SepticemiaPhase 2/3NCT00146432
Immunoadsorption of LPS, C5a and IL-6 in Severe Sepsis and Septic Shock (ISASS-1)
A Phase 2/3 study testing Immunoadsorption of LPS, IL-6 and C5a in people with Septicemia, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial summary
The purpose of this study is to determine whether immunoadsorption of LPS, Il-6 and C5a reduces systemic hyperinflammation, improves immune function and improves organ function in patients with severe sepsis and septic shock Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Septicemia
- What is being tested?
- Immunoadsorption of LPS, IL-6 and C5a
- Type of treatment
- Surgery or procedure
- How many people
- Not given
- Where
- 1 siteGermany
- Study dates
- Start not givento not given
- Phase
- Phase 2/3
- 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 80 years
- All sexes
- Adult, Older adult
Who may be able to join
- Diagnosis of severe sepsis or septic shock (ACCP/SCCM)
- Presence of 4 SIRS criteria/indicators
- Suspected or proven infection (refer also to: 1.)
- Age 18-80
- APACHE II score > 18
- At least one acute organ dysfunction (renal/pulmonary/hemodynamics/cerebral)
Who cannot join
- Suspected or proven pregnancy
- Absolute contraindication for anticoagulation (active bleeding)
- Absolute IgA-deficiency
- History of anaphylactic reaction to egg-albumin
- Participants in other clinical trials (<12 wks. prior to study inclusion)
Trial locations and contacts
1 site in 1 country.
Germany1 site
Charite University Medicine Berlin
Berlin, State of Berlin, 13353
About this study
Official title: Prospective, Controlled Pilot Trial: Treatment of Patients in Severe Sepsis and Septic Shock With Immunoadsorption of LPS, IL-6, C5a
The purpose of this study is to determine whether immunoadsorption of LPS, Il-6 and C5a reduces systemic hyperinflammation, improves immune function and improves organ function in patients with severe sepsis and septic shock
- Conditions
- Septicemia
- Being tested
- Immunoadsorption of LPS, IL-6 and C5a
- Medical subject headings
- Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immunoadsorption of LPS, IL-6 and C5aProcedure or surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2005 (estimated)
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 SepticemiaStudies of the same condition, open and under way.
- More trials run by Charite University, Berlin, GermanyThe sponsor's other registered studies.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Collaborators
- German Research Foundation, adexter GmbH
- Investigators
- Petra Reinke, MD, PhD, Principal investigator, Charite, University Medicine Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00146432
- Sponsor's protocol ID
- ISASS-1
- Status last verified
- Aug 2009
- First submitted
- 6 Sep 2005
- Last updated
- 25 Aug 2009
- Results posted
- No
Publications
Schefold JC, von Haehling S, Corsepius M, Pohle C, Kruschke P, Zuckermann H, Volk HD, Reinke P. A novel selective extracorporeal intervention in sepsis: immunoadsorption of endotoxin, interleukin 6, and complement-activating product 5a. Shock. 2007 Oct;28(4):418-25. doi: 10.1097/shk.0b013e31804f5921.
PubMed 17558345
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Controlled Pilot Trial: Treatment of Patients in Severe Sepsis and Septic Shock With Immunoadsorption of LPS, IL-6, C5a
- ClinicalTrials.gov ID
- NCT00146432
- Acronym / sponsor ID
- ISASS-1
- Conditions
- Septicemia
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- Collaborators
- German Research Foundation, adexter GmbH
- First posted
- 7 Sep 2005 (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 determine whether immunoadsorption of LPS, Il-6 and C5a reduces systemic hyperinflammation, improves immune function and improves organ function in patients with severe sepsis and septic shock
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Factorial
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Diagnosis of severe sepsis or septic shock (ACCP/SCCM)
- Presence of 4 SIRS criteria/indicators
- Suspected or proven infection (refer also to: 1.)
- Age 18-80
- APACHE II score > 18
Key exclusion criteria (5 listed)
- Suspected or proven pregnancy
- Absolute contraindication for anticoagulation (active bleeding)
- Absolute IgA-deficiency
- History of anaphylactic reaction to egg-albumin
- Participants in other clinical trials (<12 wks. prior to study inclusion)
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 |
|---|---|---|
| Immunoadsorption of LPS, IL-6 and C5a | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
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 25 Aug 2009.
- Derived from this study: PubMed 17558345Schefold JC, von Haehling S, Corsepius M, Pohle C, Kruschke P, Zuckermann H, Volk HD, Reinke P. A novel selective extracorporeal intervention in sepsis: immunoadsorption of endotoxin, interleukin 6, and complement-activating product 5a. Shock. 2007 Oct;28(4):418-25. doi: 10.1097/shk.0b013e31804f5921.
- 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.
Petra Reinke, MD, PhD principal investigator
Charite, University Medicine Berlin, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Immunoadsorption of LPS, IL-6 and C5a in people with Septicemia, run by Charite University, Berlin, Germany 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 6 inclusion and 5 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 25 Aug 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00146432, 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 25 Aug 2009.