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Examination of ADMA Serum Level and DDAH II (ADSeS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01632059
Recruitment Status : Completed
First Posted : June 29, 2012
Last Update Posted : August 3, 2017
Information provided by (Responsible Party):
Universitätsklinikum Hamburg-Eppendorf

Brief 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. Further more the dependency of the ADMA level to the DDAH II polymorphisms is reviewed this study.

Condition or disease
Septic Shock Sepsis

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

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Study Type : Observational
Actual Enrollment : 120 participants
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
Actual Study Start Date : February 2012
Actual Primary Completion Date : March 2013
Actual Study Completion Date : April 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sepsis Shock

septical patients
inclusion criteria are severe sepsis and septical shock and must be > 18 y/o

Primary Outcome Measures :
  1. ADMA serum levels [ Time Frame: 7 days ]
    measuring of ADMA serum levels on day 1, 3, 7

Secondary Outcome Measures :
  1. 28 day mortality [ Time Frame: 28 day ]
  2. hospitalisation (ICU and peripheral) [ Time Frame: 28 days ]
  3. severity of illness [ Time Frame: 28 days ]
  4. DDAH Ii polymorphism [ Time Frame: 28 days ]

Biospecimen Retention:   Samples With DNA
Whole blood

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01632059

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

Additional Information:
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Responsible Party: Universitätsklinikum Hamburg-Eppendorf Identifier: NCT01632059    
Other Study ID Numbers: ADSeS (PV3927)
First Posted: June 29, 2012    Key Record Dates
Last Update Posted: August 3, 2017
Last Verified: August 2017
Keywords provided by Universitätsklinikum Hamburg-Eppendorf:
length of stay
Additional relevant MeSH terms:
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Shock, Septic
Systemic Inflammatory Response Syndrome
Pathologic Processes