NCT04265404

Brief Summary

The aim of the study is to look if Quick Sequential Organ Failure Assessment Score score in detecting a eary Sepsis is afflicted by neurosurgical disorders

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2018

Geographic Reach
1 country

1 active site

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

August 20, 2018

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 20, 2019

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 16, 2019

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2019

Completed
3 months until next milestone

First Posted

Study publicly available on registry

February 11, 2020

Completed
Last Updated

February 11, 2020

Status Verified

February 1, 2020

Enrollment Period

1 year

First QC Date

October 16, 2019

Last Update Submit

February 8, 2020

Conditions

Brain InjuriesBrain TraumaSubarachnoid Hemorrhage

Outcome Measures

Primary Outcomes (1)

  • Baseline measurement of qSOFA at admission to ICU

    assessment of qSOFA (Quick Sequential Organ Failure Assessment Score)

    Measurement at the time of admission to the intensive care unit

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

All patients brought to the ICU with Inclusion Citeria.

You may qualify if:

  • Subarachnoidal Bleeding
  • Traumatic brain injury
  • Spondylodiszitis

You may not qualify if:

  • intubated before income
  • Age under 16

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Johann Wolfgang Goethe Universität

Frankfurt am Main, Hesse, 60598, Germany

Location

MeSH Terms

Conditions

Brain InjuriesBrain Injuries, TraumaticSubarachnoid Hemorrhage

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and InjuriesIntracranial HemorrhagesCerebrovascular DisordersVascular DiseasesCardiovascular DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Jürgen Konczalla, Prof.

    Johann Wolfgang Goethe Universität

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

October 16, 2019

First Posted

February 11, 2020

Study Start

August 20, 2018

Primary Completion

August 20, 2019

Study Completion

October 31, 2019

Last Updated

February 11, 2020

Record last verified: 2020-02

Locations

DE(1)