Septic ShockADSeSNCT01632059
Examination of ADMA Serum Level and DDAH II
An observational study of Septic Shock and Sepsis, run by Universitätsklinikum Hamburg-Eppendorf at 1 site in Germany.
Trial summary
Examination of ADMA (Asymmetric-Dimethylarginine)-serum level and DDAH II (Dimethylarginine Dimethylaminohydrolase)- Polymorphism in patients with severe Sepsis and septic shock as prognostic value. This study looks into ADMA as a good prognostic factor for sepsis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Septic Shock, Sepsis
- How many people
- 120 participants
- Where
- 1 siteGermany
- Study dates
- Feb 2012to Apr 2017
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients > 18 y/o with sepsis and/or septical shock
Who may be able to join
- >18 y/o
- sepsis
- septical shock
Who cannot join
- primary cardiogenic shock
- pregnancy
- breastfeeding
- non compliance
- moribund status
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Examination of ADMA (Asymmetric-dimethylarginine)-Serum Level and DDAH II (Dimethylarginine Dimethylaminohydrolase)- Polymorphism in Patients With Severe Sepsis and Septic Shock as Prognostic Value
Examination of ADMA (Asymmetric-Dimethylarginine)-serum level and DDAH II (Dimethylarginine Dimethylaminohydrolase)- Polymorphism in patients with severe Sepsis and septic shock as prognostic value.
This study looks into ADMA as a good prognostic factor for sepsis. Further more the dependency of the ADMA level to the DDAH II polymorphisms is reviewed this study.
Read the detailed description
Secondary targets are the mortality (28 days ICU), the length of hospitalisation in ICU and peripheral station, the severity of the illness (SAPS II score), the SOFA-score values in the progress and the procalcitonin values in the progress
- Conditions
- Septic Shock, Sepsis
- Keywords
- ADMA, DDAH II, SAPS, SOFA, Sepsis, Procalcitonin, ICU, mortality, length of stay
- Medical subject headings
- Shock, Septic, Sepsis
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 |
|---|---|---|
| septical patients | inclusion criteria are severe sepsis and septical shock and must be > 18 y/o |
What is being measured
The primary outcome is the main question the study is designed to answer.
ADMA serum levels
measuring of ADMA serum levels on day 1, 3, 7
Measured: 7 days
Secondary outcomes (4)
28 day mortality
Measured: 28 day
hospitalisation (ICU and peripheral)
Measured: 28 days
severity of illness
Measured: 28 days
DDAH Ii polymorphism
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2012 (estimated)
- Study startFeb 2012
- Primary completionMar 2013
- Study completionApr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Septic ShockStudies of the same condition, open and under way.
- More trials run by Universitätsklinikum Hamburg-EppendorfThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitätsklinikum Hamburg-Eppendorf
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stefan Kluge, Priv.-Doz., Study director, Director of critical care center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01632059
- Sponsor's protocol ID
- ADSeS (PV3927)
- Acronym
- ADSeS
- Status last verified
- Aug 2017
- First submitted
- 13 Mar 2012
- Last updated
- 3 Aug 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Examination of ADMA (Asymmetric-dimethylarginine)-Serum Level and DDAH II (Dimethylarginine Dimethylaminohydrolase)- Polymorphism in Patients With Severe Sepsis and Septic Shock as Prognostic Value
- ClinicalTrials.gov ID
- NCT01632059
- Acronym / sponsor ID
- ADSeS / ADSeS (PV3927)
- Conditions
- Septic Shock, Sepsis
- Keywords
- ADMA, DDAH II, SAPS, SOFA, Sepsis, Procalcitonin, ICU, mortality
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Universitätsklinikum Hamburg-EppendorfUniversity, hospital or other
- Study start
- Feb 2012 (actual)
- Primary completion
- Mar 2013 (actual)
- Study completion
- Apr 2017 (actual)
- First posted
- 29 Jun 2012 (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.
Examination of ADMA (Asymmetric-Dimethylarginine)-serum level and DDAH II (Dimethylarginine Dimethylaminohydrolase)- Polymorphism in patients with severe Sepsis and septic shock as prognostic value.
This study looks into ADMA as a good prognostic factor for sepsis. Further more the dependency of the ADMA level to the DDAH II polymorphisms is reviewed this study.
Detailed description
Secondary targets are the mortality (28 days ICU), the length of hospitalisation in ICU and peripheral station, the severity of the illness (SAPS II score), the SOFA-score values in the progress and the procalcitonin values in the progress
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| septical patients | – | –inclusion criteria are severe sepsis and septical shock and must be > 18 y/o |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients > 18 y/o with sepsis and/or septical shock
Key inclusion criteria (3 listed)
- >18 y/o
- sepsis
- septical shock
Key exclusion criteria (5 listed)
- primary cardiogenic shock
- pregnancy
- breastfeeding
- non compliance
- moribund status
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
ADMA serum levels
Time frame: 7 days
measuring of ADMA serum levels on day 1, 3, 7
4 secondary outcomes
28 day mortality
Time frame: 28 day
hospitalisation (ICU and peripheral)
Time frame: 28 days
severity of illness
Time frame: 28 days
DDAH Ii polymorphism
Time frame: 28 days
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 3 Aug 2017.
- Related InfoLink provided by the sponsor.
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Septic Shock
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.
Stefan Kluge, Priv.-Doz. study director
Director of critical care center
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 Septic Shock and Sepsis, run by Universitätsklinikum Hamburg-Eppendorf 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 3 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 3 Aug 2017. 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.
What does the primary outcome measure?
ADMA serum levels (time frame: 7 days). It is what the study was designed to measure, not a finding.
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 3 Aug 2017; AzTrials last refreshed its copy on 7 Nov 2026.