Examination of ADMA Serum Level and DDAH II | NCT01632059

Studies
Examination of ADMA Serum Level and DDAH II

NCT01632059

Sponsor

Universitätsklinikum Hamburg-Eppendorf

Status

Completed

Last Update Posted

Aug 3, 2017Actual

Enrollment

120Actual

Phase

Not provided

Conditions

Septic Shock
Sepsis

Interventions

Not provided

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2012Actual

Primary Completion Date

Mar 2013Actual

Completion Date

Apr 2017Actual

First Submitted Date

Mar 13, 2012

First Submission Date that Met QC Criteria

Jun 28, 2012

First Posted Date

Jun 29, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 2, 2017

Last Update Posted Date

Aug 3, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

120Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
septical patients		inclusion criteria are severe sepsis and septical shock and must be > 18 y/o

Interventions

Not provided

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
28 day mortality		28 day
hospitalisation (ICU and peripheral)		28 days
severity of illness

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

>18 y/o
sepsis
septical shock

Exclusion Criteria:

primary cardiogenic shock
pregnancy
breastfeeding
non compliance
moribund status

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Stefan Kluge, Priv.-Doz.	Director of critical care center	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Universitätskrankenhaus Hamburg Eppendorf		Hamburg		20246	Germany

Label	URL
Related Info	View source

Condition Browse Module

MeSH Terms

ID	Term
D012772	Shock, Septic
D018805	Sepsis

Ancestor Terms

ID	Term
D007239	Infections
D018746	Systemic Inflammatory Response Syndrome
D007249	Inflammation
D010335	Pathologic Processes

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Browse Branches

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