Arterial Blood Pressure-complexity in Septic Patients

Sepsis Clinical Trial

Official title:

Investigation of Arterial Blood Pressure-complexity and Its Relation to Outcome in Comparison Between Cardiac Surgery Versus Non-cardiac Surgery Septic Patients

Clinical Trial Details — Status: Suspended

Administrative data

• NCT number: NCT00793078
• Other study ID #: VCS2009
• 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

• Sepsis

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