NCT01535534

Brief Summary

During the past years many investigators have focused on the immunological changes in sepsis disease, and great attention has been paid to the development of practicable means of immunomonitoring. Little is known about diagnostic and prognostic vascular biomarkers during the time course of patients with sepsis.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
250

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2012

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

January 1, 2012

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

February 14, 2012

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 17, 2012

Completed
6.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2018

Completed
3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2021

Completed
Last Updated

August 27, 2020

Status Verified

August 1, 2020

Enrollment Period

6.9 years

First QC Date

February 14, 2012

Last Update Submit

August 26, 2020

Conditions

Sepsis

Keywords

sepsisinflammationdiagnosisprognosissurvivalmortality

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients suffering from sepsis

You may qualify if:

  • SIRS-Criteria
  • Proven Infection
  • One sepsis-induced organ-failure
  • Adults \< 18 years old

You may not qualify if:

  • Anemia
  • Pregnancy
  • Blood donor in the last 3 month

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Medical Centre Mannheim

Mannheim, Baden-Wurttemberg, 68167, Germany

Location

Related Publications (2)

  • Hamed S, Behnes M, Pauly D, Lepiorz D, Barre M, Becher T, Lang S, Akin I, Borggrefe M, Bertsch T, Hoffmann U. Diagnostic value of Pentraxin-3 in patients with sepsis and septic shock in accordance with latest sepsis-3 definitions. BMC Infect Dis. 2017 Aug 9;17(1):554. doi: 10.1186/s12879-017-2606-3.

    PMID: 28793880DERIVED

  • Behnes M, Bertsch T, Lepiorz D, Lang S, Trinkmann F, Brueckmann M, Borggrefe M, Hoffmann U. Diagnostic and prognostic utility of soluble CD 14 subtype (presepsin) for severe sepsis and septic shock during the first week of intensive care treatment. Crit Care. 2014 Sep 5;18(5):507. doi: 10.1186/s13054-014-0507-z.

    PMID: 25190134DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Peripheral blood samples

MeSH Terms

Conditions

SepsisInflammationDisease

Condition Hierarchy (Ancestors)

InfectionsSystemic Inflammatory Response SyndromePathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Ursula Hoffmann, MD

    Universitätsmedizin Mannheim

    PRINCIPAL INVESTIGATOR

  • Michael Behnes, MD

    Universitätsmedizin Mannheim

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 14, 2012

First Posted

February 17, 2012

Study Start

January 1, 2012

Primary Completion

December 1, 2018

Study Completion

December 1, 2021

Last Updated

August 27, 2020

Record last verified: 2020-08

Locations

DE(1)