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Examination of ADMA Serum Level and DDAH II (ADSeS)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01632059
First Posted: June 29, 2012
Last Update Posted: August 3, 2017
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.
Information provided by (Responsible Party):
Universitätsklinikum Hamburg-Eppendorf
  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 ]
    measuring of ADMA serum levels on day 1, 3, 7


Secondary Outcome Measures:
  • 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 ]

Biospecimen Retention:   Samples With DNA
Whole blood

Enrollment: 120
Actual Study Start Date: February 2012
Study Completion Date: April 2017
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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
Criteria

Inclusion Criteria:

  • >18 y/o
  • sepsis
  • septical shock

Exclusion Criteria:

  • primary cardiogenic shock
  • pregnancy
  • breastfeeding
  • non compliance
  • moribund status
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): 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:
Responsible Party: Universitätsklinikum Hamburg-Eppendorf
ClinicalTrials.gov Identifier: NCT01632059     History of Changes
Other Study ID Numbers: ADSeS (PV3927)
First Submitted: March 13, 2012
First Posted: June 29, 2012
Last Update Posted: August 3, 2017
Last Verified: August 2017

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

Additional relevant MeSH terms:
Sepsis
Shock, Septic
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes
Shock