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Arterial Blood Pressure-complexity in Septic Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00793078
Recruitment Status : Suspended (Awaiting decision on financial support by Deutsche Forschungsgemeinschaft (DFG))
First Posted : November 19, 2008
Last Update Posted : March 1, 2011
Information provided by:
University Hospital, Bonn

Brief 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 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.

Condition or disease

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Study Type : Observational
Estimated Enrollment : 72 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Investigation of Arterial Blood Pressure-complexity and Its Relation to Outcome in Comparison Between Cardiac Surgery Versus Non-cardiac Surgery Septic Patients
Study Start Date : January 2009
Estimated Primary Completion Date : December 2012
Estimated Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Sepsis

Primary Outcome Measures :
  1. short form-36 [ Time Frame: 3 month after discharge ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
patients treated at the Intensive Care Unit of a University Hospital

Inclusion Criteria:

  • patients suffering from sepsis, severe sepsis or septic shock

Exclusion Criteria:

  • pregnancy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00793078

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Dept. of Anaesthesiology and Intensive Care Medicine, University of Bonn
Bonn, Germany, 53105
Sponsors and Collaborators
University Hospital, Bonn
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Principal Investigator: Martin Soehle, M.D., D.E.S.A., D. habil. Dept. of Anaesthesiology and Intensive Care Medicine, University of Bonn

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Responsible Party: Priv.-Doz. Dr. med. Martin Soehle, D.E.S.A., Dept. of Anaesthesiology and Intensive Care Medicine, University of Bonn Identifier: NCT00793078    
Other Study ID Numbers: VCS2009
First Posted: November 19, 2008    Key Record Dates
Last Update Posted: March 1, 2011
Last Verified: January 2011
Keywords provided by University Hospital, Bonn:
arterial blood pressure
Additional relevant MeSH terms:
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Systemic Inflammatory Response Syndrome
Pathologic Processes