Brain InjuriesNCT04265404
Evaluation of qSOFA in Neurosurgical Patients
An observational study of Brain Injuries and Brain Trauma, run by Goethe University at 1 site in Germany.
Trial 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 Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Brain Injuries, Brain Trauma, Subarachnoid Hemorrhage
- How many people
- 100 participants
- Where
- 1 siteGermany
- Study dates
- 20 Aug 2018to 31 Oct 2019
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patients brought to the ICU with Inclusion Citeria.
Who may be able to join
- Subarachnoidal Bleeding
- Traumatic brain injury
- Spondylodiszitis
Who cannot join
- intubated before income
- Age under 16
Trial locations and contacts
1 site in 1 country.
Germany1 site
Johann Wolfgang Goethe Universität
Frankfurt am Main, Hesse, 60598
About this study
Official title: Prospective Evaluation of qSOFA (Quick Sequential Organ Failure Assessment Score) to Detect Systemic Infection in Neurosurgical Patients
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
- Conditions
- Brain Injuries, Brain Trauma, Subarachnoid Hemorrhage
- Medical subject headings
- Brain Injuries, Brain Injuries, Traumatic, Subarachnoid Hemorrhage
What is being measured
The primary outcome is the main question the study is designed to answer.
Baseline measurement of qSOFA at admission to ICU
assessment of qSOFA (Quick Sequential Organ Failure Assessment Score)
Measured: Measurement at the time of admission to the intensive care unit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2020
- Study start20 Aug 2018
- Primary completion20 Aug 2019
- Study completion31 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brain InjuriesStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Goethe University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elisabeth H. Adam, Goethe University
- Investigators
- Jürgen Konczalla, Prof., Principal investigator, Johann Wolfgang Goethe Universität
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04265404
- Sponsor's protocol ID
- 75/18
- Status last verified
- Feb 2020
- First submitted
- 16 Oct 2019
- Last updated
- 11 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Evaluation of qSOFA (Quick Sequential Organ Failure Assessment Score) to Detect Systemic Infection in Neurosurgical Patients
- ClinicalTrials.gov ID
- NCT04265404
- Acronym / sponsor ID
- 75/18
- Conditions
- Brain Injuries, Brain Trauma, Subarachnoid Hemorrhage
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Goethe UniversityUniversity, hospital or other
- Study start
- 20 Aug 2018 (actual)
- Primary completion
- 20 Aug 2019 (actual)
- Study completion
- 31 Oct 2019 (actual)
- First posted
- 11 Feb 2020 (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 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
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients brought to the ICU with Inclusion Citeria.
Key inclusion criteria (3 listed)
- Subarachnoidal Bleeding
- Traumatic brain injury
- Spondylodiszitis
Key exclusion criteria (2 listed)
- intubated before income
- Age under 16
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Baseline measurement of qSOFA at admission to ICU
Time frame: Measurement at the time of admission to the intensive care unit
assessment of qSOFA (Quick Sequential Organ Failure Assessment Score)
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 11 Feb 2020.
- Individual participant dataSharing planned: Undecided
Related trials for Brain Injuries
Not yet recruiting
Feasibility of a Robot-Guided Active Play Intervention for Children With Cerebral Palsy
Cerebral Palsy
Recruiting
Additional Effects on tDCS With AOT on Lower Limb Functions on Children With Diplegic CP
Diplegic Cerebral Palsy
Recruiting
Sensory Integration Therapy vs Conventional Physical Therapy in Children With Mixed Cerebral Palsy
Cerebral Palsy
Recruiting
Telerehabilitation Compared With Clinic-Based Physiotherapy in Children With Spastic Cerebral Palsy
Spastic Cerebral Palsy
Active, not recruitingObservational study
Transforming Research and Clinical Knowledge in Traumatic Brain Injury Epileptogenesis Project (TRACK-TBI EPI)
Traumatic Brain Injury, Post-traumatic Epilepsy
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.
Jürgen Konczalla, Prof. principal investigator
Johann Wolfgang Goethe Universität
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 Brain Injuries and Brain Trauma, 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 3 inclusion and 2 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 11 Feb 2020. 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?
Baseline measurement of qSOFA at admission to ICU (time frame: Measurement at the time of admission to the intensive care unit). 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 11 Feb 2020.