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Examination of ADMA Serum Level and DDAH II (ADSeS)

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ClinicalTrials.gov Identifier: NCT01632059
Recruitment Status : Completed
First Posted : June 29, 2012
Last Update Posted : August 3, 2017
Sponsor:
Information provided by (Responsible Party):
Universitätsklinikum Hamburg-Eppendorf

Tracking Information
First Submitted Date March 13, 2012
First Posted Date June 29, 2012
Last Update Posted Date August 3, 2017
Actual Study Start Date February 2012
Actual Primary Completion Date March 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 28, 2012)
ADMA serum levels [ Time Frame: 7 days ]
measuring of ADMA serum levels on day 1, 3, 7
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT01632059 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: June 28, 2012)
  • 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 ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Examination of ADMA Serum Level and DDAH II
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
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.

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
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Whole blood
Sampling Method Non-Probability Sample
Study Population Patients > 18 y/o with sepsis and/or septical shock
Condition
  • Septic Shock
  • Sepsis
Intervention Not Provided
Study Groups/Cohorts septical patients
inclusion criteria are severe sepsis and septical shock and must be > 18 y/o
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: June 28, 2012)
120
Original Estimated Enrollment Same as current
Actual Study Completion Date April 2017
Actual Primary Completion Date March 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • >18 y/o
  • sepsis
  • septical shock

Exclusion Criteria:

  • primary cardiogenic shock
  • pregnancy
  • breastfeeding
  • non compliance
  • moribund status
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Germany
Removed Location Countries  
 
Administrative Information
NCT Number NCT01632059
Other Study ID Numbers ADSeS (PV3927)
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Universitätsklinikum Hamburg-Eppendorf
Study Sponsor Universitätsklinikum Hamburg-Eppendorf
Collaborators Not Provided
Investigators
Study Director: Stefan Kluge, Priv.-Doz. Director of critical care center
PRS Account Universitätsklinikum Hamburg-Eppendorf
Verification Date August 2017