InflammationTusepNCT02692118
Inflammatory Mediators in Early Sepsis
An observational study of Inflammation, run by University Hospital Tuebingen at 1 site in Germany.
Trial summary
Sepsis is still a challenge for clinicians since the detailed pathomechanism are still unknown and until now early markers for sepsis are not defined yet. Immunological pathways and new mediators defined in animal models are not yet investigated in patients with sepsis. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Inflammation
- How many people
- 60 participants
- Where
- 1 siteGermany
- Study dates
- Dec 2016to Sep 2022
- 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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Intensive Care patients with septic shock
Who may be able to join
- Septic Shock
Who cannot join
- Age < 18 > 85
- no consent of caregiver
- Trauma patients
- Burn patients
- Immunosuppression
- Pregnancy
- HIV- hepatitis infection
Trial locations and contacts
1 site in 1 country.
Germany1 site, 1 recruiting
- Recruiting
University Hospital Tuebingen
Tübingen, 72076
Peter Rosenberger, MD
Helene A Haeberle, MD
About this study
Official title: Inflammatory Mediators in Sepsis as Indicator for Infection vs Inflammation
Sepsis is still a challenge for clinicians since the detailed pathomechanism are still unknown and until now early markers for sepsis are not defined yet. Immunological pathways and new mediators defined in animal models are not yet investigated in patients with sepsis. Therefore the investigators will measure new mediators in patients with septic shock.
Read the detailed description
Semaphorins 1 to 7 will be determined in Blood of patients with early septic shock. Concentration will be compared with blood concentration of postoperative patients suffering systemic inflammatory response syndrome (SIRS).
- Conditions
- Inflammation
- Medical subject headings
- Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| sepsis | Patients with septic shock admitted to ICU |
What is being measured
The primary outcome is the main question the study is designed to answer.
Semaphorin 1 to 7 in plasma of septic patients
Concentration of Semaphorin in plasma of 60 sepsis patients [pg/ml].
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2016 (estimated)
- Study startDec 2016
- Primary completionJun 2022 (estimated)
- Study completionSep 2022 (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 InflammationStudies of the same condition, open and under way.
- More trials run by University Hospital TuebingenThe 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Tuebingen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Peter Rosenberger, MD, Principal investigator, University Hospital Tuebingen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02692118
- Sponsor's protocol ID
- AnaTubingen
- Acronym
- Tusep
- Status last verified
- Jun 2021
- First submitted
- 22 Feb 2016
- Last updated
- 7 Jun 2021
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Granja T, Kohler D, Tang L, Burkard P, Eggstein C, Hemmen K, Heinze KG, Heck-Swain KL, Koeppen M, Gunther S, Blaha M, Magunia H, Bamberg M, Konrad F, Ngamsri KC, Fuhr A, Keller M, Bernard AM, Haeberle HA, Bakchoul T, Zarbock A, Nieswandt B, Rosenberger P. Semaphorin 7A coordinates neutrophil response during pulmonary inflammation and sepsis. Blood Adv. 2024 Jun 11;8(11):2660-2674. doi: 10.1182/bloodadvances.2023011778.
PubMed 38489236
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inflammatory Mediators in Sepsis as Indicator for Infection vs Inflammation
- ClinicalTrials.gov ID
- NCT02692118
- Acronym / sponsor ID
- Tusep / AnaTubingen
- Conditions
- Inflammation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University Hospital TuebingenUniversity, hospital or other
- Study start
- Dec 2016 (actual)
- Primary completion
- Jun 2022 (estimated)
- Study completion
- Sep 2022 (estimated)
- First posted
- 25 Feb 2016 (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.
Sepsis is still a challenge for clinicians since the detailed pathomechanism are still unknown and until now early markers for sepsis are not defined yet. Immunological pathways and new mediators defined in animal models are not yet investigated in patients with sepsis. Therefore the investigators will measure new mediators in patients with septic shock.
Detailed description
Semaphorins 1 to 7 will be determined in Blood of patients with early septic shock. Concentration will be compared with blood concentration of postoperative patients suffering systemic inflammatory response syndrome (SIRS).
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| sepsis | – | –Patients with septic shock admitted to ICU |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Intensive Care patients with septic shock
Key inclusion criteria (1 listed)
- Septic Shock
Key exclusion criteria (7 listed)
- Age < 18 > 85
- no consent of caregiver
- Trauma patients
- Burn patients
- Immunosuppression
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
Semaphorin 1 to 7 in plasma of septic patients
Time frame: 12 months
Concentration of Semaphorin in plasma of 60 sepsis patients [pg/ml].
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2021.
- Derived from this study: PubMed 38489236Granja T, Kohler D, Tang L, Burkard P, Eggstein C, Hemmen K, Heinze KG, Heck-Swain KL, Koeppen M, Gunther S, Blaha M, Magunia H, Bamberg M, Konrad F, Ngamsri KC, Fuhr A, Keller M, Bernard AM, Haeberle HA, Bakchoul T, Zarbock A, Nieswandt B, Rosenberger P. Semaphorin 7A coordinates neutrophil response during pulmonary inflammation and sepsis. Blood Adv. 2024 Jun 11;8(11):2660-2674. doi: 10.1182/bloodadvances.2023011778.
- Individual participant dataSharing planned: Undecided
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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.
Peter Rosenberger, MD principal investigator
University Hospital Tuebingen
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 Inflammation, run by University Hospital Tuebingen 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: status not confirmed, as of the sponsor's last update on 7 Jun 2021. 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?
Contact Peter Rosenberger, MD (+49(0)7071298 ext. 6622, peter.rosenberger@med.uni-tuebingen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Semaphorin 1 to 7 in plasma of septic patients (time frame: 12 months). 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 NCT02692118, 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 7 Jun 2021.