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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
History of Changes
  Purpose

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
Sepsis

Study Type: Observational
Study Design: 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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University Hospital, Bonn:

Primary Outcome Measures:
  • short form-36 [ Time Frame: 3 month after discharge ] [ Designated as safety issue: No ]

Estimated Enrollment: 72
Study Start Date: January 2009
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

patients treated at the Intensive Care Unit of a University Hospital

Criteria

Inclusion Criteria:

  • patients suffering from sepsis, severe sepsis or septic shock

Exclusion Criteria:

  • pregnancy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00793078

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

No publications provided

Responsible Party: Priv.-Doz. Dr. med. Martin Soehle, D.E.S.A., Dept. of Anaesthesiology and Intensive Care Medicine, University of Bonn
ClinicalTrials.gov Identifier: NCT00793078     History of Changes
Other Study ID Numbers: VCS2009
Study First Received: November 17, 2008
Last Updated: February 28, 2011
Health Authority: Germany: Ethics Commission

Keywords provided by University Hospital, Bonn:
sepsis
arterial blood pressure
complexity
variability

Additional relevant MeSH terms:
Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes

ClinicalTrials.gov processed this record on June 17, 2013