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

Charité University Medicine Berlin

Status: Unknown

Conditions: Postoperative Outcome; Postoperative Wound Infection

Treatments: Device: Pulse contour cardiac output device

Study type: Interventional

Funder types: Other

Identifiers

NCT01184430

Algebra

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

advanced hemodynamic monitoring

Active Comparator group

Description:

advanced hemodynamic monitoring with pulse contour analysis ( LiDCO rapid) and goal-directed therapy

Treatment:

Device: Pulse contour cardiac output device

standard monitoring

No Intervention group

Description:

hemodynamic monitoring based on the standard operating procedures of our clinic