Septic ShockSepsAR3NCT04259567
Improvement of Cerebrovascular Autoregulation in Patients With Septic Shock Due to Cytokine Elimination
A study testing Cytokine absorption in people with Septic Shock, run by Johannes Gutenberg University Mainz at 1 site in Germany.
Trial summary
The trial investigates the effect of cytokine elimination in patients with septic schock and acute renal failure with need for renal replacement therapy on the integrity of cerebrovascular autoregulation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Septic Shock
- What is being tested?
- Cytokine absorption
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteGermany
- Study dates
- 8 Jun 2020to 31 Jul 2022
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- septic shock
- acute renal failure with need for renal replacement therapy
Who cannot join
- pregnancy
- nursing
- impossibility to do transcranial Doppler ultrasound
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
University Medical Center of the Johannes Gutenberg-Univerity
Mainz, 55131
Patrick Schramm, MD, 00496131176755, schrammp@uni-mainz.de
Patrick Schramm, MD
About this study
Official title: Verbesserung Einer gestörten zerebrovaskulären Autoregulation Bei Patienten im Septischen Schock Durch Extrakorporale Reduktion Von Entzündungsmediatoren
The trial investigates the effect of cytokine elimination in patients with septic schock and acute renal failure with need for renal replacement therapy on the integrity of cerebrovascular autoregulation. Patients with inclusion criteria were randomly assign in either use of CytoSorb filter integrated in renal replacement therapy versus non additional filter an renal replacement therapy alone. Cerebrovascular autoregulation will be measured with transcranial Doppler ultrasound and correlation with arterial blood pressure.
- Conditions
- Septic Shock
- Being tested
- Cytokine absorption
- Keywords
- Cerebrovascular Autoregulation, Septic Shock, Cytokine
- Medical subject headings
- Shock, Septic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cytokine absorptionDevice
Use of CytoSorb absorber
| Study group | Role | What they receive |
|---|---|---|
| Filter | Active comparator | Patients with CytoSorb absorber Receives: Device: Cytokine absorption |
| Control | No intervention | Patients without CytoSorb absorber |
What is being measured
The primary outcome is the main question the study is designed to answer.
Differences in the index of cerebrovascular autoregulation (Mx) between both groups
Integrity of the cerebrovascular autoregulation will be measured using the index of cerebrovascular autoregulation Mx (moving correlation index). Outcome is the difference of the mean Mx between both groups and, therefore, the difference of integrity of the cerbrovascular autoregulation. A difference of 0.2 in Mx was set as clinically relevant.
Measured: days 1 to 4 after diagnosis of septic shock
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2020
- Study start8 Jun 2020
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Jul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Johannes Gutenberg University Mainz
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Patrick Schramm, Johannes Gutenberg University Mainz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04259567
- Sponsor's protocol ID
- V1.0_2019_06_28
- Acronym
- SepsAR3
- Status last verified
- Jun 2020
- First submitted
- 31 Jan 2020
- Last updated
- 11 Jun 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Verbesserung Einer gestörten zerebrovaskulären Autoregulation Bei Patienten im Septischen Schock Durch Extrakorporale Reduktion Von Entzündungsmediatoren
- ClinicalTrials.gov ID
- NCT04259567
- Acronym / sponsor ID
- SepsAR3 / V1.0_2019_06_28
- Conditions
- Septic Shock
- Keywords
- Cerebrovascular Autoregulation, Septic Shock, Cytokine
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Johannes Gutenberg University MainzUniversity, hospital or other
- Study start
- 8 Jun 2020 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Jul 2022 (estimated)
- First posted
- 6 Feb 2020 (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.
The trial investigates the effect of cytokine elimination in patients with septic schock and acute renal failure with need for renal replacement therapy on the integrity of cerebrovascular autoregulation. Patients with inclusion criteria were randomly assign in either use of CytoSorb filter integrated in renal replacement therapy versus non additional filter an renal replacement therapy alone. Cerebrovascular autoregulation will be measured with transcranial Doppler ultrasound and correlation with arterial blood pressure.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Filter | Active comparator | Device: Cytokine absorptionPatients with CytoSorb absorber |
| Control | No intervention | –Patients without CytoSorb absorber |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- septic shock
- acute renal failure with need for renal replacement therapy
Key exclusion criteria (3 listed)
- pregnancy
- nursing
- impossibility to do transcranial Doppler ultrasound
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 |
|---|---|---|
| Cytokine absorptionUse of CytoSorb absorber | Device | Filter |
Primary outcome
Differences in the index of cerebrovascular autoregulation (Mx) between both groups
Time frame: days 1 to 4 after diagnosis of septic shock
Integrity of the cerebrovascular autoregulation will be measured using the index of cerebrovascular autoregulation Mx (moving correlation index). Outcome is the difference of the mean Mx between both groups and, therefore, the difference of integrity of the cerbrovascular autoregulation. A difference of 0.2 in Mx was set as clinically relevant.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2020.
- Individual participant dataSharing planned: No
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Sepsis
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.
University Medical Center of the Johannes Gutenberg-Univerity
Mainz, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cytokine absorption in people with Septic Shock, run by Johannes Gutenberg University Mainz at 1 site in Germany.
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 2 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 11 Jun 2020. 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 Germany. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Differences in the index of cerebrovascular autoregulation (Mx) between both groups (time frame: days 1 to 4 after diagnosis of septic shock). 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 11 Jun 2020.