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

Not Applicable

• Conditions: Postoperative Wound Infection; Postoperative Outcome
• Interventions: Device: Pulse contour cardiac output device

• Registration Number: NCT01184430
• Lead Sponsor: Charite University, Berlin, Germany

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-08-17
• Study First Submitted QC: 2010-08-18
• Study First Posted: 2010-08-19
• Status Verified: 2013-08
• Study Start: 2013-08
• Last Update Submitted: 2013-08-08
• Last Update Posted: 2013-08-12
• Primary Completion: 2014-03
• Study Completion: 2014-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 40

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
advanced hemodynamic monitoring	Pulse contour cardiac output device	advanced hemodynamic monitoring with pulse contour analysis ( LiDCO rapid) and goal-directed therapy

Primary Outcome Measures

Name	Time	Method
HLA-DR Expression on monocytes after surgery	24 hours

Secondary Outcome Measures

Name	Time	Method
ICU stay	24 hours

Trial Locations

Locations (1)

Department of Anesthesiology and Intensive Care Medicine Campus Charité Mitte / Campus Virchow-Klinikum; 🇩🇪 Berlin, Germany