Third Degree BurnEarlygnostNCT01055587
Diagnostic of Infections Following Major Abdominal Surgery and Burn Injury
An observational study of Third Degree Burn and Second Degree Burn, run by Klinikum St. Georg gGmbH at 1 site in Germany.
Trial summary
This study was designed to investigate, if new biomarkers may improve the early diagnostic of infections following major abdominal surgery and severe burn injuries. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Third Degree Burn, Second Degree Burn
- How many people
- 120 participants
- Where
- 1 siteGermany
- Study dates
- Sep 2009to Jun 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Group 1: patients who undergo major abdominal surgery Group 2: patients following severe burn injury
Who may be able to join
- patients with major abdominal surgery (e.g. gastrectomy, hemi-/colectomy, resection of sigma or rectum, resection of liver, esophagectomy)
- patients following severe burn injury (burn surface area >= 15%)
- age >= 18 years
- informed consent
Who cannot join
- no informed consent
- emergency surgery
- immunocompromising diseases (e.g. HIV+, AIDS, Lymphoma or NonHodgkin-Lymphoma, Autoimmune-Diseases)
- pre-existing liver or renal failure
- chronic therapy with corticoids
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Impact of Biomarkers for Early Diagnostic of Infections Following Major Abdominal Surgery and Severe Burn Injuries
This study was designed to investigate, if new biomarkers may improve the early diagnostic of infections following major abdominal surgery and severe burn injuries.
- Conditions
- Third Degree Burn, Second Degree Burn
- Keywords
- major abdominal surgery, severe burn injury, infection, diagnostic
- Medical subject headings
- Burns, Infections, Disease
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 |
|---|---|---|
| major abdominal surgery | The investigators compare the levels of biomarkers in patients with and without complications in the early postoperative course following major abdominal surgery | |
| severe burn injury | The investigators compare levels of biomarkers within the first 20 days in patients with and without complications following severe burn injury |
What is being measured
The primary outcome is the main question the study is designed to answer.
rate of infections
Measured: day 28 post intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jan 2010 (estimated)
- Study startSep 2009
- Primary completionJun 2015
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Third Degree BurnStudies 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
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- Klinikum St. Georg gGmbH
- Sponsor type
- University, hospital or other
- Collaborators
- Martin-Luther-Universität Halle-Wittenberg
- Responsible party
- Principal investigator, Armin Sablotzki, MD, Klinikum St. Georg gGmbH
- Investigators
- Armin R Sablotzki, MD, Principal investigator, Klinikum St. Georg gGmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01055587
- Sponsor's protocol ID
- EK-BR-29/09-1
- Other IDs
- Stu09/0031
- Acronym
- Earlygnost
- Status last verified
- Feb 2017
- First submitted
- 22 Jan 2010
- Last updated
- 8 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Gille J, Schmidt J, Kremer T, Sablotzki A. Evaluation of MR-proANP and copeptin for sepsis diagnosis after burn injury. J Crit Care. 2019 Aug;52:149-155. doi: 10.1016/j.jcrc.2019.04.031. Epub 2019 Apr 30.
PubMed 31075618Gille J, Ostermann H, Dragu A, Sablotzki A. MR-proADM: A New Biomarker for Early Diagnosis of Sepsis in Burned Patients. J Burn Care Res. 2017 Sep/Oct;38(5):290-298. doi: 10.1097/BCR.0000000000000508.
PubMed 28221298
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Biomarkers for Early Diagnostic of Infections Following Major Abdominal Surgery and Severe Burn Injuries
- ClinicalTrials.gov ID
- NCT01055587
- Acronym / sponsor ID
- Earlygnost / EK-BR-29/09-1
- Conditions
- Third Degree Burn, Second Degree Burn
- Keywords
- major abdominal surgery, severe burn injury, infection, diagnostic
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- Klinikum St. Georg gGmbHUniversity, hospital or other
- Collaborators
- Martin-Luther-Universität Halle-Wittenberg
- Study start
- Sep 2009
- Primary completion
- Jun 2015 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 25 Jan 2010 (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.
This study was designed to investigate, if new biomarkers may improve the early diagnostic of infections following major abdominal surgery and severe burn injuries.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| major abdominal surgery | – | –The investigators compare the levels of biomarkers in patients with and without complications in the early postoperative course following major abdominal surgery |
| severe burn injury | – | –The investigators compare levels of biomarkers within the first 20 days in patients with and without complications following severe burn injury |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Group 1: patients who undergo major abdominal surgery Group 2: patients following severe burn injury
Key inclusion criteria (4 listed)
- patients with major abdominal surgery (e.g. gastrectomy, hemi-/colectomy, resection of sigma or rectum, resection of liver, esophagectomy)
- patients following severe burn injury (burn surface area >= 15%)
- age >= 18 years
- informed consent
Key exclusion criteria (5 listed)
- no informed consent
- emergency surgery
- immunocompromising diseases (e.g. HIV+, AIDS, Lymphoma or NonHodgkin-Lymphoma, Autoimmune-Diseases)
- pre-existing liver or renal failure
- chronic therapy with corticoids
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
rate of infections
Time frame: day 28 post intervention
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 8 Feb 2017.
- Derived from this study: PubMed 31075618Gille J, Schmidt J, Kremer T, Sablotzki A. Evaluation of MR-proANP and copeptin for sepsis diagnosis after burn injury. J Crit Care. 2019 Aug;52:149-155. doi: 10.1016/j.jcrc.2019.04.031. Epub 2019 Apr 30.
- Derived from this study: PubMed 28221298Gille J, Ostermann H, Dragu A, Sablotzki A. MR-proADM: A New Biomarker for Early Diagnosis of Sepsis in Burned Patients. J Burn Care Res. 2017 Sep/Oct;38(5):290-298. doi: 10.1097/BCR.0000000000000508.
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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.
Armin R Sablotzki, MD principal investigator
Klinikum St. Georg gGmbH
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 Third Degree Burn and Second Degree Burn, run by Klinikum St. Georg gGmbH 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 4 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 8 Feb 2017. 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?
rate of infections (time frame: day 28 post intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01055587, which also lists 2 linked publications.
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 8 Feb 2017.