SepsisPROGRANULINNCT03280576
Validation of Progranulin as a Biomarker for Sepsis
An observational study of Sepsis, run by Ludwig-Maximilians - University of Munich at 2 sites in Germany.
Trial summary
Progranulin blood concentrations in patients with sepsis will be analysed in relation to disease status in order to validate progranulin as a biomarker for sepsis. Patients undergoing cardiac surgery will serve as controls. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Sepsis
- How many people
- 556 participants
- Where
- 2 sitesGermany
- Study dates
- Apr 2015to Jun 2019
- 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
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with Sepsis, Patients undergoing cardiac surgery, Healthy volunteers
Who may be able to join
- Sepsis or Septic Shock defined according to SEPSIS-3 criteria - Age > 18 years
Who cannot join
- No informed consent
- Age < 18 years
- Pregnancy
- Immunosuppression (including transplantation)
- Charlson Comorbidity Index > 0 (healthy volunteers)
Trial locations and contacts
2 sites in 1 country.
Germany2 sites
Department of Anesthesiology, LMU Munich
Munich, Bavaria, 81377
Department of Anesthesiology, Klinikum Neuperlach
Munich, Bavaria, 81737
About this study
Official title: Sensitivity and Specificity of Progranulin as a Biomarker for Sepsis
Progranulin blood concentrations in patients with sepsis will be analysed in relation to disease status in order to validate progranulin as a biomarker for sepsis. Patients undergoing cardiac surgery will serve as controls.
Read the detailed description
Single nucleotide polymorphisms with known effects on Progranulin plasma concentrations will be assessed in a separate analysis. Expression levels of microRNAs isolated from plasma, circulating exosomes and blood cells will be determined by next-generation sequencing to characterize epigenetic influences on progranulin plasma levels.
- Conditions
- Sepsis
- Keywords
- Postoperative, Dysfunction Following Cardiac Surgery
- Medical subject headings
- Sepsis
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 |
|---|---|---|
| Sepsis | Patients with sepsis | |
| Cardiac Surgery | Patients undergoing cardiac surgery | |
| Healthy controls | Normal individuals |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in progranulin plasma concentrations during ICU - therapy
Blood samples will be taken at the abovementioned time points
Measured: ICU admission, day 1, day 4 of ICU therapy
Secondary outcomes (1)
Change in miRNA expression levels in exosomes, serum and blood cells during ICU - therapy
Blood samples will be taken at the abovementioned time points
Measured: ICU admission, day 1, day 4 of ICU therapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2017
- Study startApr 2015
- Primary completionApr 2019
- Study completionJun 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for 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
- 556 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ludwig-Maximilians - University of Munich
- Sponsor type
- University, hospital or other
- Collaborators
- City of Munich
- Responsible party
- Principal investigator, Gustav Schelling,MD, Ludwig-Maximilians - University of Munich
- Investigators
- Gustav Schelling, M.D., Principal investigator, Department of Anaesthesiology LMU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03280576
- Sponsor's protocol ID
- Progranulin_1
- Acronym
- PROGRANULIN
- Status last verified
- Aug 2019
- First submitted
- 19 Nov 2015
- Last updated
- 15 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Brandes F, Borrmann M, Buschmann D, Meidert AS, Reithmair M, Langkamp M, Pridzun L, Kirchner B, Billaud JN, Amin NM, Pearson JC, Klein M, Hauer D, Gevargez Zoubalan C, Lindemann A, Chouker A, Felbinger TW, Steinlein OK, Pfaffl MW, Kaufmann I, Schelling G. Progranulin signaling in sepsis, community-acquired bacterial pneumonia and COVID-19: a comparative, observational study. Intensive Care Med Exp. 2021 Sep 3;9(1):43. doi: 10.1186/s40635-021-00406-7.
PubMed 34476621
Study at a glance
From the registry record, last updated by the sponsor on 15 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sensitivity and Specificity of Progranulin as a Biomarker for Sepsis
- ClinicalTrials.gov ID
- NCT03280576
- Acronym / sponsor ID
- PROGRANULIN / Progranulin_1
- Conditions
- Sepsis
- Keywords
- Postoperative, Dysfunction Following Cardiac Surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 556 participants (actual)
- Lead sponsor
- Ludwig-Maximilians - University of MunichUniversity, hospital or other
- Collaborators
- City of Munich
- Study start
- Apr 2015 (actual)
- Primary completion
- Apr 2019 (actual)
- Study completion
- Jun 2019 (actual)
- First posted
- 12 Sep 2017 (actual)
- 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.
Progranulin blood concentrations in patients with sepsis will be analysed in relation to disease status in order to validate progranulin as a biomarker for sepsis. Patients undergoing cardiac surgery will serve as controls.
Detailed description
Single nucleotide polymorphisms with known effects on Progranulin plasma concentrations will be assessed in a separate analysis. Expression levels of microRNAs isolated from plasma, circulating exosomes and blood cells will be determined by next-generation sequencing to characterize epigenetic influences on progranulin plasma levels.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Sepsis | – | –Patients with sepsis |
| Cardiac Surgery | – | –Patients undergoing cardiac surgery |
| Healthy controls | – | –Normal individuals |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with Sepsis, Patients undergoing cardiac surgery, Healthy volunteers
Key inclusion criteria (1 listed)
- Sepsis or Septic Shock defined according to SEPSIS-3 criteria - Age > 18 years
Key exclusion criteria (5 listed)
- No informed consent
- Age < 18 years
- Pregnancy
- Immunosuppression (including transplantation)
- Charlson Comorbidity Index > 0 (healthy volunteers)
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
Change in progranulin plasma concentrations during ICU - therapy
Time frame: ICU admission, day 1, day 4 of ICU therapy
Blood samples will be taken at the abovementioned time points
1 secondary outcome
Change in miRNA expression levels in exosomes, serum and blood cells during ICU - therapy
Time frame: ICU admission, day 1, day 4 of ICU therapy
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 15 Aug 2019.
- Derived from this study: PubMed 34476621Brandes F, Borrmann M, Buschmann D, Meidert AS, Reithmair M, Langkamp M, Pridzun L, Kirchner B, Billaud JN, Amin NM, Pearson JC, Klein M, Hauer D, Gevargez Zoubalan C, Lindemann A, Chouker A, Felbinger TW, Steinlein OK, Pfaffl MW, Kaufmann I, Schelling G. Progranulin signaling in sepsis, community-acquired bacterial pneumonia and COVID-19: a comparative, observational study. Intensive Care Med Exp. 2021 Sep 3;9(1):43. doi: 10.1186/s40635-021-00406-7.
- Individual participant dataSharing planned: No
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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.
Gustav Schelling, M.D. principal investigator
Department of Anaesthesiology LMU
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sepsis, run by Ludwig-Maximilians - University of Munich at 2 sites 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 1 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 15 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Change in progranulin plasma concentrations during ICU - therapy (time frame: ICU admission, day 1, day 4 of ICU therapy). 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 NCT03280576, which also lists 1 linked publication.
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 15 Aug 2019; AzTrials last refreshed its copy on 6 Nov 2026.