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Clinical Trial Details — Status: Suspended

Administrative data

NCT number NCT00793078
Other study ID # VCS2009
Secondary ID
Status Suspended
Phase N/A
First received November 17, 2008
Last updated February 28, 2011
Start date January 2009
Est. completion date December 2012

Study information

Verified date January 2011
Source University Hospital, Bonn
Contact n/a
Is FDA regulated No
Health authority Germany: Ethics Commission
Study type Observational

Clinical 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 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.


Recruitment information / eligibility

Status Suspended
Enrollment 72
Est. completion date December 2012
Est. primary completion date December 2012
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- patients suffering from sepsis, severe sepsis or septic shock

Exclusion Criteria:

- pregnancy

Study Design

Observational Model: Case Control, Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

Country Name City State
Germany Dept. of Anaesthesiology and Intensive Care Medicine, University of Bonn Bonn

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Bonn

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary short form-36 3 month after discharge No
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