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Examination of ADMA (Asymmetric-dimethylarginine)-Serum Level and DDAH II (Dimethylarginine Dimethylaminohydrolase)- Polymorphism in Patients With Severe Sepsis and Septic Shock as Prognostic Value (ADSeS)

This study is currently recruiting participants.
Verified June 2012 by Universitätsklinikum Hamburg-Eppendorf
Sponsor:
Information provided by (Responsible Party):
Universitätsklinikum Hamburg-Eppendorf
ClinicalTrials.gov Identifier:
NCT01632059
First received: March 13, 2012
Last updated: June 28, 2012
Last verified: June 2012
History of Changes
  Purpose

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
Septic Shock
Sepsis

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:

MedlinePlus related topics: Sepsis Shock
U.S. FDA Resources

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: October 2013
Estimated Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
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

  Eligibility

Ages Eligible for Study:   18 Years and older
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

Criteria

Inclusion Criteria:

  • >18 y/o
  • sepsis
  • septical shock

Exclusion Criteria:

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

Contacts
Contact: Rainer Boeger, Professor 00149 40 7410 ext 53178 bremer@uke.de
Contact: Stefan Kluge, P.D. 00149 40 7410 ext 35315 s.kluge@uke.de

Locations
Germany
Universitätskrankenhaus Hamburg Eppendorf Recruiting
Hamburg, Germany, 20246
Contact: Stefan Kluge, P.D./MD     00149 40 7410 ext 35315     s.kluge@uke.de    
Contact: Rainer Boeger, Professor/MD     00149 40 7410 ext 53178     bremer@uke.de    
Principal Investigator: Stefan Kluge, P.D./ MD            
Sponsors and Collaborators
Universitätsklinikum Hamburg-Eppendorf
Investigators
Study Director: Stefan Kluge, Priv.-Doz. Director of critical care center
  More Information

Additional Information:
Related Info  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Universitätsklinikum Hamburg-Eppendorf
ClinicalTrials.gov Identifier: NCT01632059     History of Changes
Other Study ID Numbers: ADSeS (PV3927)
Study First Received: March 13, 2012
Last Updated: June 28, 2012
Health Authority: Germany: German Institute of Medical Documentation and Information

Keywords provided by Universitätsklinikum Hamburg-Eppendorf:
ADMA
DDAH II
SAPS
SOFA
Sepsis
 Procalcitonin
ICU
mortality
length of stay

Additional relevant MeSH terms:
Sepsis
Toxemia
Shock
Shock, Septic
Infection
Systemic Inflammatory Response Syndrome
 Inflammation
Pathologic Processes
N,N-dimethylarginine
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013