Effect of Perioperative Hemodynamic Optimization on the Immune Function Parameters of Peripheral Blood Monocytes After Cardiac Surgery (Algebra)
Primary Purpose
Postoperative Wound Infection, Postoperative Outcome
Status
Unknown status
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Pulse contour cardiac output device
Sponsored by
About this trial
This is an interventional treatment trial for Postoperative Wound Infection focused on measuring advanced hemodynamic monitoring, goal-directed therapy, cardiac surgery, hemodynamic monitoring
Eligibility 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
Sites / Locations
- Department of Anesthesiology and Intensive Care Medicine Campus Charité Mitte / Campus Virchow-Klinikum
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
advanced hemodynamic monitoring
standard monitoring
Arm Description
advanced hemodynamic monitoring with pulse contour analysis ( LiDCO rapid) and goal-directed therapy
hemodynamic monitoring based on the standard operating procedures of our clinic
Outcomes
Primary Outcome Measures
HLA-DR Expression on monocytes after surgery
Secondary Outcome Measures
ICU stay
Full Information
NCT ID
NCT01184430
First Posted
August 17, 2010
Last Updated
August 8, 2013
Sponsor
Charite University, Berlin, Germany
1. Study Identification
Unique Protocol Identification Number
NCT01184430
Brief Title
Effect of Perioperative Hemodynamic Optimization on the Immune Function Parameters of Peripheral Blood Monocytes After Cardiac Surgery
Acronym
Algebra
Official Title
Monocentric Pilot Study of Effect of Perioperative Hemodynamic Optimization on the Immune Function Parameters of Peripheral Blood Monocytes After Cardiac Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
August 2013
Overall Recruitment Status
Unknown status
Study Start Date
August 2013 (undefined)
Primary Completion Date
March 2014 (Anticipated)
Study Completion Date
December 2014 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Charite University, Berlin, Germany
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Wound Infection, Postoperative Outcome
Keywords
advanced hemodynamic monitoring, goal-directed therapy, cardiac surgery, hemodynamic monitoring
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
advanced hemodynamic monitoring
Arm Type
Active Comparator
Arm Description
advanced hemodynamic monitoring with pulse contour analysis ( LiDCO rapid) and goal-directed therapy
Arm Title
standard monitoring
Arm Type
No Intervention
Arm Description
hemodynamic monitoring based on the standard operating procedures of our clinic
Intervention Type
Device
Intervention Name(s)
Pulse contour cardiac output device
Other Intervention Name(s)
Non calibrated pulse contour cardiac output monitor
Intervention Description
Goal directed volume therapy using stroke volume variation and cardiac output to guide volume therapy and inotropic support.
Primary Outcome Measure Information:
Title
HLA-DR Expression on monocytes after surgery
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
ICU stay
Time Frame
24 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Michael Sander, MD
Phone
+49 30 450 531
Ext
012
Email
Michael.Sander@charite.de
First Name & Middle Initial & Last Name or Official Title & Degree
Katharina Berger, MD
Phone
+49 30 450 531
Ext
052
Email
Katharina.Berger@charite.de
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Sander, MD
Organizational Affiliation
Dept. of Anesthesiology Charité Universitaetsmedizin Berlin
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Claudia Spies, MD
Organizational Affiliation
Dept. of Anesthesiology Charité Universitaetsmedizin Berlin
Official's Role
Study Chair
Facility Information:
Facility Name
Department of Anesthesiology and Intensive Care Medicine Campus Charité Mitte / Campus Virchow-Klinikum
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael Sander, MD
Phone
+4930 450 531
Ext
052
Email
Michael.Sander@charite.de
First Name & Middle Initial & Last Name & Degree
Michael Sander, MD
12. IPD Sharing Statement
Learn more about this trial
Effect of Perioperative Hemodynamic Optimization on the Immune Function Parameters of Peripheral Blood Monocytes After Cardiac Surgery
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