Severe Sepsis and Septic ShockPhase 1/2EISS-1NCT00818597
Extracorporeal Immune Support System (EISS) for the Treatment of Septic Patients
A Phase 1/2 study testing EISS in people with Severe Sepsis and Septic Shock, run by University of Rostock at 1 site in Germany.
Trial summary
The purpose of this study is to investigate the effect of an extracorporeal application of a bed-side bioreactor containing human donor granulocytes on the course and outcome of septic shock in humans. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Severe Sepsis and Septic Shock
- What is being tested?
- EISS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteGermany
- Study dates
- Dec 2003to Jun 2008
- Phase
- Phase 1/2
- 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
- sepsis with at least one organ failure (severe sepsis) or septic shock
Who cannot join
- Participation in another study within the last 30 days
- Earlier participation in this study
- Pregnancy
- Bleeding, clinically not controlled (needing more than 2 red blood cell-transfusions per day)
- Hemodynamic shock for more than 12 hours (systolic BP <90mmHg) despite adequate therapy
- HIV infection
- HCV infection, active
Trial locations and contacts
1 site in 1 country.
Germany1 site
University of Rostock, Department of Medicine, Division of Nephrology
Rostock, 18055
About this study
Official title: PhaseI/II Study of the Safety and Efficacy of the Use of Granulocyte-Concentrates Applied in Extracorporeal Circulation Devices-the EISS-1 Study
The purpose of this study is to investigate the effect of an extracorporeal application of a bed-side bioreactor containing human donor granulocytes on the course and outcome of septic shock in humans.
- Conditions
- Severe Sepsis and Septic Shock
- Being tested
- EISS
- Keywords
- septic shock, immunoparalysis, extracorporeal, granulocyte bioreactor, plasmapheresis
- 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.
EISSDevice
Two six hour-treatments with the EISS-Immune-cell bioreactor device within 72 hours post inclusion.
| Study group | Role | What they receive |
|---|---|---|
| EISS-treatment | Experimental | In this arm patients receive additional treatment with the EISS-bioreactor Receives: Device: EISS |
What is being measured
The primary outcome is the main question the study is designed to answer.
single organ functions (circulation, kidney, lung, liver)
Measured: 28day post inclusion
Secondary outcomes (1)
survival
Measured: 28day post inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2009 (estimated)
- Study startDec 2003
- Primary completionApr 2004
- Study completionJun 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Severe Sepsis and 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 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Rostock
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00818597
- Sponsor's protocol ID
- EISS-1
- Acronym
- EISS-1
- Status last verified
- Jan 2009
- First submitted
- 5 Jan 2009
- Last updated
- 7 Jan 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Mitzner SR, Freytag J, Sauer M, Kleinfeldt T, Altrichter J, Klohr S, Koball S, Stange J, Ringel B, Nebe B, Schmidt H, Podbielski A, Noeldge-Schomburg G, Schmidt R. Use of human preconditioned phagocytes for extracorporeal immune support: introduction of a concept. Ther Apher. 2001 Oct;5(5):423-32. doi: 10.1046/j.1526-0968.2001.00378.x.
PubMed 11778929Sauer M, Altrichter J, Kreutzer HJ, Logters T, Scholz M, Noldge-Schomburg G, Schmidt R, Mitzner SR. Extracorporeal cell therapy with granulocytes in a pig model of Gram-positive sepsis. Crit Care Med. 2009 Feb;37(2):606-13. doi: 10.1097/CCM.0b013e318194aa77.
PubMed 19114920Altrichter J, Sauer M, Kaftan K, Birken T, Gloger D, Gloger M, Henschel J, Hickstein H, Klar E, Koball S, Pertschy A, Noldge-Schomburg G, Vagts DA, Mitzner SR. Extracorporeal cell therapy of septic shock patients with donor granulocytes: a pilot study. Crit Care. 2011;15(2):R82. doi: 10.1186/cc10076. Epub 2011 Mar 3.
PubMed 21371308
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PhaseI/II Study of the Safety and Efficacy of the Use of Granulocyte-Concentrates Applied in Extracorporeal Circulation Devices-the EISS-1 Study
- ClinicalTrials.gov ID
- NCT00818597
- Acronym / sponsor ID
- EISS-1 / EISS-1
- Conditions
- Severe Sepsis and Septic Shock
- Keywords
- septic shock, immunoparalysis, extracorporeal, granulocyte bioreactor, plasmapheresis
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of RostockUniversity, hospital or other
- Study start
- Dec 2003
- Primary completion
- Apr 2004 (actual)
- Study completion
- Jun 2008 (actual)
- First posted
- 7 Jan 2009 (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 purpose of this study is to investigate the effect of an extracorporeal application of a bed-side bioreactor containing human donor granulocytes on the course and outcome of septic shock in humans.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| EISS-treatment | Experimental | Device: EISSIn this arm patients receive additional treatment with the EISS-bioreactor |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- sepsis with at least one organ failure (severe sepsis) or septic shock
Key exclusion criteria (7 listed)
- Participation in another study within the last 30 days
- Earlier participation in this study
- Pregnancy
- Bleeding, clinically not controlled (needing more than 2 red blood cell-transfusions per day)
- Hemodynamic shock for more than 12 hours (systolic BP <90mmHg) despite adequate therapy
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 |
|---|---|---|
| EISSTwo six hour-treatments with the EISS-Immune-cell bioreactor device within 72 hours post inclusion. | Device | EISS-treatment |
Primary outcome
single organ functions (circulation, kidney, lung, liver)
Time frame: 28day post inclusion
1 secondary outcome
survival
Time frame: 28day post inclusion
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 7 Jan 2009.
- Background: PubMed 11778929Mitzner SR, Freytag J, Sauer M, Kleinfeldt T, Altrichter J, Klohr S, Koball S, Stange J, Ringel B, Nebe B, Schmidt H, Podbielski A, Noeldge-Schomburg G, Schmidt R. Use of human preconditioned phagocytes for extracorporeal immune support: introduction of a concept. Ther Apher. 2001 Oct;5(5):423-32. doi: 10.1046/j.1526-0968.2001.00378.x.
- Background: PubMed 19114920Sauer M, Altrichter J, Kreutzer HJ, Logters T, Scholz M, Noldge-Schomburg G, Schmidt R, Mitzner SR. Extracorporeal cell therapy with granulocytes in a pig model of Gram-positive sepsis. Crit Care Med. 2009 Feb;37(2):606-13. doi: 10.1097/CCM.0b013e318194aa77.
- Derived from this study: PubMed 21371308Altrichter J, Sauer M, Kaftan K, Birken T, Gloger D, Gloger M, Henschel J, Hickstein H, Klar E, Koball S, Pertschy A, Noldge-Schomburg G, Vagts DA, Mitzner SR. Extracorporeal cell therapy of septic shock patients with donor granulocytes: a pilot study. Crit Care. 2011;15(2):R82. doi: 10.1186/cc10076. Epub 2011 Mar 3.
- Related InfoLink provided by the sponsor.
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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 Phase 1/2 study testing EISS in people with Severe Sepsis and Septic Shock, run by University of Rostock 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 1 inclusion and 7 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 7 Jan 2009. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
single organ functions (circulation, kidney, lung, liver) (time frame: 28day post inclusion). 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 NCT00818597, which also lists 3 linked publications.
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 7 Jan 2009.