SepsisNCT00410111
Pathogenesis and Cerebrovascular Manifestations of Septic Encephalopathy
An observational study of Sepsis, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
Trial summary
Septic encephalopathy is an important complication of sepsis. Why some patients with sepsis develop septic encephalopathy is unknown. We will investigate whether patients who develop this condition have different patterns of cerebrovascular reactivity and whether it is possible to predict the development of septic… Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Sepsis
- How many people
- 23 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jan 2007to Jul 2007
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with sepsis, severe sepsis or septic shock admitted to an intensive care unit
Who may be able to join
- Sepsis
- Admission to ICU
Who cannot join
- CNS infection
- History of cerebrovascular disease
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Operative Intensivbehandlung, University of Basel Hospital
Basel, 4031
About this study
Official title: A Pilotstudy on Pathogenesis and Cerebrovascular Manifestations of Septic Encephalopathy
Septic encephalopathy is an important complication of sepsis. Why some patients with sepsis develop septic encephalopathy is unknown. We will investigate whether patients who develop this condition have different patterns of cerebrovascular reactivity and whether it is possible to predict the development of septic encephalopathy from early measurements of cerebral perfusion or from the EEG. We will specifically test the hypotheses that septic encephalopathy may not be predicted by changes in the EEG, and that cerebrovascular autoregulation is not dysfunctional in septic encephalopathy.
- Conditions
- Sepsis
- Keywords
- sepsis, encephalopathy, cerebral perfusion, electroencephalogram
- Medical subject headings
- Sepsis, Brain Diseases
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2006 (estimated)
- Study startJan 2007
- Study completionJul 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SepsisStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Investigators
- Luzius A Steiner, MD PhD, Principal investigator, Department of Anesthesia, University of Basel Hospital, Basel, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00410111
- Sponsor's protocol ID
- EKBB 226/06
- Status last verified
- Oct 2008
- First submitted
- 11 Dec 2006
- Last updated
- 16 Oct 2008
- Results posted
- No
Publications
Pfister D, Siegemund M, Dell-Kuster S, Smielewski P, Ruegg S, Strebel SP, Marsch SC, Pargger H, Steiner LA. Cerebral perfusion in sepsis-associated delirium. Crit Care. 2008;12(3):R63. doi: 10.1186/cc6891. Epub 2008 May 5.
PubMed 18457586
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilotstudy on Pathogenesis and Cerebrovascular Manifestations of Septic Encephalopathy
- ClinicalTrials.gov ID
- NCT00410111
- Acronym / sponsor ID
- EKBB 226/06
- Conditions
- Sepsis
- Keywords
- sepsis, encephalopathy, cerebral perfusion, electroencephalogram
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- Jan 2007
- Study completion
- Jul 2007 (actual)
- First posted
- 12 Dec 2006 (estimated)
- 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.
Septic encephalopathy is an important complication of sepsis. Why some patients with sepsis develop septic encephalopathy is unknown. We will investigate whether patients who develop this condition have different patterns of cerebrovascular reactivity and whether it is possible to predict the development of septic encephalopathy from early measurements of cerebral perfusion or from the EEG. We will specifically test the hypotheses that septic encephalopathy may not be predicted by changes in the EEG, and that cerebrovascular autoregulation is not dysfunctional in septic encephalopathy.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with sepsis, severe sepsis or septic shock admitted to an intensive care unit
Key inclusion criteria (2 listed)
- Sepsis
- Admission to ICU
Key exclusion criteria (2 listed)
- CNS infection
- History of cerebrovascular disease
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
Not reported in the source record.
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 16 Oct 2008.
- Derived from this study: PubMed 18457586Pfister D, Siegemund M, Dell-Kuster S, Smielewski P, Ruegg S, Strebel SP, Marsch SC, Pargger H, Steiner LA. Cerebral perfusion in sepsis-associated delirium. Crit Care. 2008;12(3):R63. doi: 10.1186/cc6891. Epub 2008 May 5.
Related trials for Sepsis
Active, not recruiting
CT for Personalized Mechanical Ventilation
Ventilator-Induced Lung Injury, Sepsis Syndrome
Not yet recruiting
Double Plasma Separation and Adsorption in Acute-on-Chronic Liver Failure (DPMAS-ACLF Trial)
Acute-on-Chronic Liver Failure (ACLF)
Not yet recruiting
Vitamin C for Acute Kidney Injury in ACLF With Septic Shock: A Randomized Controlled Trial
Acute-on-Chronic Liver Failure (ACLF)
RecruitingPhase 4
A Study to Compare the Efficacy and Safety of Extended and Intermittent Infusion of Beta-lactams in Critically Ill Paediatric Patients
Infection, Sepsis
Not yet recruiting
Integrated Medicine for Sepsis: An RCT With Phenotyping
Sepsis
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.
Luzius A Steiner, MD PhD principal investigator
Department of Anesthesia, University of Basel Hospital, Basel, Switzerland
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 Sepsis, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
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 2 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 16 Oct 2008. 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 Switzerland. 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.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00410111, which also lists 1 linked publication.
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 16 Oct 2008; AzTrials last refreshed its copy on 7 Nov 2026.