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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified August 2013 by Charite University, Berlin, Germany
Sponsor:
Information provided by (Responsible Party):
Michael Sander, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:
NCT01184430
First received: August 17, 2010
Last updated: August 8, 2013
Last verified: August 2013
  Purpose

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.


Condition Intervention
Postoperative Wound Infection
Postoperative Outcome
Device: Pulse contour cardiac output device

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Monocentric Pilot Study of Effect of Perioperative Hemodynamic Optimization on the Immune Function Parameters of Peripheral Blood Monocytes After Cardiac Surgery

Resource links provided by NLM:


Further study details as provided by Charite University, Berlin, Germany:

Primary Outcome Measures:
  • HLA-DR Expression on monocytes after surgery [ Time Frame: 24 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • ICU stay [ Time Frame: 24 hours ] [ Designated as safety issue: No ]

Estimated Enrollment: 40
Study Start Date: August 2013
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Non calibrated pulse contour cardiac output monitor
No Intervention: standard monitoring
hemodynamic monitoring based on the standard operating procedures of our clinic

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01184430

Contacts
Contact: Michael Sander, MD +49 30 450 531 ext 012 Michael.Sander@charite.de
Contact: Katharina Berger, MD +49 30 450 531 ext 052 Katharina.Berger@charite.de

Locations
Germany
Department of Anesthesiology and Intensive Care Medicine Campus Charité Mitte / Campus Virchow-Klinikum Not yet recruiting
Berlin, Germany, 10117
Contact: Michael Sander, MD    +4930 450 531 ext 052    Michael.Sander@charite.de   
Principal Investigator: Michael Sander, MD         
Sponsors and Collaborators
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
  More Information

No publications provided

Responsible Party: Michael Sander, Vice Chair, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT01184430     History of Changes
Other Study ID Numbers: Algebra
Study First Received: August 17, 2010
Last Updated: August 8, 2013
Health Authority: Germany: Ethics Commission

Keywords provided by Charite University, Berlin, Germany:
advanced hemodynamic monitoring
goal-directed therapy
cardiac surgery
hemodynamic monitoring

Additional relevant MeSH terms:
Wound Infection
Surgical Wound Infection
Infection
Wounds and Injuries
Postoperative Complications
Pathologic Processes

ClinicalTrials.gov processed this record on October 19, 2014