SepsisNCT00641355
Acute Phase Proteins as Early Markers in Sepsis
An observational study of Sepsis, run by University of Zurich at 1 site in Switzerland.
Trial summary
Monitoring of different serumproteins after severe trauma and during trauma-induced sepsis. Trial with surgical intervention Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Sepsis
- Type of treatment
- Surgery or procedure
- How many people
- 15 participants
- Where
- 1 siteSwitzerland
- Study dates
- Apr 2008to Sep 2012
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with severe trauma
Who may be able to join
- Patients with severe trauma (ISS score > 16), both genders, patients on ICU
Who cannot join
- Moribund patients (pH <7,1, lactate >15mmol, Basedeficit > 15mEq/L, severe heart or liver injuries, GCS never over 5 after trauma)
- Severe head injuries (AIS head >4)
- Patient with severe infectious diseases, or diseases which severely affect the immune system (diabetes, Alkohol or nicotine abuse)
- Non-german speaking patients
Trial locations and contacts
1 site in 1 country.
01 Studienregister MasterAdmins contact
About this study
Monitoring of different serumproteins after severe trauma and during trauma-induced sepsis.
- Trial with surgical intervention
- Conditions
- Sepsis
- Being tested
- No intervention
- Medical subject headings
- Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionProcedure or surgery
No intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2008 (estimated)
- Study startApr 2008
- Study completionSep 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SepsisStudies of the same condition, open and under way.
- More trials run by University of ZurichThe 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
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Investigators
- 01 Studienregister MasterAdmins, Study director, UniversitaetsSpital Zuerich
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00641355
- Sponsor's protocol ID
- StV 26-2007
- Status last verified
- Mar 2008
- First submitted
- 17 Mar 2008
- Last updated
- 24 Mar 2008
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Acute Phase Proteins as Early Markers in Sepsis
- ClinicalTrials.gov ID
- NCT00641355
- Acronym / sponsor ID
- StV 26-2007
- Conditions
- Sepsis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- Apr 2008
- Study completion
- Sep 2012 (estimated)
- First posted
- 24 Mar 2008 (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.
Monitoring of different serumproteins after severe trauma and during trauma-induced sepsis.
- Trial with surgical intervention
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with severe trauma
Key inclusion criteria (1 listed)
- Patients with severe trauma (ISS score > 16), both genders, patients on ICU
Key exclusion criteria (4 listed)
- Moribund patients (pH <7,1, lactate >15mmol, Basedeficit > 15mEq/L, severe heart or liver injuries, GCS never over 5 after trauma)
- Severe head injuries (AIS head >4)
- Patient with severe infectious diseases, or diseases which severely affect the immune system (diabetes, Alkohol or nicotine abuse)
- Non-german speaking patients
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 |
|---|---|---|
| No interventionNo intervention | Procedure or surgery | – |
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2008.
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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.
01 Studienregister MasterAdmins contact
01 Studienregister MasterAdmins study director
UniversitaetsSpital Zuerich
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, run by University of Zurich at 1 site in Switzerland.
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 4 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 24 Mar 2008. 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 Switzerland. 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 01 Studienregister MasterAdmins (+41 (0)44 255 11 11), or a site near the patient. 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 24 Mar 2008.