Validation of Progranulin as a Biomarker for Sepsis

Sepsis Clinical Trial

— PROGRANULIN  

Official title:

Sensitivity and Specificity of Progranulin as a Biomarker for Sepsis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03280576
• Other study ID #: Progranulin_1
• Status: Completed
• Start date: April 2015
• Est. completion date: June 2019

Study information

• Verified date: August 2019
• Source: Ludwig-Maximilians - University of Munich
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 556
• Est. completion date: June 2019
• Est. primary completion date: April 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Sepsis or Septic Shock defined according to SEPSIS-3 criteria - Age > 18 years

Exclusion Criteria:

• No informed consent

• Age < 18 years

• Pregnancy

• Immunosuppression (including transplantation)

• Charlson Comorbidity Index > 0 (healthy volunteers)

Related Conditions & MeSH terms

• Sepsis
• Toxemia

Locations

Country	Name	City	State
Germany	Department of Anesthesiology, Klinikum Neuperlach	Munich	Bavaria
Germany	Department of Anesthesiology, LMU Munich	Munich	Bavaria

Sponsors (2)

Lead Sponsor	Collaborator
Ludwig-Maximilians - University of Munich	City of Munich

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Change in miRNA expression levels in exosomes, serum and blood cells during ICU - therapy	Blood samples will be taken at the abovementioned time points	ICU admission, day 1, day 4 of ICU therapy