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

Study Overview
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Brief Summary
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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.

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

Conditions
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Postoperative Wound Infection, Postoperative Outcome

Intervention / Treatment
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* Device: Pulse contour cardiac output device


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ICU stay |  | 24 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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advanced hemodynamic monitoring, goal-directed therapy, cardiac surgery, hemodynamic monitoring