Examination of ADMA Serum Level and DDAH II (ADSeS)

August 2, 2017 updated by: Universitätsklinikum Hamburg-Eppendorf

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

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.

Study Overview

Status

Completed

Conditions

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

Enrollment (Actual)

120

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Hamburg, Germany, 20246
        • Universitätskrankenhaus Hamburg Eppendorf

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients > 18 y/o with sepsis and/or septical shock

Description

Inclusion Criteria:

  • >18 y/o
  • sepsis
  • septical shock

Exclusion Criteria:

  • primary cardiogenic shock
  • pregnancy
  • breastfeeding
  • non compliance
  • moribund status

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ADMA serum levels
Time Frame: 7 days
measuring of ADMA serum levels on day 1, 3, 7
7 days

Secondary Outcome Measures

Outcome Measure
Time Frame
28 day mortality
Time Frame: 28 day
28 day
hospitalisation (ICU and peripheral)
Time Frame: 28 days
28 days
severity of illness
Time Frame: 28 days
28 days
DDAH Ii polymorphism
Time Frame: 28 days
28 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universitätsklinikum Hamburg-Eppendorf

Investigators

  • Study Director: Stefan Kluge, Priv.-Doz., Director of critical care center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2012

Primary Completion (Actual)

March 1, 2013

Study Completion (Actual)

April 1, 2017

Study Registration Dates

First Submitted

March 13, 2012

First Submitted That Met QC Criteria

June 28, 2012

First Posted (Estimate)

June 29, 2012

Study Record Updates

Last Update Posted (Actual)

August 3, 2017

Last Update Submitted That Met QC Criteria

August 2, 2017

Last Verified

August 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ADSeS (PV3927)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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