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 ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Universitätsklinikum Hamburg-Eppendorf
ClinicalTrials.gov Identifier:
NCT01632059
First received: March 13, 2012
Last updated: February 26, 2014
Last verified: February 2014
  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:


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: April 2014
Primary Completion Date: March 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01632059

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

Additional Information:
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: February 26, 2014
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 August 28, 2014