Severe SepsisGLASSNCT01929772
German Lactat Clearance in Severe Sepsis
An observational study of Severe Sepsis and Septic Shock, run by RWTH Aachen University at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Severe Sepsis, Septic Shock
- How many people
- 300 participants
- Where
- 1 siteGermany
- Study dates
- Sep 2012to Apr 2015
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with severe sepsis or septic shock
Who may be able to join
- Patients with severe sepsis or septic shock
- signed informed consent
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department for Operative Intensive Care and Intermediate Care - University Hospital Aachen
Aachen, North Rhine Westfalia, 52074
About this study
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.
- Conditions
- Severe Sepsis, Septic Shock
- Medical subject headings
- Sepsis, Shock, Septic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| severe sepsis or septic shock | patients with severe sepsis or septic shock |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lactate Clearance
Determination of lactate clearance within 6 hours after diagnosis of severe sepisis and septic shocik
Measured: Within 6 hours after diagnoses
Secondary outcomes (1)
SOFA Score
Measured: Day of hospitalization, day 7, day 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2013 (estimated)
- Study startSep 2012
- Primary completionApr 2015
- Study completionApr 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Severe SepsisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Lead sponsor
- RWTH Aachen University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01929772
- Sponsor's protocol ID
- 12-052
- Acronym
- GLASS
- Status last verified
- Sep 2015
- First submitted
- 19 Aug 2013
- Last updated
- 23 Sep 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- German Lactat Clearance in Severe Sepsis
- ClinicalTrials.gov ID
- NCT01929772
- Acronym / sponsor ID
- GLASS / 12-052
- Conditions
- Severe Sepsis, Septic Shock
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- RWTH Aachen UniversityUniversity, hospital or other
- Study start
- Sep 2012
- Primary completion
- Apr 2015 (actual)
- Study completion
- Apr 2015 (actual)
- First posted
- 28 Aug 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| severe sepsis or septic shock | – | –patients with severe sepsis or septic shock |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with severe sepsis or septic shock
Key inclusion criteria (2 listed)
- Patients with severe sepsis or septic shock
- signed informed consent
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Lactate Clearance
Time frame: Within 6 hours after diagnoses
Determination of lactate clearance within 6 hours after diagnosis of severe sepisis and septic shocik
1 secondary outcome
SOFA Score
Time frame: Day of hospitalization, day 7, day 8
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2015.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Severe Sepsis and Septic Shock, run by RWTH Aachen University at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Lactate Clearance (time frame: Within 6 hours after diagnoses). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Sep 2015.