Sepsis, Septic ShockNCT00525369
IL 6 Measurement Using a New Densitometric Bedside (POC) Test
An observational study of Sepsis, Septic Shock, run by Charite University, Berlin, Germany at 1 site in Germany.
Trial summary
In a equivalence analysis, we determined whether IL-6 can be assessed using a new densitometric point-of-care (POC) assay (turn-around -time: 20 minutes).IL-6 measurements were compared to test results obtained with conventional ELISA analysis Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Sepsis, Septic Shock
- How many people
- Not given
- Where
- 1 siteGermany
- Study dates
- Start not givento not given
- 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 to 90 years
- All sexes
- Adult, Older adult
Who may be able to join
- Age 18-90
- Written informed consent
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Germany1 site
Charite University Medicine Berlin
Berlin, State of Berlin, 13353
About this study
In a equivalence analysis, we determined whether IL-6 can be assessed using a new densitometric point-of-care (POC) assay (turn-around -time: 20 minutes).IL-6 measurements were compared to test results obtained with conventional ELISA analysis
Read the detailed description
In an equivalence analysis, we determined whether IL-6 can be assessed using a new densitometric point-of-care (POC) assay (turn-around -time: 20 minutes) that allows IL-6 measurements at the bedside. We then compared the respective test results to those obtained with conventional ELISA analysis
- Conditions
- Sepsis, Septic Shock
- Medical subject headings
- Sepsis, Shock, Septic
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2007 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sepsis, Septic ShockStudies 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
- Observational
- Observational model
- Defined population
- Time perspective
- Other
Sponsor and investigators
- Lead sponsor
- Charite University, Berlin, Germany
- Sponsor type
- University, hospital or other
- Investigators
- Hans-Georg Schlosser, MD, Principal investigator, Charite University, Berlin, GermanyJoerg C Schefold, MD, Principal investigator, Charite University, Berlin, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00525369
- Sponsor's protocol ID
- STU-IL-6-1
- Status last verified
- Sep 2007
- First submitted
- 4 Sep 2007
- Last updated
- 5 Sep 2007
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- IL 6 Measurement Using a New Densitometric Bedside (POC) Test
- ClinicalTrials.gov ID
- NCT00525369
- Acronym / sponsor ID
- STU-IL-6-1
- Conditions
- Sepsis, Septic Shock
- Study type
- Observational
- Recruitment status
- Completed
- Lead sponsor
- Charite University, Berlin, GermanyUniversity, hospital or other
- First posted
- 5 Sep 2007 (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.
In a equivalence analysis, we determined whether IL-6 can be assessed using a new densitometric point-of-care (POC) assay (turn-around -time: 20 minutes).IL-6 measurements were compared to test results obtained with conventional ELISA analysis
Detailed description
In an equivalence analysis, we determined whether IL-6 can be assessed using a new densitometric point-of-care (POC) assay (turn-around -time: 20 minutes) that allows IL-6 measurements at the bedside. We then compared the respective test results to those obtained with conventional ELISA analysis
Study design
- Observational model
- Defined population
- Time perspective
- Other
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age 18-90
- Written informed consent
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
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 5 Sep 2007.
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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.
Hans-Georg Schlosser, MD principal investigator
Charite University, Berlin, Germany
Joerg C Schefold, MD principal investigator
Charite University, Berlin, Germany
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, Septic Shock, 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 2 inclusion and 0 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 5 Sep 2007. 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?
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?
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 5 Sep 2007.