Effect of Perioperative Hemodynamic Optimization on the Immune Function Parameters of Peripheral Blood Monocytes After Cardiac Surgery (Algebra)

August 8, 2013 updated by: Michael Sander, Charite University, Berlin, Germany

Monocentric Pilot Study of Effect of Perioperative Hemodynamic Optimization on the Immune Function Parameters of Peripheral Blood Monocytes After Cardiac Surgery

Cardiac surgery patients have a high risk to suffer from postoperative infections. Some studies have shown, that humoral and cellular factors are associated with perioperative immunodysfunction and can increase the risk of postoperative infections. Monocytes in the blood and, especially alveolar macrophages are important for an adequate host defence. In studies the investigators have shown that hemodynamic parameters have a significant influence on the probability to develop postoperative infections. The aim of the study is to investigate, whether cardiac surgery patients have an altered immune function after surgery that is predictive for the latter development of subsequent infections and whether they benefit from a goal-directed volume and hemodynamic therapy.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

40

Phase

  • Not Applicable

Contacts and Locations

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

Study Contact

Study Contact Backup

Study Locations

  • Germany
      • Berlin, Germany, 10117
        • Department of Anesthesiology and Intensive Care Medicine Campus Charité Mitte / Campus Virchow-Klinikum
        • Contact:
        • Principal Investigator:
          • Michael Sander, MD

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

Description

Inclusion Criteria:

  • elective cardiac surgery patient undergoing cardiopulmonary bypass
  • signed informed consent

Exclusion Criteria:

  • pregnant or breast feeding women
  • Age <18 years
  • pulmonary disease with an oxygenation index <300mmHg
  • liver disease (>Child B)
  • HIV-Infection
  • Therapy with corticosteroids
  • Condition after transplantation
  • preexisting infection before operation

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

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: advanced hemodynamic monitoring
advanced hemodynamic monitoring with pulse contour analysis ( LiDCO rapid) and goal-directed therapy
Device: Pulse contour cardiac output device
Goal directed volume therapy using stroke volume variation and cardiac output to guide volume therapy and inotropic support.
Other Names:
  • Non calibrated pulse contour cardiac output monitor
No Intervention: standard monitoring
hemodynamic monitoring based on the standard operating procedures of our clinic

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
HLA-DR Expression on monocytes after surgery
Time Frame: 24 hours
24 hours

Secondary Outcome Measures

Outcome Measure
Time Frame
ICU stay
Time Frame: 24 hours
24 hours

Collaborators and Investigators

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

Sponsor

Charite University, Berlin, Germany

Investigators

  • Principal Investigator: Michael Sander, MD, Dept. of Anesthesiology Charité Universitaetsmedizin Berlin
  • Study Chair: Claudia Spies, MD, Dept. of Anesthesiology Charité Universitaetsmedizin Berlin

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

August 1, 2013

Primary Completion (Anticipated)

March 1, 2014

Study Completion (Anticipated)

December 1, 2014

Study Registration Dates

First Submitted

August 17, 2010

First Submitted That Met QC Criteria

August 18, 2010

First Posted (Estimate)

August 19, 2010

Study Record Updates

Last Update Posted (Estimate)

August 12, 2013

Last Update Submitted That Met QC Criteria

August 8, 2013

Last Verified

August 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Algebra

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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