Validation of Progranulin as a Biomarker for Sepsis (PROGRANULIN)

August 13, 2019 updated by: Gustav Schelling,MD, Ludwig-Maximilians - University of Munich

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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

556

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Bavaria
      • Munich, Bavaria, Germany, 81377
        • Department of Anesthesiology, LMU Munich
      • Munich, Bavaria, Germany, 81737
        • Department of Anesthesiology, Klinikum Neuperlach

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Patients with Sepsis, Patients undergoing cardiac surgery, Healthy volunteers

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Sepsis
Patients with sepsis
Cardiac Surgery
Patients undergoing cardiac surgery
Healthy controls
Normal individuals

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
ICU admission, day 1, day 4 of ICU therapy

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
ICU admission, day 1, day 4 of ICU therapy

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ludwig-Maximilians - University of Munich

Collaborators

City of Munich

Investigators

  • Principal Investigator: Gustav Schelling, M.D., Department of Anaesthesiology LMU

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2015

Primary Completion (Actual)

April 1, 2019

Study Completion (Actual)

June 1, 2019

Study Registration Dates

First Submitted

November 19, 2015

First Submitted That Met QC Criteria

September 11, 2017

First Posted (Actual)

September 12, 2017

Study Record Updates

Last Update Posted (Actual)

August 15, 2019

Last Update Submitted That Met QC Criteria

August 13, 2019

Last Verified

August 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Progranulin_1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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