NCT01632059

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2012

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2012

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

March 13, 2012

Completed
4 months until next milestone

First Posted

Study publicly available on registry

June 29, 2012

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
4.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2017

Completed
Last Updated

August 3, 2017

Status Verified

August 1, 2017

Enrollment Period

1.1 years

First QC Date

March 13, 2012

Last Update Submit

August 2, 2017

Conditions

Septic ShockSepsis

Keywords

ADMADDAH IISAPSSOFASepsisProcalcitoninICUmortalitylength of stay

Outcome Measures

Primary Outcomes (1)

  • ADMA serum levels

    measuring of ADMA serum levels on day 1, 3, 7

    7 days

Secondary Outcomes (4)

  • 28 day mortality

    28 day

  • hospitalisation (ICU and peripheral)

    28 days

  • severity of illness

    28 days

  • DDAH Ii polymorphism

    28 days

Study Arms (1)

septical patients

inclusion criteria are severe sepsis and septical shock and must be \> 18 y/o

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • \>18 y/o
  • sepsis
  • septical shock

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Universitätskrankenhaus Hamburg Eppendorf

Hamburg, 20246, Germany

Location

Related Links

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood

MeSH Terms

Conditions

Shock, SepticSepsis

Condition Hierarchy (Ancestors)

InfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsShock

Study Officials

  • Stefan Kluge, Priv.-Doz.

    Director of critical care center

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 13, 2012

First Posted

June 29, 2012

Study Start

February 1, 2012

Primary Completion

March 1, 2013

Study Completion

April 1, 2017

Last Updated

August 3, 2017

Record last verified: 2017-08

Locations

DE(1)