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Examination of ADMA Serum Level and DDAH II (ADSeS)

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Universitätsklinikum Hamburg-Eppendorf Identifier:
First received: March 13, 2012
Last updated: December 4, 2015
Last verified: December 2015

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.

Septic Shock

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by NLM:

Further study details as provided by Universitätsklinikum Hamburg-Eppendorf:

Primary Outcome Measures:
  • ADMA serum levels [ Time Frame: 7 days ] [ Designated as safety issue: No ]
    measuring of ADMA serum levels on day 1, 3, 7

Secondary Outcome Measures:
  • 28 day mortality [ Time Frame: 28 day ] [ Designated as safety issue: No ]
  • hospitalisation (ICU and peripheral) [ Time Frame: 28 days ] [ Designated as safety issue: No ]
  • severity of illness [ Time Frame: 28 days ] [ Designated as safety issue: No ]
  • DDAH Ii polymorphism [ Time Frame: 28 days ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA
Whole blood

Estimated Enrollment: 120
Study Start Date: February 2012
Estimated Study Completion Date: June 2016
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
septical patients
inclusion criteria are severe sepsis and septical shock and must be > 18 y/o

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

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients > 18 y/o with sepsis and/or septical shock

Inclusion Criteria:

  • >18 y/o
  • sepsis
  • septical shock

Exclusion Criteria:

  • primary cardiogenic shock
  • pregnancy
  • breastfeeding
  • non compliance
  • moribund status
  Contacts and Locations
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Please refer to this study by its identifier: NCT01632059

Universitätskrankenhaus Hamburg Eppendorf
Hamburg, Germany, 20246
Sponsors and Collaborators
Universitätsklinikum Hamburg-Eppendorf
Study Director: Stefan Kluge, Priv.-Doz. Director of critical care center
  More Information

Additional Information:
Responsible Party: Universitätsklinikum Hamburg-Eppendorf Identifier: NCT01632059     History of Changes
Other Study ID Numbers: ADSeS (PV3927) 
Study First Received: March 13, 2012
Last Updated: December 4, 2015
Health Authority: Germany: German Institute of Medical Documentation and Information

Keywords provided by Universitätsklinikum Hamburg-Eppendorf:
length of stay

Additional relevant MeSH terms:
Shock, Septic
Systemic Inflammatory Response Syndrome
Pathologic Processes
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action processed this record on October 21, 2016