NCT05246969

Brief Summary

The study aims to evaluate the suitability of the SOFA score implemented by the Sepsis 3 guideline to detect sepsis in patients suffering from subrarachnoid hemorrhage.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
58

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2017

Longer than P75 for all trials

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

June 1, 2017

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2018

Completed
3.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2022

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

February 9, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 18, 2022

Completed
Last Updated

March 29, 2022

Status Verified

March 1, 2022

Enrollment Period

1 year

First QC Date

February 9, 2022

Last Update Submit

March 14, 2022

Conditions

Keywords

sequential organ failure assessment score

Outcome Measures

Primary Outcomes (2)

  • Sepsis SOFA positive

    Sepsis correctly detected by SOFA score (Sepsis-related organ failure assessment score, 0-24 points)

    up to 2 months

  • Sepsis SOFA negative

    Sepsis not detected by SOFA score (Sepsis-related organ failure assessment score, 0-24 points)

    up to 2 months

Interventions

The aim of the study was to observe whether the treating physicians were able to detect sepsis by strictly applying the recommended SOFA score.

Eligibility Criteria

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

Patients with severe subarachnoid hemorrhage requiring intensive care.

You may qualify if:

  • Critically ill patients suffering from moderate to severe subarachnoid hemorrhage (WFNS \>2).

You may not qualify if:

  • children under the age of 18 years Patients with minor subarachnoid hemorrhage \< WFNS stage 2.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Frankfurt

Niederrad, Hesse, 60590, Germany

Location

MeSH Terms

Conditions

Subarachnoid HemorrhageSystemic Inflammatory Response SyndromeSepsis

Condition Hierarchy (Ancestors)

Intracranial HemorrhagesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesVascular DiseasesCardiovascular DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and SymptomsInflammationShockInfections

Study Design

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

Study Record Dates

First Submitted

February 9, 2022

First Posted

February 18, 2022

Study Start

June 1, 2017

Primary Completion

June 1, 2018

Study Completion

February 1, 2022

Last Updated

March 29, 2022

Record last verified: 2022-03

Data Sharing

IPD Sharing
Will not share

The dataset will be published in an international journal. The data will be available upon reasonable request from the corresponding author

Locations