German Lactat Clearance in Severe Sepsis | NCT01929772

Studies
German Lactat Clearance in Severe Sepsis

NCT01929772

Sponsor

RWTH Aachen University

Status

Completed

Last Update Posted

Sep 23, 2015Estimated

Enrollment

300Actual

Phase

Not provided

Conditions

Severe Sepsis
Septic Shock

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

Sep 2015

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

Sep 2012

Primary Completion Date

Apr 2015Actual

Completion Date

Apr 2015Actual

First Submitted Date

Aug 19, 2013

First Submission Date that Met QC Criteria

Aug 21, 2013

First Posted Date

Aug 28, 2013Estimated

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

Sep 22, 2015

Last Update Posted Date

Sep 23, 2015Estimated

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

The aim of this study is to investigate if there is a correlation between lactate clearance and the course at patients with severe sepsis and septic shock at german intensive care units.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

300Actual

Label	Type	Description	Intervention Names
severe sepsis or septic shock		patients with severe sepsis or septic shock

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Lactate Clearance	Determination of lactate clearance within 6 hours after diagnosis of severe sepisis and septic shocik	Within 6 hours after diagnoses

Secondary Outcomes

Measure	Description	Time Frame
SOFA Score		Day of hospitalization, day 7, day 8

Other Outcomes

Measure	Description	Time Frame
Mortality	Determination of the mortality of the collective after 28 days	After 28 days
Duration intensive care unit and hospitalization		28 days

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with severe sepsis or septic shock
signed informed consent

Exclusion Criteria:

severe sepsis or septic schock within 4 weeks before inclusion of study
shock of other genesis
persons being accomondated in an institution because of court or official order
persons being interdependet to the investigator
employees of the investigator

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

Patients with severe sepsis or septic shock

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Department for Operative Intensive Care and Intermediate Care - University Hospital Aachen		Aachen	North Rhine Westfalia	52074	Germany

Condition Browse Module

MeSH Terms

ID	Term
D018805	Sepsis
D012772	Shock, Septic

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided