SepsisNCT00793078
Arterial Blood Pressure-complexity in Septic Patients
An observational study of Sepsis, run by University Hospital, Bonn at 1 site in Germany.
Trial summary
Arterial blood pressure (ABP) is regulated by multiple, interconnected feedback loops resulting in a variable and complex time course. According to the "decomplexification theory of illness", disease is characterised by a loss or impaired function of feedback loops resulting in a decreased complexity of the ABP-time… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sepsis
- How many people
- 72 participants
- Where
- 1 siteGermany
- Study dates
- Jan 2009to Dec 2012
- 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 treated at the Intensive Care Unit of a University Hospital
Who may be able to join
- patients suffering from sepsis, severe sepsis or septic shock
Who cannot join
- pregnancy
Trial locations and contacts
1 site in 1 country.
Germany1 site
Dept. of Anaesthesiology and Intensive Care Medicine, University of Bonn
Bonn, 53105
About this study
Official title: Investigation of Arterial Blood Pressure-complexity and Its Relation to Outcome in Comparison Between Cardiac Surgery Versus Non-cardiac Surgery Septic Patients
Arterial blood pressure (ABP) is regulated by multiple, interconnected feedback loops resulting in a variable and complex time course. According to the "decomplexification theory of illness", disease is characterised by a loss or impaired function of feedback loops resulting in a decreased complexity of the ABP-time course and an impaired adaptability of the cardiovascular system.
Decomplexification of physiologic parameters has been shown to occur in coronary heart disease, Parkinson's and Hodgkin's disease, and in subarachnoid hemorrhage, but has not been evaluated in sepsis.
Read more
This study is intended to test the hypothesis that complexity of ABP
- is lower in cardiac surgery versus non-cardiac surgery septic patients,
- decreases as severity of sepsis increases to severe sepsis and septic shock,
- is associated with outcome three month after sepsis.
- Conditions
- Sepsis
- Keywords
- sepsis, arterial blood pressure, complexity, variability
- Medical subject headings
- Sepsis
What is being measured
The primary outcome is the main question the study is designed to answer.
short form-36
Measured: 3 month after discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2008 (estimated)
- Study startJan 2009
- Primary completionDec 2012 (estimated)
- Study completionDec 2012 (estimated)
Why it stopped: Awaiting decision on financial support by Deutsche Forschungsgemeinschaft (DFG)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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-control
- Time perspective
- Prospective
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bonn
- Sponsor type
- University, hospital or other
- Investigators
- Martin Soehle, M.D., D.E.S.A., D. habil., Principal investigator, Dept. of Anaesthesiology and Intensive Care Medicine, University of Bonn
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00793078
- Sponsor's protocol ID
- VCS2009
- Status last verified
- Jan 2011
- First submitted
- 17 Nov 2008
- Last updated
- 1 Mar 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Arterial Blood Pressure-complexity and Its Relation to Outcome in Comparison Between Cardiac Surgery Versus Non-cardiac Surgery Septic Patients
- ClinicalTrials.gov ID
- NCT00793078
- Acronym / sponsor ID
- VCS2009
- Conditions
- Sepsis
- Keywords
- sepsis, arterial blood pressure, complexity, variability
- Study type
- Observational
- Recruitment status
- SuspendedReason stopped: Awaiting decision on financial support by Deutsche Forschungsgemeinschaft (DFG)
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- University Hospital, BonnUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Dec 2012 (estimated)
- Study completion
- Dec 2012 (estimated)
- First posted
- 19 Nov 2008 (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.
Arterial blood pressure (ABP) is regulated by multiple, interconnected feedback loops resulting in a variable and complex time course. According to the "decomplexification theory of illness", disease is characterised by a loss or impaired function of feedback loops resulting in a decreased complexity of the ABP-time course and an impaired adaptability of the cardiovascular system.
Decomplexification of physiologic parameters has been shown to occur in coronary heart disease, Parkinson's and Hodgkin's disease, and in subarachnoid hemorrhage, but has not been evaluated in sepsis.
This study is intended to test the hypothesis that complexity of ABP
- is lower in cardiac surgery versus non-cardiac surgery septic patients,
- decreases as severity of sepsis increases to severe sepsis and septic shock,
- is associated with outcome three month after sepsis.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients treated at the Intensive Care Unit of a University Hospital
Key inclusion criteria (1 listed)
- patients suffering from sepsis, severe sepsis or septic shock
Key exclusion criteria (1 listed)
- pregnancy
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
short form-36
Time frame: 3 month after discharge
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Mar 2011.
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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.
Martin Soehle, M.D., D.E.S.A., D. habil. principal investigator
Dept. of Anaesthesiology and Intensive Care Medicine, University of Bonn
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, Bonn 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: paused, as of the sponsor's last update on 1 Mar 2011. 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?
Results are not available in the source record.
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?
short form-36 (time frame: 3 month after discharge). 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 1 Mar 2011.