Subarachnoid HemorrhageNCT05246969
Detecting Sepsis in Patients With Severe Subarachnoideal Hemorrhage
An observational study of Subarachnoid Hemorrhage and Subarachnoid Hemorrhage, Aneurysmal, run by Goethe University at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Subarachnoid Hemorrhage, Subarachnoid Hemorrhage, Aneurysmal, Sepsis Syndrome
- What is being tested?
- Sepsis detection
- How many people
- 58 participants
- Where
- 1 siteGermany
- Study dates
- 1 Jun 2017to 1 Feb 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with severe subarachnoid hemorrhage requiring intensive care.
Who may be able to join
- Critically ill patients suffering from moderate to severe subarachnoid hemorrhage (WFNS >2).
Who cannot join
- children under the age of 18 years Patients with minor subarachnoid hemorrhage < WFNS stage 2.
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Subarachnoid Hemorrhage, Subarachnoid Hemorrhage, Aneurysmal, Sepsis Syndrome, Sepsis, Sepsis, Severe, Sepsis Bacterial
- Being tested
- Sepsis detection
- Keywords
- sequential organ failure assessment score
- Medical subject headings
- Subarachnoid Hemorrhage, Systemic Inflammatory Response Syndrome, Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sepsis detectionOther
The aim of the study was to observe whether the treating physicians were able to detect sepsis by strictly applying the recommended SOFA score.
What is being measured
The primary outcome is the main question the study is designed to answer.
Sepsis SOFA positive
Sepsis correctly detected by SOFA score (Sepsis-related organ failure assessment score, 0-24 points)
Measured: up to 2 months
Sepsis SOFA negative
Sepsis not detected by SOFA score (Sepsis-related organ failure assessment score, 0-24 points)
Measured: up to 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2022
- Study start1 Jun 2017
- Primary completion1 Jun 2018
- Study completion1 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Subarachnoid HemorrhageStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- Goethe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Armin N. Flinspach, Goethe University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05246969
- Sponsor's protocol ID
- Sepsis in SAH
- Status last verified
- Mar 2022
- First submitted
- 9 Feb 2022
- Last updated
- 29 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The dataset will be published in an international journal. The data will be available upon reasonable request from the corresponding author
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detecting Sepsis in Patients With Severe Subarachnoideal Hemorrhage
- ClinicalTrials.gov ID
- NCT05246969
- Acronym / sponsor ID
- Sepsis in SAH
- Conditions
- Subarachnoid Hemorrhage, Subarachnoid Hemorrhage, Aneurysmal, Sepsis Syndrome, Sepsis, Sepsis, Severe, Sepsis Bacterial
- Keywords
- sequential organ failure assessment score
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Goethe UniversityUniversity, hospital or other
- Study start
- 1 Jun 2017 (actual)
- Primary completion
- 1 Jun 2018 (actual)
- Study completion
- 1 Feb 2022 (actual)
- First posted
- 18 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with severe subarachnoid hemorrhage requiring intensive care.
Key inclusion criteria (1 listed)
- Critically ill patients suffering from moderate to severe subarachnoid hemorrhage (WFNS >2).
Key exclusion criteria (1 listed)
- children under the age of 18 years Patients with minor subarachnoid hemorrhage < WFNS stage 2.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sepsis detectionThe aim of the study was to observe whether the treating physicians were able to detect sepsis by strictly applying the recommended SOFA score. | Other | – |
Primary outcome
Sepsis SOFA positive
Time frame: up to 2 months
Sepsis correctly detected by SOFA score (Sepsis-related organ failure assessment score, 0-24 points)
Sepsis SOFA negative
Time frame: up to 2 months
Sepsis not detected by SOFA score (Sepsis-related organ failure assessment score, 0-24 points)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2022.
- Individual participant dataSharing planned: No. The dataset will be published in an international journal. The data will be available upon reasonable request from the corresponding author
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Subarachnoid Hemorrhage and Subarachnoid Hemorrhage, Aneurysmal, run by Goethe University at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sepsis SOFA positive (time frame: up to 2 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Mar 2022.