We updated the design of this site on September 25th. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Arterial Blood Pressure-complexity in Septic Patients

This study has suspended participant recruitment.
(Awaiting decision on financial support by Deutsche Forschungsgemeinschaft (DFG))
Sponsor:
ClinicalTrials.gov Identifier:
NCT00793078
First Posted: November 19, 2008
Last Update Posted: March 1, 2011
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.
Information provided by:
University Hospital, Bonn
  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:


Further study details as provided by University Hospital, Bonn:

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

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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
Criteria

Inclusion Criteria:

  • patients suffering from sepsis, severe sepsis or septic shock

Exclusion Criteria:

  • pregnancy
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): 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

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
First Submitted: November 17, 2008
First Posted: November 19, 2008
Last Update Posted: March 1, 2011
Last Verified: January 2011

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