NCT02692118

Brief Summary

Sepsis is still a challenge for clinicians since the detailed pathomechanism are still unknown and until now early markers for sepsis are not defined yet. Immunological pathways and new mediators defined in animal models are not yet investigated in patients with sepsis. Therefore the investigators will measure new mediators in patients with septic shock.

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
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2016

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

First Submitted

Initial submission to the registry

February 22, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 25, 2016

Completed
9 months until next milestone

Study Start

First participant enrolled

December 1, 2016

Completed
5.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2022

Completed
Last Updated

June 7, 2021

Status Verified

June 1, 2021

Enrollment Period

5.5 years

First QC Date

February 22, 2016

Last Update Submit

June 4, 2021

Conditions

Inflammation

Outcome Measures

Primary Outcomes (1)

  • Semaphorin 1 to 7 in plasma of septic patients

    Concentration of Semaphorin in plasma of 60 sepsis patients \[pg/ml\].

    12 months

Study Arms (1)

sepsis

Patients with septic shock admitted to ICU

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Intensive Care patients with septic shock

You may qualify if:

  • Septic Shock

You may not qualify if:

  • Age \< 18 \> 85
  • no consent of caregiver
  • Trauma patients
  • Burn patients
  • Immunosuppression
  • Pregnancy
  • HIV- hepatitis infection

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Tuebingen

Tübingen, 72076, Germany

RECRUITING

Related Publications (1)

  • Granja T, Kohler D, Tang L, Burkard P, Eggstein C, Hemmen K, Heinze KG, Heck-Swain KL, Koeppen M, Gunther S, Blaha M, Magunia H, Bamberg M, Konrad F, Ngamsri KC, Fuhr A, Keller M, Bernard AM, Haeberle HA, Bakchoul T, Zarbock A, Nieswandt B, Rosenberger P. Semaphorin 7A coordinates neutrophil response during pulmonary inflammation and sepsis. Blood Adv. 2024 Jun 11;8(11):2660-2674. doi: 10.1182/bloodadvances.2023011778.

    PMID: 38489236DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples

MeSH Terms

Conditions

Inflammation

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Peter Rosenberger, MD

    University Hospital Tuebingen

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Peter Rosenberger, MD

CONTACT

+49(0)7071298peter.rosenberger@med.uni-tuebingen.de

Helene A Haeberle, MD

CONTACT

+49(0)7071298helene.haeberle@med.uni-tuebingen.de

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 22, 2016

First Posted

February 25, 2016

Study Start

December 1, 2016

Primary Completion

June 1, 2022

Study Completion

September 1, 2022

Last Updated

June 7, 2021

Record last verified: 2021-06

Locations

DE(1)