| NucleoCapture deviceAlso: NucleoCapture selective DNA adsorberDevice: 100 ml NucleoCapture selective DNA adsorber. Treatment with NucleoCapture in one arm | Device | Treatment with NucleoCapture device |
Primary outcome
Incidence of acute kidney injury (AKI)
Time frame: from [start of treatment] through 28 days after
Incidence of acute kidney injury (AKI) in accordance with Kidney Disease Improving Global Outcomes (KDIGO) definitions for AKI
Severity of acute kidney injury (AKI)
Time frame: from [start of treatment] through 28 days after
Severity of acute kidney injury (AKI) in accordance with KDIGO definitions for AKI
Rate of AKI transition to the more severe stage (for patients with AKI at baseline).
Time frame: from [start of treatment] through 28 days after
Rate of worsening of acute kidney injury (AKI) in accordance with KDIGO AKI classification (Changing stages from 1 to 2, from 2 to 3).
Serum creatinine change over time
Time frame: from [start of treatment] through 28 days after
Change of creatinine in serum over time for each patient and in average in group
Serum urea change over time
Time frame: from [start of treatment] through 28 days after
Change of urea in serum over time for each patient and in average in group
Urine output change
Time frame: from [start of treatment] through 28 days after
Change of urine output over time for each patient and in average in group
3 secondary outcomes
All-cause mortality
Time frame: from [start of treatment] through 28 days after
SOFA scores change
Time frame: from [start of treatment] through 28 days after
qSOFA scores change
Time frame: from [start of treatment] through 28 days after
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 6 Dec 2022.
- Individual participant dataSharing planned: Undecided
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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 NucleoCapture device in people with Sepsis and Sepsis-associated AKI, run by Santersus AG at 1 site in Russia.
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 6 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 Russia. 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?
Incidence of acute kidney injury (AKI) (time frame: from [start of treatment] through 28 days after). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Dec 2022.