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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT01184430
Other study ID # Algebra
Secondary ID
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


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
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