NCT01929772

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2012

Typical duration 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

September 1, 2012

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

August 19, 2013

Completed
9 days until next milestone

First Posted

Study publicly available on registry

August 28, 2013

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2015

Completed
Last Updated

September 23, 2015

Status Verified

September 1, 2015

Enrollment Period

2.6 years

First QC Date

August 19, 2013

Last Update Submit

September 22, 2015

Conditions

Severe SepsisSeptic Shock

Outcome Measures

Primary Outcomes (1)

  • Lactate Clearance

    Determination of lactate clearance within 6 hours after diagnosis of severe sepisis and septic shocik

    Within 6 hours after diagnoses

Secondary Outcomes (1)

  • SOFA Score

    Day of hospitalization, day 7, day 8

Other Outcomes (2)

  • Mortality

    After 28 days

  • Duration intensive care unit and hospitalization

    28 days

Study Arms (1)

severe sepsis or septic shock

patients with severe sepsis or septic shock

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with severe sepsis or septic shock

You may qualify if:

  • Patients with severe sepsis or septic shock
  • signed informed consent

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department for Operative Intensive Care and Intermediate Care - University Hospital Aachen

Aachen, North Rhine Westfalia, 52074, Germany

Location

MeSH Terms

Conditions

SepsisShock, Septic

Condition Hierarchy (Ancestors)

InfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and SymptomsShock

Study Design

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

Study Record Dates

First Submitted

August 19, 2013

First Posted

August 28, 2013

Study Start

September 1, 2012

Primary Completion

April 1, 2015

Study Completion

April 1, 2015

Last Updated

September 23, 2015

Record last verified: 2015-09

Locations

DE(1)