Validation of Progranulin as a Biomarker for Sepsis
PROGRANULIN
Sensitivity and Specificity of Progranulin as a Biomarker for Sepsis
1 other identifier
observational
556
1 country
2
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Apr 2015
Longer than P75 for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2015
CompletedFirst Submitted
Initial submission to the registry
November 19, 2015
CompletedFirst Posted
Study publicly available on registry
September 12, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2019
CompletedAugust 15, 2019
August 1, 2019
4 years
November 19, 2015
August 13, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change in progranulin plasma concentrations during ICU - therapy
Blood samples will be taken at the abovementioned time points
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
ICU admission, day 1, day 4 of ICU therapy
Study Arms (3)
Sepsis
Patients with sepsis
Cardiac Surgery
Patients undergoing cardiac surgery
Healthy controls
Normal individuals
Eligibility Criteria
Patients with Sepsis, Patients undergoing cardiac surgery, Healthy volunteers
You may qualify if:
- Sepsis or Septic Shock defined according to SEPSIS-3 criteria - Age \> 18 years
You may not qualify if:
- No informed consent
- Age \< 18 years
- Pregnancy
- Immunosuppression (including transplantation)
- Charlson Comorbidity Index \> 0 (healthy volunteers)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ludwig-Maximilians - University of Munichlead
- City of Munichcollaborator
Study Sites (2)
Department of Anesthesiology, LMU Munich
Munich, Bavaria, 81377, Germany
Department of Anesthesiology, Klinikum Neuperlach
Munich, Bavaria, 81737, Germany
Related Publications (1)
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.
PMID: 34476621DERIVED
Biospecimen
Serum, EDTA blood, blood cells (PAXGENE)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Gustav Schelling, M.D.
Department of Anaesthesiology LMU
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Senior Researcher
Study Record Dates
First Submitted
November 19, 2015
First Posted
September 12, 2017
Study Start
April 1, 2015
Primary Completion
April 1, 2019
Study Completion
June 1, 2019
Last Updated
August 15, 2019
Record last verified: 2019-08
Data Sharing
- IPD Sharing
- Will not share