Arterial Blood Pressure-complexity in Septic Patients

February 28, 2011 updated by: University Hospital, Bonn

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.

Study Overview

Status

Suspended

Conditions

Study Type

Observational

Enrollment (Anticipated)

72

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Bonn, Germany, 53105
        • Dept. of Anaesthesiology and Intensive Care Medicine, University of Bonn

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

patients treated at the Intensive Care Unit of a University Hospital

Description

Inclusion Criteria:

  • patients suffering from sepsis, severe sepsis or septic shock

Exclusion Criteria:

  • pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
short form-36
Time Frame: 3 month after discharge
3 month after discharge

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2009

Primary Completion (Anticipated)

December 1, 2012

Study Completion (Anticipated)

December 1, 2012

Study Registration Dates

First Submitted

November 17, 2008

First Submitted That Met QC Criteria

November 17, 2008

First Posted (Estimate)

November 19, 2008

Study Record Updates

Last Update Posted (Estimate)

March 1, 2011

Last Update Submitted That Met QC Criteria

February 28, 2011

Last Verified

January 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VCS2009

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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