SepsisNCT02288975
Adsorbtion of Cytokines Early in Septic Shock: the ACESS Study
An observational study of Sepsis and Septic Shock, run by Zsolt Molnár, MD, PhD, DEAA at 1 site in Hungary.
Trial summary
The aim of the study is to investigate the effect of CytoSorb® treatment within the first 48 hours of septic shock on organ dysfunction, microcirculation and on the cytokine storm as monitored by leukocyte activation and inflammatory mediators. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sepsis, Septic Shock
- What is being tested?
- CytoSorb 300ml device (3804606CE01)
- Type of treatment
- Medical device
- How many people
- 20 participants
- Where
- 1 siteHungary
- Study dates
- Oct 2014to Dec 2017
- Phase
- Observational
- 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
Study population: ICU patients with septic shock of medical origin
Who may be able to join
- Signs of hypoperfusion: serum lactate >2 mmol/L, low central venous oxygen saturation (ScvO2) (<70%) or high ScvO2 (>85%), metabolic acidosis, oligo-anuria, high venous-to-arterial CO2-gap (dCO2 >6 mm Hg)
- Hemodynamic support with vasopressors
- Procalcitonin level ≥ 3 ng/ml
- Invasive hemodynamic monitoring
- Written informed content
Who cannot join
- Patients under 18 years
- Pregnancy (bHCG test positivity)
- Surgical intervention in context with the septic insult
- New York Heart Association IV heart failure
- Acute coronary syndrome
- Need for acute or chronic hemodialysis
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- Acute haematological malignancies
- Cardiogenic shock
- Post cardiopulmonary resuscitation care
- Immunosuppression, systemic steroid therapy (>10mg prednisolon/day)
- Human immunodeficiency virus infection (HIV) and active AIDS
- Patients with donated organs
- Thrombocytopenia (<20.000/ml)
- More than 10%-of body surface area with third degree burn
Trial locations and contacts
1 site in 1 country.
Hungary1 site
Department of Anaesthesiology and Intensive Therapy
Szeged, Csongrád megye, H-6725
About this study
Official title: The Effect of Early Cytokine Absorption on the Systemic Inflammatory Response Syndrome and Organ Dysfunction in the First 48 Hours of Septic Shock
The aim of the study is to investigate the effect of CytoSorb® treatment within the first 48 hours of septic shock on organ dysfunction, microcirculation and on the cytokine storm as monitored by leukocyte activation and inflammatory mediators.
- Conditions
- Sepsis, Septic Shock
- Being tested
- CytoSorb 300ml device (3804606CE01)
- Keywords
- hemoadsorption, extracorporeal blood purification, CytoSorb, hemofiltration, SIRS, sepsis, septic shock, membranes, ICU, dialysis, adsorption
- Medical subject headings
- Sepsis, Shock, Septic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CytoSorb 300ml device (3804606CE01)Device
| Study group | Role | What they receive |
|---|---|---|
| CytoSorb | Patients with septic shock will get routine ICU care supported by CytoSorb® treatment. Receives: Device: CytoSorb 300ml device (3804606CE01) | |
| Control | Patients with septic shock will get routine ICU care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cytokine response
Cytokine response: procalcitonin, C-reactive protein, interleukin-1, interleukin-1ra, interleukin-6, interleukin-8, interleukin-10, Tumor Necrosis Factor- α
Measured: First 48 hours of septic shock
Organ dysfunctions
Organ dysfunctions: SOFA-scores, neurologic function (Glasgow coma scale), hemodynamic function (PiCCO parameters, ScvO2, lactate, dCO2), pulmonary function (gas exchange, pulmonary mechanics, Acute Respiratory Distress Syndrome classification (BERLIN)), renal function (KDIGO-, RIFLE-scores), gastrointestinal function (liver, GIT function, hematology (hemostasis, qualitative blood count)
Measured: First 48 hours of septic shock
Secondary outcomes (2)
Leukocyte function
Leukocyte function: heterogeneity of leukocyte cell population in the bloodstream, T-cell activation and apoptosis, leukocyte inflammatory markers expression
Measured: First 48 hours of septic shock
Microcirculation
Microcirculation: orthogonal polarization spectroscopy (OPS), gastric tonometry
Measured: First 48 hours 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 posted13 Nov 2014 (estimated)
- Study startOct 2014
- Primary completionDec 2017
- Study completionDec 2017
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 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zsolt Molnár, MD, PhD, DEAA
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Zsolt Molnár, MD, PhD, DEAA, Szeged University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02288975
- Sponsor's protocol ID
- CytoSorb-2014
- Status last verified
- Mar 2018
- First submitted
- 5 Nov 2014
- Last updated
- 27 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
Hawchar F, Laszlo I, Oveges N, Trasy D, Ondrik Z, Molnar Z. Extracorporeal cytokine adsorption in septic shock: A proof of concept randomized, controlled pilot study. J Crit Care. 2019 Feb;49:172-178. doi: 10.1016/j.jcrc.2018.11.003. Epub 2018 Nov 10.
PubMed 30448517
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Early Cytokine Absorption on the Systemic Inflammatory Response Syndrome and Organ Dysfunction in the First 48 Hours of Septic Shock
- ClinicalTrials.gov ID
- NCT02288975
- Acronym / sponsor ID
- CytoSorb-2014
- Conditions
- Sepsis, Septic Shock
- Keywords
- hemoadsorption, extracorporeal blood purification, CytoSorb, hemofiltration, SIRS, sepsis, septic shock, membranes
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Zsolt Molnár, MD, PhD, DEAAUniversity, hospital or other
- Study start
- Oct 2014
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 13 Nov 2014 (estimated)
- 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 aim of the study is to investigate the effect of CytoSorb® treatment within the first 48 hours of septic shock on organ dysfunction, microcirculation and on the cytokine storm as monitored by leukocyte activation and inflammatory mediators.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CytoSorb | – | Device: CytoSorb 300ml device (3804606CE01)Patients with septic shock will get routine ICU care supported by CytoSorb® treatment. |
| Control | – | –Patients with septic shock will get routine ICU care. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- ICU patients with septic shock of medical origin
Key inclusion criteria (5 listed)
- Signs of hypoperfusion: serum lactate >2 mmol/L, low central venous oxygen saturation (ScvO2) (<70%) or high ScvO2 (>85%), metabolic acidosis, oligo-anuria, high venous-to-arterial CO2-gap (dCO2 >6 mm Hg)
- Hemodynamic support with vasopressors
- Procalcitonin level ≥ 3 ng/ml
- Invasive hemodynamic monitoring
- Written informed content
Key exclusion criteria (14 listed)
- Patients under 18 years
- Pregnancy (bHCG test positivity)
- Surgical intervention in context with the septic insult
- New York Heart Association IV heart failure
- Acute coronary syndrome
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 |
|---|---|---|
| CytoSorb 300ml device (3804606CE01) | Device | CytoSorb |
Primary outcome
Cytokine response
Time frame: First 48 hours of septic shock
Cytokine response: procalcitonin, C-reactive protein, interleukin-1, interleukin-1ra, interleukin-6, interleukin-8, interleukin-10, Tumor Necrosis Factor- α
Organ dysfunctions
Time frame: First 48 hours of septic shock
Organ dysfunctions: SOFA-scores, neurologic function (Glasgow coma scale), hemodynamic function (PiCCO parameters, ScvO2, lactate, dCO2), pulmonary function (gas exchange, pulmonary mechanics, Acute Respiratory Distress Syndrome classification (BERLIN)), renal function (KDIGO-, RIFLE-scores), gastrointestinal function (liver, GIT function, hematology (hemostasis, qualitative blood count)
2 secondary outcomes
Leukocyte function
Time frame: First 48 hours of septic shock
Microcirculation
Time frame: First 48 hours of septic shock
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 27 Mar 2018.
- Derived from this study: PubMed 30448517Hawchar F, Laszlo I, Oveges N, Trasy D, Ondrik Z, Molnar Z. Extracorporeal cytokine adsorption in septic shock: A proof of concept randomized, controlled pilot study. J Crit Care. 2019 Feb;49:172-178. doi: 10.1016/j.jcrc.2018.11.003. Epub 2018 Nov 10.
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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?
An observational study of Sepsis and Septic Shock, run by Zsolt Molnár, MD, PhD, DEAA at 1 site in Hungary.
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 5 inclusion and 14 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 27 Mar 2018. 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 Hungary. 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?
Cytokine response (time frame: First 48 hours of septic shock). The study lists 2 primary outcomes in all. 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 NCT02288975, 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 27 Mar 2018.