NCT03280576

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

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
556

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2015

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2015

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

November 19, 2015

Completed
1.8 years until next milestone

First Posted

Study publicly available on registry

September 12, 2017

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2019

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2019

Completed
Last Updated

August 15, 2019

Status Verified

August 1, 2019

Enrollment Period

4 years

First QC Date

November 19, 2015

Last Update Submit

August 13, 2019

Conditions

Keywords

PostoperativeDysfunction Following Cardiac Surgery

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

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

Study Sites (2)

Department of Anesthesiology, LMU Munich

Munich, Bavaria, 81377, Germany

Location

Department of Anesthesiology, Klinikum Neuperlach

Munich, Bavaria, 81737, Germany

Location

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.

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum, EDTA blood, blood cells (PAXGENE)

MeSH Terms

Conditions

Sepsis

Condition Hierarchy (Ancestors)

InfectionsSystemic Inflammatory Response SyndromeInflammationPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Gustav Schelling, M.D.

    Department of Anaesthesiology LMU

    PRINCIPAL INVESTIGATOR

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

Locations