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OpenTrials
Completed

NCT Number: NCT03280576

Validation 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.

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Key information

Conditions

Sepsis Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Systemic Inflammatory Response Syndrome

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Anesthesiology, Klinikum Neuperlach, Munich, Bavaria, Germany

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Primary outcomes

  1. 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

Secondary outcomes

  1. 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

    Blood samples will be taken at the abovementioned time points

Sponsors and collaborators

Lead sponsor

Ludwig-Maximilians - University of Munich

Other

Collaborators

  • City of Munich

Registry information

Official study title

Sensitivity and Specificity of Progranulin as a Biomarker for Sepsis

Acronym: PROGRANULIN

Important dates

Study start
2015
Primary completion
2019
Study completion
2019
First posted
Sep 12, 2017
Registry last updated
Aug 15, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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