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

Postoperative Wound Infection Clinical Trial

— Algebra  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01184430
• Other study ID #: Algebra
• Status: Not yet recruiting
• Phase: N/A
• First received: August 17, 2010
• Last updated: August 8, 2013
• Start date: August 2013
• Est. completion date: December 2014

Study information

• Verified date: August 2013
• Source: Charite University, Berlin, Germany
• Contact: Michael Sander, MD
• Phone: +49 30 450 531
• Email: Michael.Sander[@]charite.de
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: December 2014
• Est. primary completion date: March 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Postoperative Outcome
• Postoperative Wound Infection
• Surgical Wound Infection
• Wound Infection

Intervention

Device:
• Pulse contour cardiac output device
Goal directed volume therapy using stroke volume variation and cardiac output to guide volume therapy and inotropic support.

Locations

Country	Name	City	State
Germany	Department of Anesthesiology and Intensive Care Medicine Campus Charité Mitte / Campus Virchow-Klinikum	Berlin

Sponsors (1)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	HLA-DR Expression on monocytes after surgery		24 hours	No
Secondary	ICU stay		24 hours	No