SepsisNCT01029080
Cerebrovascular Autoregulation During Sepsis
An observational study of Sepsis and Delirium, run by Johannes Gutenberg University Mainz at 1 site in Germany.
Trial summary
The aim of the study is to correlate the dynamic cerebrovascular autoregulation by patients with sepsis with a sepsis-associated delirium. Read more about this study
- Who is it for?
- Ages 18 years and older
- How many people
- 30 participants
- Where
- 1 siteGermany
- Study dates
- Dec 2009to Mar 2011
- 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: All patients at intensive care unit were screened to symptoms that definate sepsis
Who may be able to join
- clinical symptoms of sepsis, severe sepsis and septic shock
- possibility for measurement of transcranial doppler ultrasound
- age over 18 years
Who cannot join
- preexisting cerebrovascular disease
- preexisting immunological disease
- traumatic brain injury
- intracranial infectious disease
- pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Dynamic Cerebrovascular Autoregulation During Sepsis and Sepsis-associated Delirium
The aim of the study is to correlate the dynamic cerebrovascular autoregulation by patients with sepsis with a sepsis-associated delirium.
- Being tested
- no interventions
- Keywords
- Brain, blood flow, Measurement techniques, flow velocity waveform analysis, Monitoring, intensive care, Sepsis, transcranial doppler ultrasound (TCD), Cerebrovascular autoregulation, sepsis-associated delir
- Medical subject headings
- Sepsis, Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no interventionsOther
No interventions
| Study group | Role | What they receive |
|---|---|---|
| Sepsis | All patients with sepsis defined by actually sepsis guidelines Receives: Other: no interventions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disturbed cerebrovascular autoregulation correlates with sepsis associated delir
The Index of autoregulation (Mx) was measured and correlated with the clinical incidence of a sepsis associated delir
Measured: 1 year
Secondary outcomes (2)
Correlation between inflammatory parameters and disturbed cerebrovascular autoregulation
Measured: 1 year
Correlation between inflammatory parameters and sepsis-associated delirium
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2009 (estimated)
- Study startDec 2009
- Primary completionDec 2010
- Study completionMar 2011
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.
- 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
- Prospective
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johannes Gutenberg University Mainz
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Patrick Schramm, Johannes Gutenberg University Mainz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01029080
- Sponsor's protocol ID
- 837.435.08
- Status last verified
- Apr 2013
- First submitted
- 8 Dec 2009
- Last updated
- 15 Apr 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Schramm P, Klein KU, Falkenberg L, Berres M, Closhen D, Werhahn KJ, David M, Werner C, Engelhard K. Impaired cerebrovascular autoregulation in patients with severe sepsis and sepsis-associated delirium. Crit Care. 2012 Oct 4;16(5):R181. doi: 10.1186/cc11665.
PubMed 23036135
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dynamic Cerebrovascular Autoregulation During Sepsis and Sepsis-associated Delirium
- ClinicalTrials.gov ID
- NCT01029080
- Acronym / sponsor ID
- 837.435.08
- Keywords
- Brain, blood flow, Measurement techniques, flow velocity waveform analysis, Monitoring, intensive care, Sepsis, transcranial doppler ultrasound (TCD), Cerebrovascular autoregulation, sepsis-associated delir
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Johannes Gutenberg University MainzUniversity, hospital or other
- Study start
- Dec 2009
- Primary completion
- Dec 2010 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 9 Dec 2009 (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.
The aim of the study is to correlate the dynamic cerebrovascular autoregulation by patients with sepsis with a sepsis-associated delirium.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sepsis | – | Other: no interventionsAll patients with sepsis defined by actually sepsis guidelines |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients at intensive care unit were screened to symptoms that definate sepsis
Key inclusion criteria (3 listed)
- clinical symptoms of sepsis, severe sepsis and septic shock
- possibility for measurement of transcranial doppler ultrasound
- age over 18 years
Key exclusion criteria (5 listed)
- preexisting cerebrovascular disease
- preexisting immunological disease
- traumatic brain injury
- intracranial infectious disease
- pregnancy
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 |
|---|---|---|
| no interventionsNo interventions | Other | Sepsis |
Primary outcome
Disturbed cerebrovascular autoregulation correlates with sepsis associated delir
Time frame: 1 year
The Index of autoregulation (Mx) was measured and correlated with the clinical incidence of a sepsis associated delir
2 secondary outcomes
Correlation between inflammatory parameters and disturbed cerebrovascular autoregulation
Time frame: 1 year
Correlation between inflammatory parameters and sepsis-associated delirium
Time frame: 1 year
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 15 Apr 2013.
- Results publication: PubMed 23036135Schramm P, Klein KU, Falkenberg L, Berres M, Closhen D, Werhahn KJ, David M, Werner C, Engelhard K. Impaired cerebrovascular autoregulation in patients with severe sepsis and sepsis-associated delirium. Crit Care. 2012 Oct 4;16(5):R181. doi: 10.1186/cc11665.
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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 Sepsis and Delirium, run by Johannes Gutenberg University Mainz 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 5 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 15 Apr 2013. 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?
Disturbed cerebrovascular autoregulation correlates with sepsis associated delir (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01029080, 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 15 Apr 2013.