Arterial Blood Pressure-complexity in Septic Patients

This study has suspended participant recruitment.
(Awaiting decision on financial support by Deutsche Forschungsgemeinschaft (DFG))
Sponsor:
Information provided by:
University Hospital, Bonn
ClinicalTrials.gov Identifier:
NCT00793078
First received: November 17, 2008
Last updated: February 28, 2011
Last verified: January 2011

November 17, 2008
February 28, 2011
January 2009
December 2012   (final data collection date for primary outcome measure)
short form-36 [ Time Frame: 3 month after discharge ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00793078 on ClinicalTrials.gov Archive Site
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Arterial Blood Pressure-complexity in Septic Patients
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.

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.
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Observational
Observational Model: Case Control
Time Perspective: Prospective
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Probability Sample

patients treated at the Intensive Care Unit of a University Hospital

Sepsis
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Suspended
72
December 2012
December 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • patients suffering from sepsis, severe sepsis or septic shock

Exclusion Criteria:

  • pregnancy
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00793078
VCS2009
No
Priv.-Doz. Dr. med. Martin Soehle, D.E.S.A., Dept. of Anaesthesiology and Intensive Care Medicine, University of Bonn
University Hospital, Bonn
Not Provided
Principal Investigator: Martin Soehle, M.D., D.E.S.A., D. habil. Dept. of Anaesthesiology and Intensive Care Medicine, University of Bonn
University Hospital, Bonn
January 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP